Alzheimer's Disease, Brain Diseases, Central Nervous System Diseases, Cognitive Impairment, Dementia, Mild Cognitive Impairment, Tauopathies
Conditions
Keywords
Alzheimer's Disease, Cognitive Impairment, Tauopathies, Mild Cognitive Impairment, Dementia, Brain Diseases, Central Nervous System Diseases
Brief summary
This study is a multicenter, double blind, randomized, placebo-controlled study to evaluate the safety, tolerability and immunogenicity of different doses, regimens and combinations of Tau targeted vaccines in participants with early Alzheimer's Disease.
Interventions
BIOLOGICALACI-35.030
Administration of a Low dose of ACI-35.030
OTHERPlacebo
Administration of Placebo
BIOLOGICALJACI-35.054
Administration of a Low dose of JACI-35.054
Sponsors
Janssen Research & Development, LLC
AC Immune SA
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female with age from 50 and up to 75 years old inclusive. 2. Mild Cognitive Impairment (MCI) due to AD or Mild AD according to NIA-AA criteria and Clinical Dementia Rating scale (CDR) global score of 0.5 or 1 respectively. 3. Mini Mental State Examination (MMSE) score of 22 or above. 4. Abnormal level of CSF Abeta amyloid 42 (Aß42) consistent with AD pathology at screening. 5. Subjects either not taking any marketed treatment for AD or receiving a stable dose of an acetylcholinesterase inhibitor and/or memantine for at least 3 months prior to baseline. 6. Subjects cared for by a reliable informant or caregiver to assure compliance, assist with clinical assessments and report safety issues. 7. Women must be post-menopausal for at least one year and/or surgically sterilized. 8. Subjects who in the opinion of the investigator is able to understand and provide written informed consent. 9. Both subject and informant or caregiver must be fluent in one of the languages of the study and able to comply with all study procedures, including lumbar punctures.
Exclusion criteria
1. Participation in previous clinical trials for AD and/or for neurological disorders using active immunization unless there is documented evidence that the subject was treated with placebo only and the placebo vaccine is not expected to induce any specific immune response. 2. Participation in previous clinical trials for AD and/or for neurological disorders using any passive immunization within the past 6 months (or 5 half-lives of the investigational antibody, whichever is longer) prior to screening unless there is documented evidence that the subject was treated with placebo only and the placebo is not expected to induce any specific immune response. 3. Participation in previous clinical trials for AD and/or for neurological disorders using any small molecule drug including BACE-1 inhibitors within the past 3 months prior to screening. 4. Concomitant participation in any other clinical trial using experimental or approved medications or therapies. 5. Presence of positive Anti-nuclear Antibody (ANA) titers at a dilution of at least 1:160 in subjects without clinical symptoms of auto-immune disease. 6. Current or past history of auto-immune disease, or clinical symptoms consistent with the presence of auto-immune disease. 7. Immune suppression including but not limited to the use of immunosuppressive drugs or systemic steroids unless they have been prescribed transiently more than 3 months prior to screening. 8. History of severe allergic reaction (e.g., anaphylaxis) including but not limited to severe allergic reaction to previous vaccines and/or medications. 9. Prior history of clinically significant hypoglycaemic episodes. 10. Drug or alcohol abuse or dependence currently met or within the past five years according to Diagnostic and Statistical Manual of Mental Disorders-V (DSM-V) criteria. 11. Any clinically significant medical condition likely to interfere with the evaluation of safety and tolerability of the study treatment and/or the adherence to the full study visit schedule. 12. Any clinically significant medical condition likely to impact the immune system (e.g, any history of acquired or innate immune system disorder). 13. Use of hydralazine, procainamide, quinidine, isoniazide, TNF-inhibitors, minocycline within the last 12 months prior to screening. 14. Use of diltiazem unless on a stable dose for at least 3 months prior to screening. 15. Significant risk of suicide defined, using the Columbia-Suicide Severity Rating Scale, as the subject answering: yes to suicidal ideation questions 4 or 5 or answering: yes to suicidal behavior within the past 12 months. 16. Concomitant psychiatric or neurologic disorder other than those considered to be related to AD. 17. History or presence of uncontrolled seizures. 18. History of meningoencephalitis within the past 10 years prior to screening. 19. Subjects with a history of hemorrhagic and/or non-hemorrhagic stroke. 20. Presence or history of peripheral neuropathy. 21. History of inflammatory neurological disorders with potential for CNS involvement. 22. Screening MRI scan showing structural evidence of alternative pathology not consistent with AD which could cause the subject's symptoms. 23. MRI examination cannot be done for any reason, including but not limited to metal implants contraindicated for MRI studies and/or severe claustrophobia. 24. Significant hearing or visual impairment or other issues judged relevant by the investigator preventing to comply with the protocol and to perform the outcome measures. 25. Clinically significant infections or major surgical operation within 3 months prior to screening. 26. Any vaccine received within the past 2 weeks before screening, including influenza vaccine. 27. Clinically significant arrhythmias or other clinically significant abnormalities on ECG at screening. 28. Myocardial infarction within one year prior to baseline, unstable angina pectoris, or significant coronary artery disease. 29. History of cancer within the past 5 years other than treated squamous cell carcinoma, basal cell carcinoma and melanoma in situ, or in-situ prostate cancer or in-situ breast cancer which have been fully removed and are considered cured. 30. Clinically significant deviations from normal values for hematologic parameters, liver function tests, and other biochemical measures, that are judged to be clinically significant in the opinion of the investigator. 31. Pregnancy confirmed by blood test at screening, or subject planning to be pregnant or lactating. 32. Receipt of any anticoagulant drug or antiplatelet drug, except aspirin at doses of 100 mg daily or lower. 33. Receipt of any antipsychotic drugs unless on stable low doses for the treatment of insomnia. 34. Donation of blood or blood products within 30 days prior to screening or plans to donate blood while participating in the study. 35. Positive Venereal Disease Research Laboratory (VDRL) consistent with active syphilis at screening. 36. Positive HIV test at screening. 37. Laboratory or clinical evidence of active hepatitis B and/or C at screening. 38. Serum creatinine greater than 1.5x upper limit of normal, abnormal thyroid function tests or clinically significant reduction in serum B12 or folate levels.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Endpoint is assessed from baseline (i.e. mean of the titers measured at the screening and visit 1 before the first study drug administration) to the last study visit (week 74), at weeks 0, 2, 8, 10, 24, 26, 36, 48, 50, 67 and 74. | At all visits, blood was collected for the determination of the immune response in serum. Anti-enriched paired helical filaments (ePHF) IgG titers were measured by Meso Scale Discovery (MSD). For each visit, the geometric means (AU/mL) and 95% Confidence Interval (CI) is given. |
| Mean Change From Baseline in Systolic Blood Pressure, ITT Set | Endpoint is assessed from baseline (i.e. last non-missing value prior to the first immunization at week 0) to the last study visit (week 74), at weeks 26, 50 and 74. | At reported visits, systolic blood pressures (mmHg = millimeter of mercury) were measured in sitting position only, after the subject has been sitting down for at least 5 minutes. A change from baseline value is defined as the value at post-baseline timepoint minus the baseline value, i.e. post-baseline value - baseline value |
| Mean Change From Baseline in Heart Rate, ITT Set | Endpoint is assessed from baseline (i.e. last non-missing value prior to the first immunization at week 0) to the last study visit (week 74), at weeks 26, 50 and 74. | At reported visits, heart rates (bpm = beats per minute) were measured in sitting position only, after the subject has been sitting down for at least 5 minutes. A change from baseline value is defined as the value at post-baseline timepoint minus the baseline value, i.e. post-baseline value - baseline value |
| Mean Change From Baseline in Body Temperature, ITT Set | Endpoint is assessed from baseline (i.e. last non-missing value prior to the first immunization at week 0) to the last study visit (week 74), at weeks 26, 50 and 74. | At reported visits, body temperatures (°C = degree Celsius) were measured. A change from baseline value is defined as the value at post-baseline timepoint minus the baseline value, i.e. post-baseline value - baseline value |
| Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set | Endpoint is assessed from baseline (i.e. last non-missing value prior to the first immunization at Visit 1 (Week 0) or Screening) to the last study visit (week 74), at weeks 26, 50 and 74. | Suicidal ideation or behavior using Columbia-Suicide Severity Rating Scale (C-SSRS) was assessed at Baseline (screening or visit 1 (Week 0)) and at weeks 26, 50 and 74. A set of questions related to suicidal behavior or ideation was directly asked by the rater to the subject. |
| Number of Participants With Abnormal MRI Results, ITT Set | Endpoint is assessed from baseline (screening) to the last study visit (week 74), at weeks 10, 26, 50 and 74. | Brain MRI scans were conducted according to the schedule of assessments, i.e. at Baseline (screening) and at weeks 10, 26, 50, 74 and examined for evidence of brain pathology. Normal, abnormal not clinically significant (NCS) and abnormal clinically significant (CS) results as interpreted by the clinical site are reported. |
| Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Endpoint is assessed from baseline (i.e. mean of the titers measured at the screening and visit 1 before the first study drug administration) to the last study visit (week 74), at weeks 0, 2, 8, 10, 24, 26, 36, 48, 50, 67 and 74. | At all visits, blood was collected for the determination of the immune response in serum. Anti-phosphorylated Tau (pTau) IgG titers were measured by Meso Scale Discovery (MSD). For each visit, the geometric means (AU/mL) and 95% Confidence Interval (CI) is given. |
| Overview of Treatment-Emergent Adverse Events, Safety Set | AEs falling between first dosing (week 0) and last study visit (week 74), ie up to 74 weeks, defined as Treatment-Emergent Adverse Events (TEAEs) | Categorical data are presented with the number of subjects with at least one event for the defined categories. Subjects are included only once, even if they experienced multiple events in a category. |
| Overview of Treatment-Emergent Adverse Events Assessed by Intensity, Safety Set | Between the first dosing and the last study visit (week 74) | Categorical data are presented with the number of subjects with at least one Treatment-Emergent Adverse Event (TEAE) assessed as: * Mild: Easily tolerated and causes minimal discomfort and does not interfere with everyday activities. * Moderate: Sufficiently discomforting to interfere with normal everyday activities; intervention may be needed. Event is not hazardous to the subject's health * Severe: Prevents normal everyday activities; treatment or other intervention usually needed. Hazard to the subject's health Although subjects may have experienced multiple events, they are included only once, in the maximum severity category |
| Overview of Treatment-Emergent Adverse Events Assessed by Relationship to Study Drug, Safety Set | Between the first dosing and the last study visit (week 74) | Categorical data are presented with the number of subjects with at least one Treatment-Emergent Adverse Event (TEAE) assessed as: * Unrelated: Events reported as unrelated or unlikely related to study drug * Related: Events reported as possibly related or probably related to study drug Although subjects may have experienced multiple events, they are included only once, in the strongest relationship category |
| Mean Change From Baseline in Diastolic Blood Pressure, ITT Set | Endpoint is assessed from baseline (i.e. last non-missing value prior to the first immunization at week 0) to the last study visit (week 74), at weeks 26, 50 and 74. | At reported visits, diastolic blood pressures (mmHg = millimeter of mercury) were measured in sitting position only, after the subject has been sitting down for at least 5 minutes. A change from baseline value is defined as the value at post-baseline timepoint minus the baseline value, i.e. post-baseline value - baseline value |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Endpoint is assessed from baseline (i.e. mean of the titers measured at the screening and visit 1 before the first study drug administration) to the last study visit (week 74), at weeks 0, 2, 8, 10, 24, 26, 36, 48, 50, 67 and 74. | At all visits, blood was collected for the determination of the immune response in serum. Anti-Tau IgG titers were measured by Meso Scale Discovery (MSD). For each visit, the geometric means (AU/mL) and 95% Confidence Interval (CI) is given. |
| Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Endpoint is assessed from baseline (i.e. mean of the titers measured at the screening and visit 1 before the first study drug administration) to the last study visit (week 74), at weeks 0, 2, 8, 10, 24, 26, 36, 48, 50, 67 and 74. | At all visits, blood was collected for the determination of the immune response in serum. Anti-phosphorylated Tau (pTau) IgM titers were measured by enzyme-linked immunosorbent assay (ELISA). For each visit, the geometric means (AU/mL) and 95% Confidence Interval (CI) is given. |
| Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Endpoint is assessed from baseline (i.e. mean of the titers measured at the screening and visit 1 before the first study drug administration) to the last study visit (week 74), at weeks 0, 2, 8, 10, 24, 26, 36, 48, 50, 67 and 74. | At all visits, blood was collected for the determination of the immune response in serum. Anti-Tau IgM titers were measured by enzyme-linked immunosorbent assay (ELISA). For each visit, the geometric means (AU/mL) and 95% Confidence Interval (CI) is given. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline of Cognitive Performance Using RBANS Scale | from baseline up to week 74 | RBANS means Repeatable Battery for the Assessment of Neuropsychological Status. The total scale index score ranges from 40 to 160. A higher score indicates a better outcome. |
| Change From Baseline of Behavior Using NPI Scale | from baseline up to week 74 | NPI means Neuropsychiatric Inventory. The score ranges from 0 to 144. A higher score indicates a worse outcome. |
| Change From Baseline of Functional Performance Using CDR-SB Scale | from baseline up to week 74 | CDR-SB means Clinical Dementia Rating - Sum of Boxes. The score ranges from 0 to 18. A higher score indicates a worse outcome. |
Countries
Finland, Netherlands, Sweden, United Kingdom
Participant flow
Recruitment details
Recruitment was performed in Finland, the Netherlands, Sweden and the UK. 79 subjects were screened for the study; 22 subjects did not meet the eligibility criteria; 1 subject was re-screened and qualified to participate.
Pre-assignment details
Screening details: Subjects between 50 and 75 years at screening with Mild Cognitive Impairment (MCI) due to AD or Mild AD according to NIA-AA criteria, providing a written informed consent and fulfilling all further inclusion criteria could enter the clinical trial.
Participants by arm
| Arm | Count |
|---|---|
| Sub-Cohort 1.1 (ACI-35.030 300 μg) Subjects receiving 4 doses of ACI-35.030 300 μg at week 0, 8, 24 and 48 | 6 |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) Subjects receiving 4 doses of ACI-35.030 900 μg at week 0, 8, 24 and 48 | 19 |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) Subjects receiving 4 doses of ACI-35.030 1800 μg at week 0, 8, 24 and 48 | 6 |
| Cohort 1 Placebo Subjects receiving 4 doses of placebo at week 0, 8, 24 and 48. The placebo subjects of the 3 sub-cohorts 1.1, 1.2 and 1.3 (cohort 1) are pooled to represent one group. Randomization and distribution of the subjects in cohort 1 was as follows:
* Cohort 1.1: 8 patients (6 active, 2 placebo)
* Cohort 1.2: 25 patients (19 active, 6 placebo)
* Cohort 1.3: 8 patients (6 active, 2 placebo) | 10 |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) Subjects receiving 4 doses of JACI-35.054 15 μg at week 0, 8, 24 and 48 | 6 |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) Subjects receiving 4 doses of JACI-35.054 60 μg at week 0, 8, 24 and 48 | 6 |
| Cohort 2 Placebo Subjects receiving 4 doses of placebo at week 0, 8, 24 and 48. The placebo subjects of the 2 sub cohorts 2.1 and 2.2 (cohort 2) are pooled to represent one group. Randomization and distribution of the subjects in cohort 2 was as follows:
* Cohort 2.1: 8 patients (6 active, 2 placebo)
* Cohort 2.2: 8 patients (6 active, 2 placebo) | 4 |
| Total | 57 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Overall Study | Subject withdrawal by caregiver | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 1 | 1 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Sub-Cohort 1.1 (ACI-35.030 300 μg) | Sub-Cohort 1.2 (ACI-35.030 900 μg) | Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Cohort 1 Placebo | Sub-Cohort 2.1 (JACI-35.054 15 μg) | Sub-Cohort 2.2 (JACI-35.054 60 μg) | Cohort 2 Placebo | Total |
|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 13 Participants | 4 Participants | 8 Participants | 5 Participants | 1 Participants | 3 Participants | 37 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 6 Participants | 2 Participants | 2 Participants | 1 Participants | 5 Participants | 1 Participants | 20 Participants |
| Age, Continuous | 65.5 years STANDARD_DEVIATION 5.01 | 68.0 years STANDARD_DEVIATION 6.29 | 64.7 years STANDARD_DEVIATION 4.63 | 67.7 years STANDARD_DEVIATION 4.6 | 66.7 years STANDARD_DEVIATION 6.22 | 63.0 years STANDARD_DEVIATION 4.77 | 68.0 years STANDARD_DEVIATION 6.16 | 66.67 years STANDARD_DEVIATION 5.54 |
| Clinical Dementia Rating (CDR) - Global Score Score = 0.5 | 6 Participants | 17 Participants | 5 Participants | 8 Participants | 6 Participants | 5 Participants | 3 Participants | 50 Participants |
| Clinical Dementia Rating (CDR) - Global Score Score = 1 | 0 Participants | 2 Participants | 1 Participants | 2 Participants | 0 Participants | 1 Participants | 1 Participants | 7 Participants |
| Concomitant Medication Acetylcholinesterase Inhibitors and/or Memantine | 5 Participants | 14 Participants | 5 Participants | 8 Participants | 3 Participants | 5 Participants | 4 Participants | 44 Participants |
| Concomitant Medication No Acetylcholinesterase Inhibitors or Memantine | 1 Participants | 5 Participants | 1 Participants | 2 Participants | 3 Participants | 1 Participants | 0 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 18 Participants | 6 Participants | 10 Participants | 6 Participants | 6 Participants | 4 Participants | 56 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Mini Mental State Examination (MMSE) Total score | 27.5 units on a scale STANDARD_DEVIATION 0.84 | 26.1 units on a scale STANDARD_DEVIATION 2.02 | 26.0 units on a scale STANDARD_DEVIATION 2.68 | 26.1 units on a scale STANDARD_DEVIATION 3.11 | 28.0 units on a scale STANDARD_DEVIATION 1.55 | 25.7 units on a scale STANDARD_DEVIATION 3.61 | 24.5 units on a scale STANDARD_DEVIATION 2.52 | 26.28 units on a scale STANDARD_DEVIATION 2.46 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 19 Participants | 6 Participants | 10 Participants | 6 Participants | 6 Participants | 4 Participants | 57 Participants |
| Region of Enrollment Finland | 6 participants | 6 participants | 2 participants | 7 participants | 3 participants | 4 participants | 4 participants | 32 participants |
| Region of Enrollment Netherlands | 0 participants | 6 participants | 2 participants | 2 participants | 3 participants | 1 participants | 0 participants | 14 participants |
| Region of Enrollment Sweden | 0 participants | 4 participants | 0 participants | 1 participants | 0 participants | 1 participants | 0 participants | 6 participants |
| Region of Enrollment United Kingdom | 0 participants | 3 participants | 2 participants | 0 participants | 0 participants | 0 participants | 0 participants | 5 participants |
| Sex: Female, Male Female | 4 Participants | 9 Participants | 2 Participants | 5 Participants | 3 Participants | 3 Participants | 4 Participants | 30 Participants |
| Sex: Female, Male Male | 2 Participants | 10 Participants | 4 Participants | 5 Participants | 3 Participants | 3 Participants | 0 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 19 | 0 / 6 | 0 / 10 | 0 / 6 | 0 / 6 | 0 / 4 |
| other Total, other adverse events | 6 / 6 | 17 / 19 | 6 / 6 | 8 / 10 | 6 / 6 | 6 / 6 | 4 / 4 |
| serious Total, serious adverse events | 2 / 6 | 2 / 19 | 2 / 6 | 0 / 10 | 0 / 6 | 0 / 6 | 1 / 4 |
Outcome results
Primary
Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set
At all visits, blood was collected for the determination of the immune response in serum. Anti-enriched paired helical filaments (ePHF) IgG titers were measured by Meso Scale Discovery (MSD). For each visit, the geometric means (AU/mL) and 95% Confidence Interval (CI) is given.
Time frame: Endpoint is assessed from baseline (i.e. mean of the titers measured at the screening and visit 1 before the first study drug administration) to the last study visit (week 74), at weeks 0, 2, 8, 10, 24, 26, 36, 48, 50, 67 and 74.
Population: ITT population (i.e. all randomized subjects who received at least 1 dose of the study drug)
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 74 | 2791.9 AU/mL |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 2 | 4147.0 AU/mL |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 26 | 3890.0 AU/mL |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Baseline | 1553.4 AU/mL |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 10 | 9371.5 AU/mL |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 36 | 2709.4 AU/mL |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 24 | 2770.0 AU/mL |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 48 | 2287.7 AU/mL |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 8 | 4281.7 AU/mL |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 67 | 3219.8 AU/mL |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 50 | 7472.5 AU/mL |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 24 | 9446.6 AU/mL |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Baseline | 2515.4 AU/mL |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 50 | 13280.3 AU/mL |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 26 | 13142.7 AU/mL |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 74 | 8993.0 AU/mL |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 2 | 8245.3 AU/mL |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 36 | 12713.9 AU/mL |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 8 | 7928.5 AU/mL |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 67 | 8944.8 AU/mL |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 10 | 17848.1 AU/mL |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 48 | 9108.4 AU/mL |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 67 | 6180.6 AU/mL |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 26 | 8779.5 AU/mL |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 36 | 6886.6 AU/mL |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 50 | 8536.0 AU/mL |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 10 | 9317.6 AU/mL |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 24 | 6424.4 AU/mL |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 2 | 4132.5 AU/mL |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Baseline | 1691.8 AU/mL |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 8 | 3973.2 AU/mL |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 48 | 5886.6 AU/mL |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 74 | 5383.9 AU/mL |
| Cohort 1 Placebo | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 10 | 2099.3 AU/mL |
| Cohort 1 Placebo | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 36 | 2358.4 AU/mL |
| Cohort 1 Placebo | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Baseline | 2006.5 AU/mL |
| Cohort 1 Placebo | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 2 | 2270.6 AU/mL |
| Cohort 1 Placebo | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 74 | 2126.0 AU/mL |
| Cohort 1 Placebo | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 67 | 2080.4 AU/mL |
| Cohort 1 Placebo | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 8 | 1992.7 AU/mL |
| Cohort 1 Placebo | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 48 | 2254.2 AU/mL |
| Cohort 1 Placebo | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 50 | 2340.1 AU/mL |
| Cohort 1 Placebo | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 24 | 2381.2 AU/mL |
| Cohort 1 Placebo | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 26 | 2488.8 AU/mL |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 67 | 13077.0 AU/mL |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 48 | 7237.2 AU/mL |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Baseline | 2659.9 AU/mL |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 2 | 2419.2 AU/mL |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 8 | 2904.3 AU/mL |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 10 | 17874.8 AU/mL |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 24 | 6235.7 AU/mL |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 26 | 32099.1 AU/mL |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 36 | 14491.7 AU/mL |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 50 | 30248.2 AU/mL |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 74 | 10835.5 AU/mL |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 36 | 10543.9 AU/mL |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 26 | 17640.8 AU/mL |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 24 | 5275.9 AU/mL |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 74 | 6788.7 AU/mL |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 50 | 25491.5 AU/mL |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 10 | 13086.9 AU/mL |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 8 | 2270.4 AU/mL |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 2 | 2128.4 AU/mL |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 67 | 10082.0 AU/mL |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Baseline | 2027.6 AU/mL |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 48 | 6321.2 AU/mL |
| Cohort 2 Placebo | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 26 | 2174.3 AU/mL |
| Cohort 2 Placebo | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 2 | 2680.9 AU/mL |
| Cohort 2 Placebo | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 24 | 2128.9 AU/mL |
| Cohort 2 Placebo | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 74 | 2178.8 AU/mL |
| Cohort 2 Placebo | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 10 | 2497.6 AU/mL |
| Cohort 2 Placebo | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 67 | 2295.7 AU/mL |
| Cohort 2 Placebo | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Baseline | 2754.4 AU/mL |
| Cohort 2 Placebo | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 50 | 2436.9 AU/mL |
| Cohort 2 Placebo | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 36 | 2273.8 AU/mL |
| Cohort 2 Placebo | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 8 | 2682.9 AU/mL |
| Cohort 2 Placebo | Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 48 | 2213.5 AU/mL |
Primary
Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set
At all visits, blood was collected for the determination of the immune response in serum. Anti-phosphorylated Tau (pTau) IgG titers were measured by Meso Scale Discovery (MSD). For each visit, the geometric means (AU/mL) and 95% Confidence Interval (CI) is given.
Time frame: Endpoint is assessed from baseline (i.e. mean of the titers measured at the screening and visit 1 before the first study drug administration) to the last study visit (week 74), at weeks 0, 2, 8, 10, 24, 26, 36, 48, 50, 67 and 74.
Population: ITT population (i.e. all randomized subjects who received at least 1 dose of the study drug).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 10 | 110984.4 AU/mL |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 2 | 80292.0 AU/mL |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 26 | 21800.0 AU/mL |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 48 | 5408.4 AU/mL |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 24 | 6900.0 AU/mL |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 36 | 8207.3 AU/mL |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 67 | 14623.7 AU/mL |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 8 | 49360.9 AU/mL |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Baseline | 2048.4 AU/mL |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 74 | 10527.5 AU/mL |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 50 | 86662.7 AU/mL |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 50 | 54164.6 AU/mL |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 67 | 17464.2 AU/mL |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 2 | 158154.6 AU/mL |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Baseline | 994.6 AU/mL |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 48 | 17533.0 AU/mL |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 10 | 182111.4 AU/mL |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 8 | 92181.7 AU/mL |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 24 | 32248.7 AU/mL |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 26 | 71385.3 AU/mL |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 74 | 15301.0 AU/mL |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 36 | 30141.2 AU/mL |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 36 | 19810.7 AU/mL |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 26 | 60104.8 AU/mL |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 2 | 187980.6 AU/mL |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Baseline | 676.2 AU/mL |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 67 | 10128.3 AU/mL |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 8 | 66035.9 AU/mL |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 50 | 63735.9 AU/mL |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 10 | 135520.1 AU/mL |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 74 | 8565.4 AU/mL |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 48 | 10848.2 AU/mL |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 24 | 19853.3 AU/mL |
| Cohort 1 Placebo | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 26 | 1136.8 AU/mL |
| Cohort 1 Placebo | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Baseline | 802.4 AU/mL |
| Cohort 1 Placebo | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 2 | 811.0 AU/mL |
| Cohort 1 Placebo | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 8 | 768.6 AU/mL |
| Cohort 1 Placebo | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 10 | 749.7 AU/mL |
| Cohort 1 Placebo | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 24 | 1056.1 AU/mL |
| Cohort 1 Placebo | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 36 | 571.6 AU/mL |
| Cohort 1 Placebo | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 48 | 676.2 AU/mL |
| Cohort 1 Placebo | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 50 | 617.0 AU/mL |
| Cohort 1 Placebo | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 67 | 714.1 AU/mL |
| Cohort 1 Placebo | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 74 | 719.1 AU/mL |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 24 | 27519.3 AU/mL |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Baseline | 913.9 AU/mL |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 36 | 127585.6 AU/mL |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 10 | 105042.6 AU/mL |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 48 | 56549.1 AU/mL |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 8 | 3054.4 AU/mL |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 74 | 107038.5 AU/mL |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 50 | 408403.6 AU/mL |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 2 | 1403.8 AU/mL |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 67 | 144349.8 AU/mL |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 26 | 329361.3 AU/mL |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 48 | 25968.2 AU/mL |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 8 | 6928.5 AU/mL |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Baseline | 1073.3 AU/mL |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 24 | 27030.2 AU/mL |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 26 | 123787.7 AU/mL |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 50 | 137934.8 AU/mL |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 2 | 5286.1 AU/mL |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 74 | 31817.4 AU/mL |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 67 | 47764.4 AU/mL |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 36 | 58190.1 AU/mL |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 10 | 82513.4 AU/mL |
| Cohort 2 Placebo | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 67 | 681.2 AU/mL |
| Cohort 2 Placebo | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 8 | 971.5 AU/mL |
| Cohort 2 Placebo | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 24 | 789.4 AU/mL |
| Cohort 2 Placebo | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 74 | 682.9 AU/mL |
| Cohort 2 Placebo | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Baseline | 981.7 AU/mL |
| Cohort 2 Placebo | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 36 | 1245.1 AU/mL |
| Cohort 2 Placebo | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 10 | 969.2 AU/mL |
| Cohort 2 Placebo | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 50 | 1311.8 AU/mL |
| Cohort 2 Placebo | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 2 | 895.4 AU/mL |
| Cohort 2 Placebo | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 48 | 1137.1 AU/mL |
| Cohort 2 Placebo | Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 26 | 919.5 AU/mL |
Primary
Mean Change From Baseline in Body Temperature, ITT Set
At reported visits, body temperatures (°C = degree Celsius) were measured. A change from baseline value is defined as the value at post-baseline timepoint minus the baseline value, i.e. post-baseline value - baseline value
Time frame: Endpoint is assessed from baseline (i.e. last non-missing value prior to the first immunization at week 0) to the last study visit (week 74), at weeks 26, 50 and 74.
Population: ITT population (i.e. all randomized subjects who received at least 1 dose of the study drug).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Mean Change From Baseline in Body Temperature, ITT Set | Change from baseline to Week 74 | 0.08 °C | Standard Deviation 0.171 |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Mean Change From Baseline in Body Temperature, ITT Set | Change from baseline to Week 50 | 0.03 °C | Standard Deviation 0.299 |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Mean Change From Baseline in Body Temperature, ITT Set | Change from baseline to Week 26 | -0.40 °C | — |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Mean Change From Baseline in Body Temperature, ITT Set | Change from baseline to Week 50 | 0.18 °C | Standard Deviation 0.451 |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Mean Change From Baseline in Body Temperature, ITT Set | Change from baseline to Week 26 | 0.02 °C | Standard Deviation 0.617 |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Mean Change From Baseline in Body Temperature, ITT Set | Change from baseline to Week 74 | 0.13 °C | Standard Deviation 0.625 |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Mean Change From Baseline in Body Temperature, ITT Set | Change from baseline to Week 74 | -0.18 °C | Standard Deviation 0.383 |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Mean Change From Baseline in Body Temperature, ITT Set | Change from baseline to Week 26 | 0.03 °C | Standard Deviation 0.367 |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Mean Change From Baseline in Body Temperature, ITT Set | Change from baseline to Week 50 | -0.04 °C | Standard Deviation 0.532 |
| Cohort 1 Placebo | Mean Change From Baseline in Body Temperature, ITT Set | Change from baseline to Week 50 | 0.36 °C | Standard Deviation 0.357 |
| Cohort 1 Placebo | Mean Change From Baseline in Body Temperature, ITT Set | Change from baseline to Week 26 | 0.19 °C | Standard Deviation 0.36 |
| Cohort 1 Placebo | Mean Change From Baseline in Body Temperature, ITT Set | Change from baseline to Week 74 | 0.29 °C | Standard Deviation 0.623 |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Mean Change From Baseline in Body Temperature, ITT Set | Change from baseline to Week 50 | -0.08 °C | Standard Deviation 0.88 |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Mean Change From Baseline in Body Temperature, ITT Set | Change from baseline to Week 26 | 0.12 °C | Standard Deviation 0.781 |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Mean Change From Baseline in Body Temperature, ITT Set | Change from baseline to Week 74 | 0.00 °C | Standard Deviation 0.555 |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Mean Change From Baseline in Body Temperature, ITT Set | Change from baseline to Week 26 | 0.02 °C | Standard Deviation 0.462 |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Mean Change From Baseline in Body Temperature, ITT Set | Change from baseline to Week 74 | -0.35 °C | Standard Deviation 0.367 |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Mean Change From Baseline in Body Temperature, ITT Set | Change from baseline to Week 50 | -0.47 °C | Standard Deviation 0.266 |
| Cohort 2 Placebo | Mean Change From Baseline in Body Temperature, ITT Set | Change from baseline to Week 74 | 0.15 °C | Standard Deviation 0.436 |
| Cohort 2 Placebo | Mean Change From Baseline in Body Temperature, ITT Set | Change from baseline to Week 50 | 0.05 °C | Standard Deviation 0.635 |
| Cohort 2 Placebo | Mean Change From Baseline in Body Temperature, ITT Set | Change from baseline to Week 26 | 0.30 °C | Standard Deviation 0.497 |
Primary
Mean Change From Baseline in Diastolic Blood Pressure, ITT Set
At reported visits, diastolic blood pressures (mmHg = millimeter of mercury) were measured in sitting position only, after the subject has been sitting down for at least 5 minutes. A change from baseline value is defined as the value at post-baseline timepoint minus the baseline value, i.e. post-baseline value - baseline value
Time frame: Endpoint is assessed from baseline (i.e. last non-missing value prior to the first immunization at week 0) to the last study visit (week 74), at weeks 26, 50 and 74.
Population: ITT population (i.e. all randomized subjects who received at least 1 dose of the study drug).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Mean Change From Baseline in Diastolic Blood Pressure, ITT Set | Change from baseline to Week 74 | -3.75 mmHg | Standard Deviation 5.377 |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Mean Change From Baseline in Diastolic Blood Pressure, ITT Set | Change from baseline to Week 50 | -6.75 mmHg | Standard Deviation 2.5 |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Mean Change From Baseline in Diastolic Blood Pressure, ITT Set | Change from baseline to Week 26 | -6.00 mmHg | — |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Mean Change From Baseline in Diastolic Blood Pressure, ITT Set | Change from baseline to Week 50 | -0.33 mmHg | Standard Deviation 6.334 |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Mean Change From Baseline in Diastolic Blood Pressure, ITT Set | Change from baseline to Week 26 | 2.47 mmHg | Standard Deviation 8.79 |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Mean Change From Baseline in Diastolic Blood Pressure, ITT Set | Change from baseline to Week 74 | 4.76 mmHg | Standard Deviation 8.511 |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Mean Change From Baseline in Diastolic Blood Pressure, ITT Set | Change from baseline to Week 74 | 1.60 mmHg | Standard Deviation 5.857 |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Mean Change From Baseline in Diastolic Blood Pressure, ITT Set | Change from baseline to Week 26 | 3.67 mmHg | Standard Deviation 5.989 |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Mean Change From Baseline in Diastolic Blood Pressure, ITT Set | Change from baseline to Week 50 | 5.20 mmHg | Standard Deviation 9.203 |
| Cohort 1 Placebo | Mean Change From Baseline in Diastolic Blood Pressure, ITT Set | Change from baseline to Week 50 | -4.20 mmHg | Standard Deviation 6.713 |
| Cohort 1 Placebo | Mean Change From Baseline in Diastolic Blood Pressure, ITT Set | Change from baseline to Week 26 | 2.00 mmHg | Standard Deviation 7.578 |
| Cohort 1 Placebo | Mean Change From Baseline in Diastolic Blood Pressure, ITT Set | Change from baseline to Week 74 | 0.40 mmHg | Standard Deviation 7.412 |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Mean Change From Baseline in Diastolic Blood Pressure, ITT Set | Change from baseline to Week 50 | -1.83 mmHg | Standard Deviation 5.037 |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Mean Change From Baseline in Diastolic Blood Pressure, ITT Set | Change from baseline to Week 26 | -5.00 mmHg | Standard Deviation 3.795 |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Mean Change From Baseline in Diastolic Blood Pressure, ITT Set | Change from baseline to Week 74 | -3.33 mmHg | Standard Deviation 6.947 |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Mean Change From Baseline in Diastolic Blood Pressure, ITT Set | Change from baseline to Week 26 | -3.17 mmHg | Standard Deviation 7.627 |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Mean Change From Baseline in Diastolic Blood Pressure, ITT Set | Change from baseline to Week 74 | -3.33 mmHg | Standard Deviation 4.227 |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Mean Change From Baseline in Diastolic Blood Pressure, ITT Set | Change from baseline to Week 50 | -2.50 mmHg | Standard Deviation 5.167 |
| Cohort 2 Placebo | Mean Change From Baseline in Diastolic Blood Pressure, ITT Set | Change from baseline to Week 74 | -1.25 mmHg | Standard Deviation 11.325 |
| Cohort 2 Placebo | Mean Change From Baseline in Diastolic Blood Pressure, ITT Set | Change from baseline to Week 50 | -5.00 mmHg | Standard Deviation 8.602 |
| Cohort 2 Placebo | Mean Change From Baseline in Diastolic Blood Pressure, ITT Set | Change from baseline to Week 26 | -8.25 mmHg | Standard Deviation 14.5 |
Primary
Mean Change From Baseline in Heart Rate, ITT Set
At reported visits, heart rates (bpm = beats per minute) were measured in sitting position only, after the subject has been sitting down for at least 5 minutes. A change from baseline value is defined as the value at post-baseline timepoint minus the baseline value, i.e. post-baseline value - baseline value
Time frame: Endpoint is assessed from baseline (i.e. last non-missing value prior to the first immunization at week 0) to the last study visit (week 74), at weeks 26, 50 and 74.
Population: ITT population (i.e. all randomized subjects who received at least 1 dose of the study drug).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Mean Change From Baseline in Heart Rate, ITT Set | Change from baseline to Week 50 | -5.75 bpm | Standard Deviation 4.193 |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Mean Change From Baseline in Heart Rate, ITT Set | Change from baseline to Week 26 | -2.00 bpm | — |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Mean Change From Baseline in Heart Rate, ITT Set | Change from baseline to Week 74 | 2.25 bpm | Standard Deviation 6.752 |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Mean Change From Baseline in Heart Rate, ITT Set | Change from baseline to Week 74 | 1.41 bpm | Standard Deviation 8.675 |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Mean Change From Baseline in Heart Rate, ITT Set | Change from baseline to Week 50 | -2.61 bpm | Standard Deviation 7.935 |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Mean Change From Baseline in Heart Rate, ITT Set | Change from baseline to Week 26 | -4.11 bpm | Standard Deviation 9.225 |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Mean Change From Baseline in Heart Rate, ITT Set | Change from baseline to Week 26 | -1.17 bpm | Standard Deviation 9.948 |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Mean Change From Baseline in Heart Rate, ITT Set | Change from baseline to Week 50 | -2.80 bpm | Standard Deviation 7.596 |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Mean Change From Baseline in Heart Rate, ITT Set | Change from baseline to Week 74 | -7.40 bpm | Standard Deviation 7.232 |
| Cohort 1 Placebo | Mean Change From Baseline in Heart Rate, ITT Set | Change from baseline to Week 50 | -0.30 bpm | Standard Deviation 9.019 |
| Cohort 1 Placebo | Mean Change From Baseline in Heart Rate, ITT Set | Change from baseline to Week 26 | -4.38 bpm | Standard Deviation 11.649 |
| Cohort 1 Placebo | Mean Change From Baseline in Heart Rate, ITT Set | Change from baseline to Week 74 | 1.90 bpm | Standard Deviation 13.674 |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Mean Change From Baseline in Heart Rate, ITT Set | Change from baseline to Week 50 | -6.00 bpm | Standard Deviation 5.762 |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Mean Change From Baseline in Heart Rate, ITT Set | Change from baseline to Week 26 | -1.83 bpm | Standard Deviation 7.494 |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Mean Change From Baseline in Heart Rate, ITT Set | Change from baseline to Week 74 | -6.17 bpm | Standard Deviation 3.92 |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Mean Change From Baseline in Heart Rate, ITT Set | Change from baseline to Week 26 | -0.33 bpm | Standard Deviation 4.885 |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Mean Change From Baseline in Heart Rate, ITT Set | Change from baseline to Week 74 | -0.67 bpm | Standard Deviation 7.967 |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Mean Change From Baseline in Heart Rate, ITT Set | Change from baseline to Week 50 | -3.00 bpm | Standard Deviation 6.633 |
| Cohort 2 Placebo | Mean Change From Baseline in Heart Rate, ITT Set | Change from baseline to Week 74 | -10.25 bpm | Standard Deviation 14.728 |
| Cohort 2 Placebo | Mean Change From Baseline in Heart Rate, ITT Set | Change from baseline to Week 50 | -7.25 bpm | Standard Deviation 11.558 |
| Cohort 2 Placebo | Mean Change From Baseline in Heart Rate, ITT Set | Change from baseline to Week 26 | -10.00 bpm | Standard Deviation 11.888 |
Primary
Mean Change From Baseline in Systolic Blood Pressure, ITT Set
At reported visits, systolic blood pressures (mmHg = millimeter of mercury) were measured in sitting position only, after the subject has been sitting down for at least 5 minutes. A change from baseline value is defined as the value at post-baseline timepoint minus the baseline value, i.e. post-baseline value - baseline value
Time frame: Endpoint is assessed from baseline (i.e. last non-missing value prior to the first immunization at week 0) to the last study visit (week 74), at weeks 26, 50 and 74.
Population: ITT population (i.e. all randomized subjects who received at least 1 dose of the study drug).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Mean Change From Baseline in Systolic Blood Pressure, ITT Set | Change from baseline to Week 26 | -15.00 mmHg | — |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Mean Change From Baseline in Systolic Blood Pressure, ITT Set | Change from baseline to Week 50 | -5.25 mmHg | Standard Deviation 13.647 |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Mean Change From Baseline in Systolic Blood Pressure, ITT Set | Change from baseline to Week 74 | -3.75 mmHg | Standard Deviation 15.457 |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Mean Change From Baseline in Systolic Blood Pressure, ITT Set | Change from baseline to Week 74 | -1.00 mmHg | Standard Deviation 19.082 |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Mean Change From Baseline in Systolic Blood Pressure, ITT Set | Change from baseline to Week 26 | 4.11 mmHg | Standard Deviation 16.773 |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Mean Change From Baseline in Systolic Blood Pressure, ITT Set | Change from baseline to Week 50 | -1.83 mmHg | Standard Deviation 19.242 |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Mean Change From Baseline in Systolic Blood Pressure, ITT Set | Change from baseline to Week 74 | 6.60 mmHg | Standard Deviation 15.421 |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Mean Change From Baseline in Systolic Blood Pressure, ITT Set | Change from baseline to Week 26 | 9.33 mmHg | Standard Deviation 8.335 |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Mean Change From Baseline in Systolic Blood Pressure, ITT Set | Change from baseline to Week 50 | 9.20 mmHg | Standard Deviation 9.859 |
| Cohort 1 Placebo | Mean Change From Baseline in Systolic Blood Pressure, ITT Set | Change from baseline to Week 26 | 1.38 mmHg | Standard Deviation 11.388 |
| Cohort 1 Placebo | Mean Change From Baseline in Systolic Blood Pressure, ITT Set | Change from baseline to Week 50 | -2.50 mmHg | Standard Deviation 14.393 |
| Cohort 1 Placebo | Mean Change From Baseline in Systolic Blood Pressure, ITT Set | Change from baseline to Week 74 | -1.60 mmHg | Standard Deviation 21.035 |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Mean Change From Baseline in Systolic Blood Pressure, ITT Set | Change from baseline to Week 26 | -3.17 mmHg | Standard Deviation 9.411 |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Mean Change From Baseline in Systolic Blood Pressure, ITT Set | Change from baseline to Week 50 | 1.33 mmHg | Standard Deviation 17.535 |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Mean Change From Baseline in Systolic Blood Pressure, ITT Set | Change from baseline to Week 74 | 0.67 mmHg | Standard Deviation 17.014 |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Mean Change From Baseline in Systolic Blood Pressure, ITT Set | Change from baseline to Week 50 | 0.67 mmHg | Standard Deviation 5.574 |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Mean Change From Baseline in Systolic Blood Pressure, ITT Set | Change from baseline to Week 26 | 3.50 mmHg | Standard Deviation 8.55 |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Mean Change From Baseline in Systolic Blood Pressure, ITT Set | Change from baseline to Week 74 | -2.83 mmHg | Standard Deviation 7.195 |
| Cohort 2 Placebo | Mean Change From Baseline in Systolic Blood Pressure, ITT Set | Change from baseline to Week 26 | -3.75 mmHg | Standard Deviation 27.861 |
| Cohort 2 Placebo | Mean Change From Baseline in Systolic Blood Pressure, ITT Set | Change from baseline to Week 74 | 3.75 mmHg | Standard Deviation 27.208 |
| Cohort 2 Placebo | Mean Change From Baseline in Systolic Blood Pressure, ITT Set | Change from baseline to Week 50 | -1.75 mmHg | Standard Deviation 23.243 |
Primary
Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set
Suicidal ideation or behavior using Columbia-Suicide Severity Rating Scale (C-SSRS) was assessed at Baseline (screening or visit 1 (Week 0)) and at weeks 26, 50 and 74. A set of questions related to suicidal behavior or ideation was directly asked by the rater to the subject.
Time frame: Endpoint is assessed from baseline (i.e. last non-missing value prior to the first immunization at Visit 1 (Week 0) or Screening) to the last study visit (week 74), at weeks 26, 50 and 74.
Population: ITT population (i.e. all randomized subjects who received at least 1 dose of the study drug).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set | Suicidal ideation or behavior - Week 26 | No | 3 Participants |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set | Suicidal ideation or behavior - Baseline | Yes | 0 Participants |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set | Suicidal ideation or behavior - Baseline | No | 6 Participants |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set | Suicidal ideation or behavior - Week 26 | Yes | 0 Participants |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set | Suicidal ideation or behavior - Week 50 | No | 4 Participants |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set | Suicidal ideation or behavior - Week 50 | Yes | 0 Participants |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set | Suicidal ideation or behavior - Week 74 | No | 4 Participants |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set | Suicidal ideation or behavior - Week 74 | Yes | 0 Participants |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set | Suicidal ideation or behavior - Baseline | Yes | 0 Participants |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set | Suicidal ideation or behavior - Week 74 | Yes | 0 Participants |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set | Suicidal ideation or behavior - Week 26 | No | 19 Participants |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set | Suicidal ideation or behavior - Week 26 | Yes | 0 Participants |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set | Suicidal ideation or behavior - Week 50 | No | 18 Participants |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set | Suicidal ideation or behavior - Week 50 | Yes | 0 Participants |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set | Suicidal ideation or behavior - Week 74 | No | 17 Participants |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set | Suicidal ideation or behavior - Baseline | No | 19 Participants |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set | Suicidal ideation or behavior - Week 26 | No | 6 Participants |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set | Suicidal ideation or behavior - Week 74 | Yes | 0 Participants |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set | Suicidal ideation or behavior - Week 26 | Yes | 0 Participants |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set | Suicidal ideation or behavior - Week 50 | No | 5 Participants |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set | Suicidal ideation or behavior - Week 50 | Yes | 0 Participants |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set | Suicidal ideation or behavior - Week 74 | No | 5 Participants |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set | Suicidal ideation or behavior - Baseline | Yes | 0 Participants |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set | Suicidal ideation or behavior - Baseline | No | 6 Participants |
| Cohort 1 Placebo | Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set | Suicidal ideation or behavior - Week 26 | Yes | 0 Participants |
| Cohort 1 Placebo | Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set | Suicidal ideation or behavior - Week 74 | Yes | 0 Participants |
| Cohort 1 Placebo | Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set | Suicidal ideation or behavior - Week 50 | No | 10 Participants |
| Cohort 1 Placebo | Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set | Suicidal ideation or behavior - Week 50 | Yes | 0 Participants |
| Cohort 1 Placebo | Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set | Suicidal ideation or behavior - Week 74 | No | 10 Participants |
| Cohort 1 Placebo | Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set | Suicidal ideation or behavior - Week 26 | No | 10 Participants |
| Cohort 1 Placebo | Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set | Suicidal ideation or behavior - Baseline | No | 10 Participants |
| Cohort 1 Placebo | Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set | Suicidal ideation or behavior - Baseline | Yes | 0 Participants |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set | Suicidal ideation or behavior - Week 50 | No | 5 Participants |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set | Suicidal ideation or behavior - Week 74 | Yes | 0 Participants |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set | Suicidal ideation or behavior - Week 50 | Yes | 1 Participants |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set | Suicidal ideation or behavior - Week 74 | No | 6 Participants |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set | Suicidal ideation or behavior - Week 26 | Yes | 0 Participants |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set | Suicidal ideation or behavior - Baseline | No | 6 Participants |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set | Suicidal ideation or behavior - Baseline | Yes | 0 Participants |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set | Suicidal ideation or behavior - Week 26 | No | 6 Participants |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set | Suicidal ideation or behavior - Week 50 | Yes | 0 Participants |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set | Suicidal ideation or behavior - Week 74 | Yes | 0 Participants |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set | Suicidal ideation or behavior - Week 74 | No | 6 Participants |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set | Suicidal ideation or behavior - Week 50 | No | 6 Participants |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set | Suicidal ideation or behavior - Baseline | No | 6 Participants |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set | Suicidal ideation or behavior - Baseline | Yes | 0 Participants |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set | Suicidal ideation or behavior - Week 26 | No | 6 Participants |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set | Suicidal ideation or behavior - Week 26 | Yes | 0 Participants |
| Cohort 2 Placebo | Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set | Suicidal ideation or behavior - Week 74 | No | 4 Participants |
| Cohort 2 Placebo | Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set | Suicidal ideation or behavior - Week 50 | Yes | 0 Participants |
| Cohort 2 Placebo | Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set | Suicidal ideation or behavior - Week 74 | Yes | 0 Participants |
| Cohort 2 Placebo | Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set | Suicidal ideation or behavior - Baseline | No | 4 Participants |
| Cohort 2 Placebo | Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set | Suicidal ideation or behavior - Baseline | Yes | 0 Participants |
| Cohort 2 Placebo | Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set | Suicidal ideation or behavior - Week 26 | No | 4 Participants |
| Cohort 2 Placebo | Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set | Suicidal ideation or behavior - Week 26 | Yes | 0 Participants |
| Cohort 2 Placebo | Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set | Suicidal ideation or behavior - Week 50 | No | 4 Participants |
Primary
Number of Participants With Abnormal MRI Results, ITT Set
Brain MRI scans were conducted according to the schedule of assessments, i.e. at Baseline (screening) and at weeks 10, 26, 50, 74 and examined for evidence of brain pathology. Normal, abnormal not clinically significant (NCS) and abnormal clinically significant (CS) results as interpreted by the clinical site are reported.
Time frame: Endpoint is assessed from baseline (screening) to the last study visit (week 74), at weeks 10, 26, 50 and 74.
Population: ITT population (i.e. all randomized subjects who received at least 1 dose of the study drug).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 74 | Abnormal CS | 0 Participants |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 26 | Abnormal NCS | 0 Participants |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 26 | Not evaluable | 0 Participants |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 26 | Abnormal CS | 0 Participants |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 50 | Normal | 4 Participants |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Baseline | Abnormal CS | 0 Participants |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Baseline | Not evaluable | 0 Participants |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Baseline | Normal | 5 Participants |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 74 | Abnormal NCS | 0 Participants |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 10 | Normal | 6 Participants |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 74 | Normal | 3 Participants |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 10 | Abnormal NCS | 0 Participants |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 50 | Not evaluable | 0 Participants |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 10 | Abnormal CS | 0 Participants |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 74 | Not evaluable | 0 Participants |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 50 | Abnormal CS | 0 Participants |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 10 | Not evaluable | 0 Participants |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Baseline | Abnormal NCS | 1 Participants |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 50 | Abnormal NCS | 0 Participants |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 26 | Normal | 1 Participants |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 74 | Normal | 15 Participants |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Baseline | Abnormal NCS | 2 Participants |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 26 | Not evaluable | 0 Participants |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 50 | Abnormal CS | 0 Participants |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 26 | Abnormal NCS | 2 Participants |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 10 | Normal | 16 Participants |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 74 | Abnormal NCS | 2 Participants |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 10 | Not evaluable | 1 Participants |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 50 | Normal | 17 Participants |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 26 | Abnormal CS | 0 Participants |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 10 | Abnormal CS | 0 Participants |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Baseline | Normal | 17 Participants |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 50 | Not evaluable | 0 Participants |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 74 | Abnormal CS | 0 Participants |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 50 | Abnormal NCS | 1 Participants |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 10 | Abnormal NCS | 2 Participants |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Baseline | Abnormal CS | 0 Participants |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Baseline | Not evaluable | 0 Participants |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 74 | Not evaluable | 0 Participants |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 26 | Normal | 17 Participants |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 10 | Normal | 6 Participants |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Baseline | Not evaluable | 0 Participants |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 50 | Abnormal NCS | 0 Participants |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 74 | Normal | 5 Participants |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 74 | Not evaluable | 0 Participants |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 50 | Not evaluable | 0 Participants |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 10 | Not evaluable | 0 Participants |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 10 | Abnormal NCS | 0 Participants |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 50 | Abnormal CS | 0 Participants |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 26 | Not evaluable | 0 Participants |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 26 | Abnormal NCS | 0 Participants |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Baseline | Abnormal NCS | 0 Participants |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 26 | Normal | 6 Participants |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 26 | Abnormal CS | 0 Participants |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 74 | Abnormal CS | 0 Participants |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 10 | Abnormal CS | 0 Participants |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 50 | Normal | 5 Participants |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Baseline | Abnormal CS | 0 Participants |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Baseline | Normal | 6 Participants |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 74 | Abnormal NCS | 0 Participants |
| Cohort 1 Placebo | Number of Participants With Abnormal MRI Results, ITT Set | Week 74 | Abnormal NCS | 0 Participants |
| Cohort 1 Placebo | Number of Participants With Abnormal MRI Results, ITT Set | Baseline | Normal | 10 Participants |
| Cohort 1 Placebo | Number of Participants With Abnormal MRI Results, ITT Set | Baseline | Abnormal NCS | 0 Participants |
| Cohort 1 Placebo | Number of Participants With Abnormal MRI Results, ITT Set | Baseline | Abnormal CS | 0 Participants |
| Cohort 1 Placebo | Number of Participants With Abnormal MRI Results, ITT Set | Baseline | Not evaluable | 0 Participants |
| Cohort 1 Placebo | Number of Participants With Abnormal MRI Results, ITT Set | Week 10 | Normal | 10 Participants |
| Cohort 1 Placebo | Number of Participants With Abnormal MRI Results, ITT Set | Week 10 | Abnormal NCS | 0 Participants |
| Cohort 1 Placebo | Number of Participants With Abnormal MRI Results, ITT Set | Week 10 | Abnormal CS | 0 Participants |
| Cohort 1 Placebo | Number of Participants With Abnormal MRI Results, ITT Set | Week 10 | Not evaluable | 0 Participants |
| Cohort 1 Placebo | Number of Participants With Abnormal MRI Results, ITT Set | Week 26 | Normal | 7 Participants |
| Cohort 1 Placebo | Number of Participants With Abnormal MRI Results, ITT Set | Week 26 | Abnormal NCS | 0 Participants |
| Cohort 1 Placebo | Number of Participants With Abnormal MRI Results, ITT Set | Week 26 | Abnormal CS | 0 Participants |
| Cohort 1 Placebo | Number of Participants With Abnormal MRI Results, ITT Set | Week 26 | Not evaluable | 1 Participants |
| Cohort 1 Placebo | Number of Participants With Abnormal MRI Results, ITT Set | Week 50 | Normal | 10 Participants |
| Cohort 1 Placebo | Number of Participants With Abnormal MRI Results, ITT Set | Week 50 | Abnormal NCS | 0 Participants |
| Cohort 1 Placebo | Number of Participants With Abnormal MRI Results, ITT Set | Week 50 | Abnormal CS | 0 Participants |
| Cohort 1 Placebo | Number of Participants With Abnormal MRI Results, ITT Set | Week 50 | Not evaluable | 0 Participants |
| Cohort 1 Placebo | Number of Participants With Abnormal MRI Results, ITT Set | Week 74 | Normal | 10 Participants |
| Cohort 1 Placebo | Number of Participants With Abnormal MRI Results, ITT Set | Week 74 | Abnormal CS | 0 Participants |
| Cohort 1 Placebo | Number of Participants With Abnormal MRI Results, ITT Set | Week 74 | Not evaluable | 0 Participants |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 74 | Abnormal CS | 0 Participants |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Baseline | Normal | 5 Participants |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 50 | Abnormal CS | 0 Participants |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 50 | Normal | 6 Participants |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 74 | Normal | 6 Participants |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 10 | Abnormal NCS | 0 Participants |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 74 | Not evaluable | 0 Participants |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 26 | Abnormal NCS | 0 Participants |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 10 | Normal | 6 Participants |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 50 | Not evaluable | 0 Participants |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Baseline | Abnormal NCS | 1 Participants |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 10 | Not evaluable | 0 Participants |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 74 | Abnormal NCS | 0 Participants |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 26 | Normal | 6 Participants |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 26 | Abnormal CS | 0 Participants |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 50 | Abnormal NCS | 0 Participants |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 26 | Not evaluable | 0 Participants |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Baseline | Abnormal CS | 0 Participants |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 10 | Abnormal CS | 0 Participants |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Baseline | Not evaluable | 0 Participants |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 26 | Normal | 6 Participants |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 26 | Not evaluable | 0 Participants |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 10 | Not evaluable | 0 Participants |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 50 | Normal | 5 Participants |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 10 | Abnormal CS | 0 Participants |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Baseline | Normal | 6 Participants |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 50 | Abnormal NCS | 1 Participants |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 10 | Abnormal NCS | 0 Participants |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 50 | Abnormal CS | 0 Participants |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 10 | Normal | 6 Participants |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 50 | Not evaluable | 0 Participants |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Baseline | Not evaluable | 0 Participants |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 74 | Normal | 4 Participants |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Baseline | Abnormal CS | 0 Participants |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 74 | Abnormal NCS | 2 Participants |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Baseline | Abnormal NCS | 0 Participants |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 74 | Not evaluable | 0 Participants |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 26 | Abnormal NCS | 0 Participants |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 74 | Abnormal CS | 0 Participants |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Number of Participants With Abnormal MRI Results, ITT Set | Week 26 | Abnormal CS | 0 Participants |
| Cohort 2 Placebo | Number of Participants With Abnormal MRI Results, ITT Set | Baseline | Abnormal CS | 0 Participants |
| Cohort 2 Placebo | Number of Participants With Abnormal MRI Results, ITT Set | Week 26 | Normal | 4 Participants |
| Cohort 2 Placebo | Number of Participants With Abnormal MRI Results, ITT Set | Week 50 | Abnormal NCS | 0 Participants |
| Cohort 2 Placebo | Number of Participants With Abnormal MRI Results, ITT Set | Week 10 | Abnormal CS | 0 Participants |
| Cohort 2 Placebo | Number of Participants With Abnormal MRI Results, ITT Set | Week 10 | Not evaluable | 0 Participants |
| Cohort 2 Placebo | Number of Participants With Abnormal MRI Results, ITT Set | Week 74 | Abnormal NCS | 1 Participants |
| Cohort 2 Placebo | Number of Participants With Abnormal MRI Results, ITT Set | Baseline | Abnormal NCS | 0 Participants |
| Cohort 2 Placebo | Number of Participants With Abnormal MRI Results, ITT Set | Week 74 | Abnormal CS | 0 Participants |
| Cohort 2 Placebo | Number of Participants With Abnormal MRI Results, ITT Set | Week 50 | Normal | 4 Participants |
| Cohort 2 Placebo | Number of Participants With Abnormal MRI Results, ITT Set | Week 26 | Abnormal CS | 0 Participants |
| Cohort 2 Placebo | Number of Participants With Abnormal MRI Results, ITT Set | Baseline | Normal | 4 Participants |
| Cohort 2 Placebo | Number of Participants With Abnormal MRI Results, ITT Set | Week 50 | Not evaluable | 0 Participants |
| Cohort 2 Placebo | Number of Participants With Abnormal MRI Results, ITT Set | Week 74 | Not evaluable | 0 Participants |
| Cohort 2 Placebo | Number of Participants With Abnormal MRI Results, ITT Set | Baseline | Not evaluable | 0 Participants |
| Cohort 2 Placebo | Number of Participants With Abnormal MRI Results, ITT Set | Week 26 | Abnormal NCS | 0 Participants |
| Cohort 2 Placebo | Number of Participants With Abnormal MRI Results, ITT Set | Week 10 | Normal | 4 Participants |
| Cohort 2 Placebo | Number of Participants With Abnormal MRI Results, ITT Set | Week 50 | Abnormal CS | 0 Participants |
| Cohort 2 Placebo | Number of Participants With Abnormal MRI Results, ITT Set | Week 26 | Not evaluable | 0 Participants |
| Cohort 2 Placebo | Number of Participants With Abnormal MRI Results, ITT Set | Week 74 | Normal | 3 Participants |
| Cohort 2 Placebo | Number of Participants With Abnormal MRI Results, ITT Set | Week 10 | Abnormal NCS | 0 Participants |
Primary
Overview of Treatment-Emergent Adverse Events Assessed by Intensity, Safety Set
Categorical data are presented with the number of subjects with at least one Treatment-Emergent Adverse Event (TEAE) assessed as: * Mild: Easily tolerated and causes minimal discomfort and does not interfere with everyday activities. * Moderate: Sufficiently discomforting to interfere with normal everyday activities; intervention may be needed. Event is not hazardous to the subject's health * Severe: Prevents normal everyday activities; treatment or other intervention usually needed. Hazard to the subject's health Although subjects may have experienced multiple events, they are included only once, in the maximum severity category
Time frame: Between the first dosing and the last study visit (week 74)
Population: Observations are given for the Safety population (all randomized subjects who received at least one dose of the study drug, analyzed based on the study treatment actually received). All 57 subjects randomized in the study received at least 1 dose of the study drug according to their randomized treatment and are therefore all included.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Overview of Treatment-Emergent Adverse Events Assessed by Intensity, Safety Set | Severe | 1 Participants |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Overview of Treatment-Emergent Adverse Events Assessed by Intensity, Safety Set | Moderate | 3 Participants |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Overview of Treatment-Emergent Adverse Events Assessed by Intensity, Safety Set | Mild | 2 Participants |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Overview of Treatment-Emergent Adverse Events Assessed by Intensity, Safety Set | Moderate | 7 Participants |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Overview of Treatment-Emergent Adverse Events Assessed by Intensity, Safety Set | Mild | 8 Participants |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Overview of Treatment-Emergent Adverse Events Assessed by Intensity, Safety Set | Severe | 2 Participants |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Overview of Treatment-Emergent Adverse Events Assessed by Intensity, Safety Set | Severe | 0 Participants |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Overview of Treatment-Emergent Adverse Events Assessed by Intensity, Safety Set | Mild | 3 Participants |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Overview of Treatment-Emergent Adverse Events Assessed by Intensity, Safety Set | Moderate | 3 Participants |
| Cohort 1 Placebo | Overview of Treatment-Emergent Adverse Events Assessed by Intensity, Safety Set | Moderate | 4 Participants |
| Cohort 1 Placebo | Overview of Treatment-Emergent Adverse Events Assessed by Intensity, Safety Set | Mild | 4 Participants |
| Cohort 1 Placebo | Overview of Treatment-Emergent Adverse Events Assessed by Intensity, Safety Set | Severe | 0 Participants |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Overview of Treatment-Emergent Adverse Events Assessed by Intensity, Safety Set | Moderate | 3 Participants |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Overview of Treatment-Emergent Adverse Events Assessed by Intensity, Safety Set | Mild | 3 Participants |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Overview of Treatment-Emergent Adverse Events Assessed by Intensity, Safety Set | Severe | 0 Participants |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Overview of Treatment-Emergent Adverse Events Assessed by Intensity, Safety Set | Mild | 1 Participants |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Overview of Treatment-Emergent Adverse Events Assessed by Intensity, Safety Set | Severe | 0 Participants |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Overview of Treatment-Emergent Adverse Events Assessed by Intensity, Safety Set | Moderate | 5 Participants |
| Cohort 2 Placebo | Overview of Treatment-Emergent Adverse Events Assessed by Intensity, Safety Set | Severe | 1 Participants |
| Cohort 2 Placebo | Overview of Treatment-Emergent Adverse Events Assessed by Intensity, Safety Set | Moderate | 1 Participants |
| Cohort 2 Placebo | Overview of Treatment-Emergent Adverse Events Assessed by Intensity, Safety Set | Mild | 2 Participants |
Primary
Overview of Treatment-Emergent Adverse Events Assessed by Relationship to Study Drug, Safety Set
Categorical data are presented with the number of subjects with at least one Treatment-Emergent Adverse Event (TEAE) assessed as: * Unrelated: Events reported as unrelated or unlikely related to study drug * Related: Events reported as possibly related or probably related to study drug Although subjects may have experienced multiple events, they are included only once, in the strongest relationship category
Time frame: Between the first dosing and the last study visit (week 74)
Population: Observations are given for the Safety population (all randomized subjects who received at least one dose of the study drug, analyzed based on the study treatment actually received). All 57 subjects randomized in the study received at least 1 dose of the study drug according to their randomized treatment and are therefore all included.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Overview of Treatment-Emergent Adverse Events Assessed by Relationship to Study Drug, Safety Set | Unrelated | 3 Participants |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Overview of Treatment-Emergent Adverse Events Assessed by Relationship to Study Drug, Safety Set | Related | 3 Participants |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Overview of Treatment-Emergent Adverse Events Assessed by Relationship to Study Drug, Safety Set | Unrelated | 2 Participants |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Overview of Treatment-Emergent Adverse Events Assessed by Relationship to Study Drug, Safety Set | Related | 15 Participants |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Overview of Treatment-Emergent Adverse Events Assessed by Relationship to Study Drug, Safety Set | Unrelated | 0 Participants |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Overview of Treatment-Emergent Adverse Events Assessed by Relationship to Study Drug, Safety Set | Related | 6 Participants |
| Cohort 1 Placebo | Overview of Treatment-Emergent Adverse Events Assessed by Relationship to Study Drug, Safety Set | Unrelated | 6 Participants |
| Cohort 1 Placebo | Overview of Treatment-Emergent Adverse Events Assessed by Relationship to Study Drug, Safety Set | Related | 2 Participants |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Overview of Treatment-Emergent Adverse Events Assessed by Relationship to Study Drug, Safety Set | Unrelated | 2 Participants |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Overview of Treatment-Emergent Adverse Events Assessed by Relationship to Study Drug, Safety Set | Related | 4 Participants |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Overview of Treatment-Emergent Adverse Events Assessed by Relationship to Study Drug, Safety Set | Unrelated | 4 Participants |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Overview of Treatment-Emergent Adverse Events Assessed by Relationship to Study Drug, Safety Set | Related | 2 Participants |
| Cohort 2 Placebo | Overview of Treatment-Emergent Adverse Events Assessed by Relationship to Study Drug, Safety Set | Unrelated | 4 Participants |
| Cohort 2 Placebo | Overview of Treatment-Emergent Adverse Events Assessed by Relationship to Study Drug, Safety Set | Related | 0 Participants |
Primary
Overview of Treatment-Emergent Adverse Events, Safety Set
Categorical data are presented with the number of subjects with at least one event for the defined categories. Subjects are included only once, even if they experienced multiple events in a category.
Time frame: AEs falling between first dosing (week 0) and last study visit (week 74), ie up to 74 weeks, defined as Treatment-Emergent Adverse Events (TEAEs)
Population: Observations are given for the Safety population (all randomized subjects who received at least one dose of the study drug, analyzed based on the study treatment actually received). All 57 subjects randomized in the study received at least 1 dose of the study drug according to their randomized treatment and are therefore all included in the Safety population, which is identical to the Intention-to Treat (ITT) population (all randomized subjects who received at least one dose of the study drug).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Overview of Treatment-Emergent Adverse Events, Safety Set | Any Severe TEAE | 1 Participants |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Overview of Treatment-Emergent Adverse Events, Safety Set | Any TEAE Leading to Study Drug Discontinuation | 0 Participants |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Overview of Treatment-Emergent Adverse Events, Safety Set | Any TEAE Leading to Study Discontinuation | 0 Participants |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Overview of Treatment-Emergent Adverse Events, Safety Set | Any Adverse Drug Reactions | 3 Participants |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Overview of Treatment-Emergent Adverse Events, Safety Set | Any TEAE | 6 Participants |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Overview of Treatment-Emergent Adverse Events, Safety Set | Any Serious TEAE | 2 Participants |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Overview of Treatment-Emergent Adverse Events, Safety Set | Any TEAE with Outcome of Death | 0 Participants |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Overview of Treatment-Emergent Adverse Events, Safety Set | Any Serious Adverse Drug Reactions | 0 Participants |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Overview of Treatment-Emergent Adverse Events, Safety Set | Any TEAE Leading to Study Discontinuation | 0 Participants |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Overview of Treatment-Emergent Adverse Events, Safety Set | Any Serious TEAE | 2 Participants |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Overview of Treatment-Emergent Adverse Events, Safety Set | Any Adverse Drug Reactions | 15 Participants |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Overview of Treatment-Emergent Adverse Events, Safety Set | Any TEAE Leading to Study Drug Discontinuation | 0 Participants |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Overview of Treatment-Emergent Adverse Events, Safety Set | Any TEAE | 17 Participants |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Overview of Treatment-Emergent Adverse Events, Safety Set | Any Serious Adverse Drug Reactions | 1 Participants |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Overview of Treatment-Emergent Adverse Events, Safety Set | Any Severe TEAE | 2 Participants |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Overview of Treatment-Emergent Adverse Events, Safety Set | Any TEAE with Outcome of Death | 0 Participants |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Overview of Treatment-Emergent Adverse Events, Safety Set | Any Serious Adverse Drug Reactions | 0 Participants |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Overview of Treatment-Emergent Adverse Events, Safety Set | Any TEAE Leading to Study Drug Discontinuation | 0 Participants |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Overview of Treatment-Emergent Adverse Events, Safety Set | Any TEAE Leading to Study Discontinuation | 0 Participants |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Overview of Treatment-Emergent Adverse Events, Safety Set | Any Serious TEAE | 2 Participants |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Overview of Treatment-Emergent Adverse Events, Safety Set | Any Severe TEAE | 0 Participants |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Overview of Treatment-Emergent Adverse Events, Safety Set | Any TEAE with Outcome of Death | 0 Participants |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Overview of Treatment-Emergent Adverse Events, Safety Set | Any TEAE | 6 Participants |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Overview of Treatment-Emergent Adverse Events, Safety Set | Any Adverse Drug Reactions | 6 Participants |
| Cohort 1 Placebo | Overview of Treatment-Emergent Adverse Events, Safety Set | Any Serious Adverse Drug Reactions | 0 Participants |
| Cohort 1 Placebo | Overview of Treatment-Emergent Adverse Events, Safety Set | Any Adverse Drug Reactions | 2 Participants |
| Cohort 1 Placebo | Overview of Treatment-Emergent Adverse Events, Safety Set | Any TEAE with Outcome of Death | 0 Participants |
| Cohort 1 Placebo | Overview of Treatment-Emergent Adverse Events, Safety Set | Any TEAE Leading to Study Drug Discontinuation | 0 Participants |
| Cohort 1 Placebo | Overview of Treatment-Emergent Adverse Events, Safety Set | Any TEAE | 8 Participants |
| Cohort 1 Placebo | Overview of Treatment-Emergent Adverse Events, Safety Set | Any Serious TEAE | 0 Participants |
| Cohort 1 Placebo | Overview of Treatment-Emergent Adverse Events, Safety Set | Any TEAE Leading to Study Discontinuation | 0 Participants |
| Cohort 1 Placebo | Overview of Treatment-Emergent Adverse Events, Safety Set | Any Severe TEAE | 0 Participants |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Overview of Treatment-Emergent Adverse Events, Safety Set | Any TEAE Leading to Study Discontinuation | 0 Participants |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Overview of Treatment-Emergent Adverse Events, Safety Set | Any TEAE with Outcome of Death | 0 Participants |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Overview of Treatment-Emergent Adverse Events, Safety Set | Any Serious TEAE | 0 Participants |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Overview of Treatment-Emergent Adverse Events, Safety Set | Any Severe TEAE | 0 Participants |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Overview of Treatment-Emergent Adverse Events, Safety Set | Any Adverse Drug Reactions | 4 Participants |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Overview of Treatment-Emergent Adverse Events, Safety Set | Any Serious Adverse Drug Reactions | 0 Participants |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Overview of Treatment-Emergent Adverse Events, Safety Set | Any TEAE Leading to Study Drug Discontinuation | 0 Participants |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Overview of Treatment-Emergent Adverse Events, Safety Set | Any TEAE | 6 Participants |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Overview of Treatment-Emergent Adverse Events, Safety Set | Any TEAE | 6 Participants |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Overview of Treatment-Emergent Adverse Events, Safety Set | Any TEAE Leading to Study Drug Discontinuation | 0 Participants |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Overview of Treatment-Emergent Adverse Events, Safety Set | Any TEAE Leading to Study Discontinuation | 0 Participants |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Overview of Treatment-Emergent Adverse Events, Safety Set | Any Severe TEAE | 0 Participants |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Overview of Treatment-Emergent Adverse Events, Safety Set | Any Serious TEAE | 0 Participants |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Overview of Treatment-Emergent Adverse Events, Safety Set | Any TEAE with Outcome of Death | 0 Participants |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Overview of Treatment-Emergent Adverse Events, Safety Set | Any Serious Adverse Drug Reactions | 0 Participants |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Overview of Treatment-Emergent Adverse Events, Safety Set | Any Adverse Drug Reactions | 2 Participants |
| Cohort 2 Placebo | Overview of Treatment-Emergent Adverse Events, Safety Set | Any Serious Adverse Drug Reactions | 0 Participants |
| Cohort 2 Placebo | Overview of Treatment-Emergent Adverse Events, Safety Set | Any TEAE | 4 Participants |
| Cohort 2 Placebo | Overview of Treatment-Emergent Adverse Events, Safety Set | Any Serious TEAE | 1 Participants |
| Cohort 2 Placebo | Overview of Treatment-Emergent Adverse Events, Safety Set | Any Severe TEAE | 1 Participants |
| Cohort 2 Placebo | Overview of Treatment-Emergent Adverse Events, Safety Set | Any Adverse Drug Reactions | 0 Participants |
| Cohort 2 Placebo | Overview of Treatment-Emergent Adverse Events, Safety Set | Any TEAE Leading to Study Drug Discontinuation | 0 Participants |
| Cohort 2 Placebo | Overview of Treatment-Emergent Adverse Events, Safety Set | Any TEAE Leading to Study Discontinuation | 0 Participants |
| Cohort 2 Placebo | Overview of Treatment-Emergent Adverse Events, Safety Set | Any TEAE with Outcome of Death | 0 Participants |
Secondary
Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set
At all visits, blood was collected for the determination of the immune response in serum. Anti-phosphorylated Tau (pTau) IgM titers were measured by enzyme-linked immunosorbent assay (ELISA). For each visit, the geometric means (AU/mL) and 95% Confidence Interval (CI) is given.
Time frame: Endpoint is assessed from baseline (i.e. mean of the titers measured at the screening and visit 1 before the first study drug administration) to the last study visit (week 74), at weeks 0, 2, 8, 10, 24, 26, 36, 48, 50, 67 and 74.
Population: ITT population (i.e. all randomized subjects who received at least 1 dose of the study drug).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 50 | 4714.6 AU/mL |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 8 | 3666.8 AU/mL |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 48 | 802.9 AU/mL |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 67 | 1858.5 AU/mL |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 24 | 696.0 AU/mL |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Baseline | 355.3 AU/mL |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 2 | 25951.9 AU/mL |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 10 | 4436.9 AU/mL |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 26 | 2830.0 AU/mL |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 74 | 1785.9 AU/mL |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 36 | 806.2 AU/mL |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 36 | 2958.8 AU/mL |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 26 | 5137.1 AU/mL |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 2 | 15563.7 AU/mL |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 67 | 1898.6 AU/mL |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 48 | 1789.3 AU/mL |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 50 | 5214.3 AU/mL |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 74 | 1509.7 AU/mL |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Baseline | 154.8 AU/mL |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 8 | 3439.4 AU/mL |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 10 | 4792.5 AU/mL |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 24 | 1967.4 AU/mL |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 24 | 2758.4 AU/mL |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 74 | 3880.2 AU/mL |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 26 | 7950.1 AU/mL |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 10 | 7672.5 AU/mL |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 8 | 4936.6 AU/mL |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 36 | 2906.2 AU/mL |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 48 | 2362.7 AU/mL |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 2 | 20464.3 AU/mL |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 50 | 8509.3 AU/mL |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 67 | 4539.9 AU/mL |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Baseline | 368.6 AU/mL |
| Cohort 1 Placebo | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 26 | 334.8 AU/mL |
| Cohort 1 Placebo | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 67 | 431.9 AU/mL |
| Cohort 1 Placebo | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 50 | 318.9 AU/mL |
| Cohort 1 Placebo | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 8 | 274.9 AU/mL |
| Cohort 1 Placebo | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 10 | 288.5 AU/mL |
| Cohort 1 Placebo | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Baseline | 297.5 AU/mL |
| Cohort 1 Placebo | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 24 | 345.0 AU/mL |
| Cohort 1 Placebo | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 48 | 310.9 AU/mL |
| Cohort 1 Placebo | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 74 | 343.0 AU/mL |
| Cohort 1 Placebo | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 2 | 297.5 AU/mL |
| Cohort 1 Placebo | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 36 | 308.2 AU/mL |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 48 | 368.6 AU/mL |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 24 | 473.9 AU/mL |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 26 | 483.3 AU/mL |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 36 | 356.1 AU/mL |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 10 | 564.7 AU/mL |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 50 | 360.5 AU/mL |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 67 | 393.7 AU/mL |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 74 | 449.9 AU/mL |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Baseline | 337.3 AU/mL |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 2 | 494.9 AU/mL |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 8 | 476.8 AU/mL |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 67 | 240.5 AU/mL |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 74 | 252.9 AU/mL |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Baseline | 147.1 AU/mL |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 50 | 248.8 AU/mL |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 48 | 297.6 AU/mL |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 2 | 327.4 AU/mL |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 36 | 329.0 AU/mL |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 26 | 153.5 AU/mL |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 10 | 349.6 AU/mL |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 8 | 276.8 AU/mL |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 24 | 202.6 AU/mL |
| Cohort 2 Placebo | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 8 | 217.4 AU/mL |
| Cohort 2 Placebo | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 26 | 181.8 AU/mL |
| Cohort 2 Placebo | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 50 | 275.0 AU/mL |
| Cohort 2 Placebo | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Baseline | 248.5 AU/mL |
| Cohort 2 Placebo | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 24 | 183.3 AU/mL |
| Cohort 2 Placebo | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 48 | 278.1 AU/mL |
| Cohort 2 Placebo | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 74 | 348.0 AU/mL |
| Cohort 2 Placebo | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 36 | 265.4 AU/mL |
| Cohort 2 Placebo | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 10 | 225.5 AU/mL |
| Cohort 2 Placebo | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 67 | 186.7 AU/mL |
| Cohort 2 Placebo | Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 2 | 237.2 AU/mL |
Secondary
Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set
At all visits, blood was collected for the determination of the immune response in serum. Anti-Tau IgG titers were measured by Meso Scale Discovery (MSD). For each visit, the geometric means (AU/mL) and 95% Confidence Interval (CI) is given.
Time frame: Endpoint is assessed from baseline (i.e. mean of the titers measured at the screening and visit 1 before the first study drug administration) to the last study visit (week 74), at weeks 0, 2, 8, 10, 24, 26, 36, 48, 50, 67 and 74.
Population: ITT population (i.e. all randomized subjects who received at least 1 dose of the study drug)
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 10 | 1508.6 AU/mL |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 2 | 2609.5 AU/mL |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 26 | 798.0 AU/mL |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 48 | 416.0 AU/mL |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 24 | 578.0 AU/mL |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 36 | 523.3 AU/mL |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 67 | 450.1 AU/mL |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 8 | 1065.0 AU/mL |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Baseline | 374.7 AU/mL |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 74 | 439.4 AU/mL |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 50 | 1023.0 AU/mL |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 50 | 1092.4 AU/mL |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 67 | 551.2 AU/mL |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 2 | 8753.9 AU/mL |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Baseline | 357.1 AU/mL |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 48 | 635.2 AU/mL |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 10 | 4217.5 AU/mL |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 8 | 3631.9 AU/mL |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 24 | 1124.8 AU/mL |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 26 | 1375.2 AU/mL |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 74 | 590.0 AU/mL |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 36 | 828.6 AU/mL |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 36 | 806.3 AU/mL |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 26 | 1859.0 AU/mL |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 2 | 6549.6 AU/mL |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Baseline | 355.4 AU/mL |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 67 | 570.6 AU/mL |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 8 | 2000.8 AU/mL |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 50 | 1132.9 AU/mL |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 10 | 2921.6 AU/mL |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 74 | 571.9 AU/mL |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 48 | 417.1 AU/mL |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 24 | 851.6 AU/mL |
| Cohort 1 Placebo | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 26 | 339.5 AU/mL |
| Cohort 1 Placebo | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Baseline | 251.7 AU/mL |
| Cohort 1 Placebo | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 2 | 230.4 AU/mL |
| Cohort 1 Placebo | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 8 | 243.1 AU/mL |
| Cohort 1 Placebo | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 10 | 242.5 AU/mL |
| Cohort 1 Placebo | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 24 | 343.3 AU/mL |
| Cohort 1 Placebo | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 36 | 240.6 AU/mL |
| Cohort 1 Placebo | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 48 | 243.1 AU/mL |
| Cohort 1 Placebo | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 50 | 231.8 AU/mL |
| Cohort 1 Placebo | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 67 | 269.6 AU/mL |
| Cohort 1 Placebo | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 74 | 253.3 AU/mL |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 24 | 16444.7 AU/mL |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Baseline | 223.0 AU/mL |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 36 | 59209.8 AU/mL |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 10 | 84688.8 AU/mL |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 48 | 25681.2 AU/mL |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 8 | 2564.1 AU/mL |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 74 | 51718.4 AU/mL |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 50 | 197833.5 AU/mL |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 2 | 744.5 AU/mL |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 67 | 69607.0 AU/mL |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 26 | 162241.1 AU/mL |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 48 | 13486.3 AU/mL |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 8 | 4349.6 AU/mL |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Baseline | 394.1 AU/mL |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 24 | 19762.7 AU/mL |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 26 | 74795.1 AU/mL |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 50 | 70122.6 AU/mL |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 2 | 2657.0 AU/mL |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 74 | 21920.5 AU/mL |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 67 | 32158.7 AU/mL |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 36 | 31504.2 AU/mL |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 10 | 46411.7 AU/mL |
| Cohort 2 Placebo | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 67 | 282.6 AU/mL |
| Cohort 2 Placebo | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 8 | 253.3 AU/mL |
| Cohort 2 Placebo | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 24 | 236.2 AU/mL |
| Cohort 2 Placebo | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 74 | 267.4 AU/mL |
| Cohort 2 Placebo | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Baseline | 261.0 AU/mL |
| Cohort 2 Placebo | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 36 | 310.1 AU/mL |
| Cohort 2 Placebo | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 10 | 262.8 AU/mL |
| Cohort 2 Placebo | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 50 | 286.5 AU/mL |
| Cohort 2 Placebo | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 2 | 233.7 AU/mL |
| Cohort 2 Placebo | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 48 | 282.8 AU/mL |
| Cohort 2 Placebo | Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set | Week 26 | 237.9 AU/mL |
Secondary
Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set
At all visits, blood was collected for the determination of the immune response in serum. Anti-Tau IgM titers were measured by enzyme-linked immunosorbent assay (ELISA). For each visit, the geometric means (AU/mL) and 95% Confidence Interval (CI) is given.
Time frame: Endpoint is assessed from baseline (i.e. mean of the titers measured at the screening and visit 1 before the first study drug administration) to the last study visit (week 74), at weeks 0, 2, 8, 10, 24, 26, 36, 48, 50, 67 and 74.
Population: ITT population (i.e. all randomized subjects who received at least 1 dose of the study drug).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 24 | 231.0 AU/mL |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Baseline | 153.0 AU/mL |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 8 | 228.3 AU/mL |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 74 | 144.1 AU/mL |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 67 | 147.8 AU/mL |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 50 | 171.9 AU/mL |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 48 | 111.6 AU/mL |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 36 | 95.2 AU/mL |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 10 | 220.8 AU/mL |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 26 | 256.0 AU/mL |
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 2 | 460.7 AU/mL |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 48 | 232.9 AU/mL |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 36 | 264.6 AU/mL |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 74 | 169.1 AU/mL |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 2 | 449.8 AU/mL |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 8 | 209.6 AU/mL |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 67 | 202.7 AU/mL |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 10 | 209.5 AU/mL |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Baseline | 93.1 AU/mL |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 24 | 134.2 AU/mL |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 50 | 349.2 AU/mL |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 26 | 198.8 AU/mL |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 2 | 737.8 AU/mL |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 74 | 329.9 AU/mL |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 36 | 476.7 AU/mL |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 10 | 409.5 AU/mL |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 26 | 286.2 AU/mL |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 48 | 468.3 AU/mL |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 24 | 181.2 AU/mL |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Baseline | 124.4 AU/mL |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 50 | 507.4 AU/mL |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 8 | 333.4 AU/mL |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 67 | 342.5 AU/mL |
| Cohort 1 Placebo | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 2 | 105.4 AU/mL |
| Cohort 1 Placebo | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 36 | 107.7 AU/mL |
| Cohort 1 Placebo | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 24 | 90.2 AU/mL |
| Cohort 1 Placebo | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Baseline | 108.1 AU/mL |
| Cohort 1 Placebo | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 8 | 98.2 AU/mL |
| Cohort 1 Placebo | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 10 | 101.3 AU/mL |
| Cohort 1 Placebo | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 74 | 128.2 AU/mL |
| Cohort 1 Placebo | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 67 | 109.7 AU/mL |
| Cohort 1 Placebo | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 50 | 108.3 AU/mL |
| Cohort 1 Placebo | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 48 | 120.9 AU/mL |
| Cohort 1 Placebo | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 26 | 87.2 AU/mL |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 36 | 101.1 AU/mL |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Baseline | 93.7 AU/mL |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 2 | 146.1 AU/mL |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 8 | 116.8 AU/mL |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 10 | 119.2 AU/mL |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 24 | 100.8 AU/mL |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 26 | 107.9 AU/mL |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 48 | 125.8 AU/mL |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 50 | 102.4 AU/mL |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 67 | 93.1 AU/mL |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 74 | 108.4 AU/mL |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Baseline | 94.6 AU/mL |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 26 | 105.9 AU/mL |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 24 | 102.3 AU/mL |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 50 | 110.1 AU/mL |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 10 | 123.2 AU/mL |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 8 | 101.3 AU/mL |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 74 | 130.6 AU/mL |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 67 | 130.9 AU/mL |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 2 | 139.6 AU/mL |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 36 | 100.1 AU/mL |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 48 | 133.4 AU/mL |
| Cohort 2 Placebo | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 26 | 103.3 AU/mL |
| Cohort 2 Placebo | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 48 | 162.6 AU/mL |
| Cohort 2 Placebo | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 2 | 129.9 AU/mL |
| Cohort 2 Placebo | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 24 | 104.1 AU/mL |
| Cohort 2 Placebo | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Baseline | 119.3 AU/mL |
| Cohort 2 Placebo | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 10 | 117.4 AU/mL |
| Cohort 2 Placebo | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 74 | 161.8 AU/mL |
| Cohort 2 Placebo | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 36 | 147.4 AU/mL |
| Cohort 2 Placebo | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 50 | 164.9 AU/mL |
| Cohort 2 Placebo | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 67 | 144.9 AU/mL |
| Cohort 2 Placebo | Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set | Week 8 | 116.5 AU/mL |
Other Pre-specified
Change From Baseline of Behavior Using NPI Scale
NPI means Neuropsychiatric Inventory. The score ranges from 0 to 144. A higher score indicates a worse outcome.
Time frame: from baseline up to week 74
Other Pre-specified
Change From Baseline of Cognitive Performance Using RBANS Scale
RBANS means Repeatable Battery for the Assessment of Neuropsychological Status. The total scale index score ranges from 40 to 160. A higher score indicates a better outcome.
Time frame: from baseline up to week 74
Other Pre-specified
Change From Baseline of Functional Performance Using CDR-SB Scale
CDR-SB means Clinical Dementia Rating - Sum of Boxes. The score ranges from 0 to 18. A higher score indicates a worse outcome.
Time frame: from baseline up to week 74