Alzheimer's Disease
Conditions
Keywords
Randomized, Safety Study, Open Label
Brief summary
This is a study to evaluate the safety and tolerability of multiple doses of AAB-003 (PF-05236812) in patients with mild to moderate Alzheimer's Disease. Patients who complete study B2601001 may participate in this trial and receive AAB-003 (PF-05236812). Each patient's participation will last approximately 52 weeks.
Interventions
0.5 mg/kg AAB-003, IV
Sponsors
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Successful completion of study B2601001 * MMSE 12 or greater
Exclusion criteria
* Study B2601001 Week 32 MRI with clinically important exclusionary findings. * Experienced SAE, vasogenic edema and/or intracranial hemorrhage in study B2601001
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Any New Magnetic Resonance Imaging (MRI) Findings | Baseline up to Week 52 | Brain MRIs were collected to assess for potential drug-related changes that might have constituted a safety concern. Findings suggestive of either vasogenic edema or intracranial hemorrhage were to be reported as AEs of special circumstance. |
| Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern | Baseline up to Week 52 | The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell \[RBC\] count, RBC morphology, platelet count, white blood cell \[WBC\] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen \[BUN\], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\], total bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, microscopy \[if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase\]); others (coagulation panel, circulating immune complex, and complement activation). |
| Number of Participants With Potentially Clinically Important Vital Sign Findings | Baseline up to Week 52 | Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine/sitting pulse rate \<40 or \>120 beats per minute (bpm); standing pulse rate \<40 or \>140 bpm; systolic blood pressure (SBP) of more than or equal to (\>=)30 millimeters of mercury (mm Hg) change from baseline in same posture or SBP \<90 mm Hg, diastolic blood pressure (DBP) \>=20 mmHg change from baseline in same posture or DBP \<50 mm Hg. |
| Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings | Baseline up to Week 52 | ECG parameters included PR interval, QRS interval, and QT interval. Criteria for ECG changes meeting potential clinical concern included: PR interval \>=300 milliseconds (msec) or \>=25% increase when baseline is \>200 msec and \>=50% increase when baseline is less than or equal to (\<=)200 msec; QRS interval \>=200 msec or \>=50% increase from baseline when baseline is less than or equal to 100 msec and \>=25% increase when baseline is \>100 msec; and QTcF \>=450 msec or \>=30 msec increase. |
| Number of Participants With Abnormal Physical Examination Findings | Baseline up to Week 52 | A full physical examination consisted of an examination of the abdomen, genitourinary and cardiovascular systems, lungs, lymph nodes, mouth, musculoskeletal and neurological systems, skin, extremities, head, ears, eyes, nose, throat and thyroid gland. Criteria for abnormal physical findings was based on the investigator's discretion and any new physical examination findings were documented as AEs. Only sites with at least 1 participant abnormality are reported. |
| Number of Participants With Abnormal Neurological Examination Findings | Baseline up to Week 52 | Neurological examinations were done to the extent needed to assess the subject for any potential changes in neurological status, as determined by the investigator. Examinations included level of consciousness, speech, cranial nerves, motor, sensory, coordination, gait, and tendon reflexes. Only tests with at least 1 participant abnormality are reported. |
| Number of Participants With Suicidal Ideation or Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline up to Week 52 | The C-SSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. C-SSRS assesses whether participant experienced the following: completed suicide; suicide attempt; preparatory acts towards imminent suicidal behavior; suicidal ideation; self-injurious behavior, no suicidal intent. The results presented are the number of participants with completed suicide or non-fatal suicide events or behaviors. Worsening of suicidal ideation was an increase in severity of suicidal ideation from baseline. |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to Week 52 | An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Scores at Week 52 | Baseline, Week 52 | ADAS-Cog is a structured scale that evaluates memory, orientation, attention, reasoning, language and constructional praxis. The ADAS-Cog comprises 11 items that are summed to a total score ranging from 0 to 70, with higher scores indicate greater cognitive impairment. |
| Change From Baseline in Disability Assessment in Dementia (DAD) at Week 52 | Baseline, Week 52 | The DAD is a functional assessment comprised of 40 items (17 items related to self-care and 23 items involving instrumental activities of daily living). The DAD assessment is scored from 0 to 100; higher scores indicate better function. |
| Change From Baseline in Neuropsychiatric Inventory (NPI) Behavioral Symptoms at Week 52 | Baseline, Week 52 | The NPI is an instrument used to assess changes of behavior that have appeared in a defined period of time in subjects with Alzheimer's Disease and other dementias. Twelve behavioral areas are assessed: delusions, apathy, hallucinations, disinhibition, agitation, irritability, depression, aberrant motor behavior, anxiety, nighttime behaviors, euphoria, appetite, and eating changes. The NPI score is based on frequency and severity of specific behaviors within these categories. Severity (1=Mild to 3=Severe), frequency (1=occasionally to 4=very frequently) scales recorded for each domain; frequency\*severity=each domain score (range 0-12). Total score=sum of each domain score (range 0-144); higher score=greater behavioral disturbances; negative change score from baseline=improvement. |
| Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) Scores at Week 52 | Baseline, Week 52 | The CDR scale is a dementia staging instrument that tracks the progression of cognitive impairment in the following 6 categories: memory, orientation, judgment and problem solving, involvement in community affairs, home and hobbies, and personal care. The CDR-SB scale is obtained by summing the ratings in each of the 6 categories, ranging from 0 to 18. Higher scores indicate greater disease severity. |
| Change From Baseline in Mini-Mental State Exam (MMSE) Scores at Week 52 | Baseline, Week 52 | The MMSE is a brief 30-point questionnaire test that is used to assess cognition. Scores range from 0 to 30, with higher scores indicating better cognitive state. |
| Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer | Baseline, Week 52 | Number of participants with positive sample(s) in the ADA assay and in the neutralizing anti-drug antibodies (NAb) assay. An endpoint titer \>=6.64 corresponded to positive ADA category value. The number of participants who tested positive on 1 or more occasions is reported. |
Countries
South Korea, United States
Participant flow
Recruitment details
This study enrolled participants who completed the first-in-human (FIH) study, B2601001.
Participants by arm
| Arm | Count |
|---|---|
| AAB-003 0.5 mg/kg Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions. | 6 |
| AAB-003 1 mg/kg Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions. | 3 |
| AAB-003 2 mg/kg Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions. | 12 |
| AAB-003 4 mg/kg Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions. | 10 |
| AAB-003 8 mg/kg Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions. | 12 |
| Placebo/AAB-003 Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions. | 9 |
| Total | 52 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 1 | 1 | 0 |
| Overall Study | Does Not Meet Entrance Criteria | 0 | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Other | 1 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 2 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | AAB-003 0.5 mg/kg | AAB-003 1 mg/kg | AAB-003 2 mg/kg | AAB-003 4 mg/kg | AAB-003 8 mg/kg | Placebo/AAB-003 | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 65.2 years STANDARD_DEVIATION 6.5 | 63.0 years STANDARD_DEVIATION 7.8 | 68.8 years STANDARD_DEVIATION 10.6 | 71.3 years STANDARD_DEVIATION 8.8 | 60.7 years STANDARD_DEVIATION 5.8 | 71.7 years STANDARD_DEVIATION 7.9 | 67.1 years STANDARD_DEVIATION 9 |
| Sex: Female, Male Female | 4 Participants | 2 Participants | 10 Participants | 5 Participants | 8 Participants | 4 Participants | 33 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 2 Participants | 5 Participants | 4 Participants | 5 Participants | 19 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 |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 5 / 6 | 3 / 3 | 9 / 12 | 4 / 10 | 10 / 12 | 8 / 9 |
| serious Total, serious adverse events | 0 / 6 | 1 / 3 | 2 / 12 | 3 / 10 | 1 / 12 | 1 / 9 |
Outcome results
Primary
Number of Participants With Abnormal Neurological Examination Findings
Neurological examinations were done to the extent needed to assess the subject for any potential changes in neurological status, as determined by the investigator. Examinations included level of consciousness, speech, cranial nerves, motor, sensory, coordination, gait, and tendon reflexes. Only tests with at least 1 participant abnormality are reported.
Time frame: Baseline up to Week 52
Population: The safety analysis set included participants who received at least 1 infusion of study medication (including partial infusions).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AAB-003 0.5 mg/kg | Number of Participants With Abnormal Neurological Examination Findings | Deep Tendon Reflexes | 0 participants |
| AAB-003 0.5 mg/kg | Number of Participants With Abnormal Neurological Examination Findings | Motor Function | 0 participants |
| AAB-003 0.5 mg/kg | Number of Participants With Abnormal Neurological Examination Findings | Coordination | 0 participants |
| AAB-003 0.5 mg/kg | Number of Participants With Abnormal Neurological Examination Findings | Gait and Station | 0 participants |
| AAB-003 0.5 mg/kg | Number of Participants With Abnormal Neurological Examination Findings | Cranial Nerve Function | 1 participants |
| AAB-003 1 mg/kg | Number of Participants With Abnormal Neurological Examination Findings | Gait and Station | 1 participants |
| AAB-003 1 mg/kg | Number of Participants With Abnormal Neurological Examination Findings | Coordination | 0 participants |
| AAB-003 1 mg/kg | Number of Participants With Abnormal Neurological Examination Findings | Motor Function | 1 participants |
| AAB-003 1 mg/kg | Number of Participants With Abnormal Neurological Examination Findings | Cranial Nerve Function | 0 participants |
| AAB-003 1 mg/kg | Number of Participants With Abnormal Neurological Examination Findings | Deep Tendon Reflexes | 0 participants |
| AAB-003 2 mg/kg | Number of Participants With Abnormal Neurological Examination Findings | Cranial Nerve Function | 0 participants |
| AAB-003 2 mg/kg | Number of Participants With Abnormal Neurological Examination Findings | Coordination | 0 participants |
| AAB-003 2 mg/kg | Number of Participants With Abnormal Neurological Examination Findings | Gait and Station | 0 participants |
| AAB-003 2 mg/kg | Number of Participants With Abnormal Neurological Examination Findings | Deep Tendon Reflexes | 1 participants |
| AAB-003 2 mg/kg | Number of Participants With Abnormal Neurological Examination Findings | Motor Function | 0 participants |
| AAB-003 4 mg/kg | Number of Participants With Abnormal Neurological Examination Findings | Cranial Nerve Function | 2 participants |
| AAB-003 4 mg/kg | Number of Participants With Abnormal Neurological Examination Findings | Motor Function | 0 participants |
| AAB-003 4 mg/kg | Number of Participants With Abnormal Neurological Examination Findings | Deep Tendon Reflexes | 0 participants |
| AAB-003 4 mg/kg | Number of Participants With Abnormal Neurological Examination Findings | Gait and Station | 0 participants |
| AAB-003 4 mg/kg | Number of Participants With Abnormal Neurological Examination Findings | Coordination | 1 participants |
| AAB-003 8 mg/kg | Number of Participants With Abnormal Neurological Examination Findings | Coordination | 0 participants |
| AAB-003 8 mg/kg | Number of Participants With Abnormal Neurological Examination Findings | Deep Tendon Reflexes | 0 participants |
| AAB-003 8 mg/kg | Number of Participants With Abnormal Neurological Examination Findings | Motor Function | 0 participants |
| AAB-003 8 mg/kg | Number of Participants With Abnormal Neurological Examination Findings | Cranial Nerve Function | 0 participants |
| AAB-003 8 mg/kg | Number of Participants With Abnormal Neurological Examination Findings | Gait and Station | 0 participants |
| Placebo/AAB-003 | Number of Participants With Abnormal Neurological Examination Findings | Coordination | 1 participants |
| Placebo/AAB-003 | Number of Participants With Abnormal Neurological Examination Findings | Cranial Nerve Function | 0 participants |
| Placebo/AAB-003 | Number of Participants With Abnormal Neurological Examination Findings | Gait and Station | 1 participants |
| Placebo/AAB-003 | Number of Participants With Abnormal Neurological Examination Findings | Deep Tendon Reflexes | 0 participants |
| Placebo/AAB-003 | Number of Participants With Abnormal Neurological Examination Findings | Motor Function | 1 participants |
Primary
Number of Participants With Abnormal Physical Examination Findings
A full physical examination consisted of an examination of the abdomen, genitourinary and cardiovascular systems, lungs, lymph nodes, mouth, musculoskeletal and neurological systems, skin, extremities, head, ears, eyes, nose, throat and thyroid gland. Criteria for abnormal physical findings was based on the investigator's discretion and any new physical examination findings were documented as AEs. Only sites with at least 1 participant abnormality are reported.
Time frame: Baseline up to Week 52
Population: The safety analysis set included participants who received at least 1 infusion of study medication (including partial infusions).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AAB-003 0.5 mg/kg | Number of Participants With Abnormal Physical Examination Findings | Ears | 0 participants |
| AAB-003 0.5 mg/kg | Number of Participants With Abnormal Physical Examination Findings | Abdomen | 0 participants |
| AAB-003 0.5 mg/kg | Number of Participants With Abnormal Physical Examination Findings | Skin | 0 participants |
| AAB-003 0.5 mg/kg | Number of Participants With Abnormal Physical Examination Findings | Nose | 1 participants |
| AAB-003 0.5 mg/kg | Number of Participants With Abnormal Physical Examination Findings | Eyes | 1 participants |
| AAB-003 0.5 mg/kg | Number of Participants With Abnormal Physical Examination Findings | Musculoskeletal | 0 participants |
| AAB-003 0.5 mg/kg | Number of Participants With Abnormal Physical Examination Findings | Lymph Nodes | 0 participants |
| AAB-003 0.5 mg/kg | Number of Participants With Abnormal Physical Examination Findings | General | 0 participants |
| AAB-003 0.5 mg/kg | Number of Participants With Abnormal Physical Examination Findings | Thyroid | 0 participants |
| AAB-003 0.5 mg/kg | Number of Participants With Abnormal Physical Examination Findings | Extremities | 0 participants |
| AAB-003 1 mg/kg | Number of Participants With Abnormal Physical Examination Findings | Skin | 0 participants |
| AAB-003 1 mg/kg | Number of Participants With Abnormal Physical Examination Findings | General | 0 participants |
| AAB-003 1 mg/kg | Number of Participants With Abnormal Physical Examination Findings | Thyroid | 0 participants |
| AAB-003 1 mg/kg | Number of Participants With Abnormal Physical Examination Findings | Abdomen | 0 participants |
| AAB-003 1 mg/kg | Number of Participants With Abnormal Physical Examination Findings | Extremities | 0 participants |
| AAB-003 1 mg/kg | Number of Participants With Abnormal Physical Examination Findings | Eyes | 0 participants |
| AAB-003 1 mg/kg | Number of Participants With Abnormal Physical Examination Findings | Lymph Nodes | 1 participants |
| AAB-003 1 mg/kg | Number of Participants With Abnormal Physical Examination Findings | Musculoskeletal | 1 participants |
| AAB-003 1 mg/kg | Number of Participants With Abnormal Physical Examination Findings | Nose | 0 participants |
| AAB-003 1 mg/kg | Number of Participants With Abnormal Physical Examination Findings | Ears | 0 participants |
| AAB-003 2 mg/kg | Number of Participants With Abnormal Physical Examination Findings | Eyes | 0 participants |
| AAB-003 2 mg/kg | Number of Participants With Abnormal Physical Examination Findings | Musculoskeletal | 0 participants |
| AAB-003 2 mg/kg | Number of Participants With Abnormal Physical Examination Findings | Nose | 0 participants |
| AAB-003 2 mg/kg | Number of Participants With Abnormal Physical Examination Findings | Extremities | 0 participants |
| AAB-003 2 mg/kg | Number of Participants With Abnormal Physical Examination Findings | Ears | 0 participants |
| AAB-003 2 mg/kg | Number of Participants With Abnormal Physical Examination Findings | Abdomen | 1 participants |
| AAB-003 2 mg/kg | Number of Participants With Abnormal Physical Examination Findings | Skin | 0 participants |
| AAB-003 2 mg/kg | Number of Participants With Abnormal Physical Examination Findings | Thyroid | 0 participants |
| AAB-003 2 mg/kg | Number of Participants With Abnormal Physical Examination Findings | Lymph Nodes | 0 participants |
| AAB-003 2 mg/kg | Number of Participants With Abnormal Physical Examination Findings | General | 1 participants |
| AAB-003 4 mg/kg | Number of Participants With Abnormal Physical Examination Findings | Lymph Nodes | 0 participants |
| AAB-003 4 mg/kg | Number of Participants With Abnormal Physical Examination Findings | Thyroid | 1 participants |
| AAB-003 4 mg/kg | Number of Participants With Abnormal Physical Examination Findings | General | 0 participants |
| AAB-003 4 mg/kg | Number of Participants With Abnormal Physical Examination Findings | Abdomen | 0 participants |
| AAB-003 4 mg/kg | Number of Participants With Abnormal Physical Examination Findings | Nose | 0 participants |
| AAB-003 4 mg/kg | Number of Participants With Abnormal Physical Examination Findings | Musculoskeletal | 0 participants |
| AAB-003 4 mg/kg | Number of Participants With Abnormal Physical Examination Findings | Skin | 2 participants |
| AAB-003 4 mg/kg | Number of Participants With Abnormal Physical Examination Findings | Extremities | 0 participants |
| AAB-003 4 mg/kg | Number of Participants With Abnormal Physical Examination Findings | Eyes | 0 participants |
| AAB-003 4 mg/kg | Number of Participants With Abnormal Physical Examination Findings | Ears | 2 participants |
| AAB-003 8 mg/kg | Number of Participants With Abnormal Physical Examination Findings | Abdomen | 0 participants |
| AAB-003 8 mg/kg | Number of Participants With Abnormal Physical Examination Findings | Ears | 1 participants |
| AAB-003 8 mg/kg | Number of Participants With Abnormal Physical Examination Findings | Eyes | 0 participants |
| AAB-003 8 mg/kg | Number of Participants With Abnormal Physical Examination Findings | General | 0 participants |
| AAB-003 8 mg/kg | Number of Participants With Abnormal Physical Examination Findings | Lymph Nodes | 0 participants |
| AAB-003 8 mg/kg | Number of Participants With Abnormal Physical Examination Findings | Musculoskeletal | 0 participants |
| AAB-003 8 mg/kg | Number of Participants With Abnormal Physical Examination Findings | Thyroid | 0 participants |
| AAB-003 8 mg/kg | Number of Participants With Abnormal Physical Examination Findings | Nose | 0 participants |
| AAB-003 8 mg/kg | Number of Participants With Abnormal Physical Examination Findings | Extremities | 0 participants |
| AAB-003 8 mg/kg | Number of Participants With Abnormal Physical Examination Findings | Skin | 0 participants |
| Placebo/AAB-003 | Number of Participants With Abnormal Physical Examination Findings | Nose | 0 participants |
| Placebo/AAB-003 | Number of Participants With Abnormal Physical Examination Findings | Ears | 0 participants |
| Placebo/AAB-003 | Number of Participants With Abnormal Physical Examination Findings | Lymph Nodes | 0 participants |
| Placebo/AAB-003 | Number of Participants With Abnormal Physical Examination Findings | Thyroid | 0 participants |
| Placebo/AAB-003 | Number of Participants With Abnormal Physical Examination Findings | General | 0 participants |
| Placebo/AAB-003 | Number of Participants With Abnormal Physical Examination Findings | Abdomen | 0 participants |
| Placebo/AAB-003 | Number of Participants With Abnormal Physical Examination Findings | Eyes | 0 participants |
| Placebo/AAB-003 | Number of Participants With Abnormal Physical Examination Findings | Extremities | 1 participants |
| Placebo/AAB-003 | Number of Participants With Abnormal Physical Examination Findings | Musculoskeletal | 1 participants |
| Placebo/AAB-003 | Number of Participants With Abnormal Physical Examination Findings | Skin | 1 participants |
Primary
Number of Participants With Any New Magnetic Resonance Imaging (MRI) Findings
Brain MRIs were collected to assess for potential drug-related changes that might have constituted a safety concern. Findings suggestive of either vasogenic edema or intracranial hemorrhage were to be reported as AEs of special circumstance.
Time frame: Baseline up to Week 52
Population: The safety analysis set included participants who received at least 1 infusion of study medication (including partial infusions).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AAB-003 0.5 mg/kg | Number of Participants With Any New Magnetic Resonance Imaging (MRI) Findings | 1 participants |
| AAB-003 1 mg/kg | Number of Participants With Any New Magnetic Resonance Imaging (MRI) Findings | 1 participants |
| AAB-003 2 mg/kg | Number of Participants With Any New Magnetic Resonance Imaging (MRI) Findings | 0 participants |
| AAB-003 4 mg/kg | Number of Participants With Any New Magnetic Resonance Imaging (MRI) Findings | 0 participants |
| AAB-003 8 mg/kg | Number of Participants With Any New Magnetic Resonance Imaging (MRI) Findings | 0 participants |
| Placebo/AAB-003 | Number of Participants With Any New Magnetic Resonance Imaging (MRI) Findings | 1 participants |
Primary
Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern
The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell \[RBC\] count, RBC morphology, platelet count, white blood cell \[WBC\] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen \[BUN\], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\], total bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, microscopy \[if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase\]); others (coagulation panel, circulating immune complex, and complement activation).
Time frame: Baseline up to Week 52
Population: The safety analysis set included participants who received at least 1 infusion of study medication (including partial infusions).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AAB-003 0.5 mg/kg | Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern | 3 participants |
| AAB-003 1 mg/kg | Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern | 2 participants |
| AAB-003 2 mg/kg | Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern | 8 participants |
| AAB-003 4 mg/kg | Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern | 7 participants |
| AAB-003 8 mg/kg | Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern | 10 participants |
| Placebo/AAB-003 | Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern | 6 participants |
Primary
Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings
ECG parameters included PR interval, QRS interval, and QT interval. Criteria for ECG changes meeting potential clinical concern included: PR interval \>=300 milliseconds (msec) or \>=25% increase when baseline is \>200 msec and \>=50% increase when baseline is less than or equal to (\<=)200 msec; QRS interval \>=200 msec or \>=50% increase from baseline when baseline is less than or equal to 100 msec and \>=25% increase when baseline is \>100 msec; and QTcF \>=450 msec or \>=30 msec increase.
Time frame: Baseline up to Week 52
Population: The safety analysis set included participants who received at least 1 infusion of study medication (including partial infusions).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AAB-003 0.5 mg/kg | Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings | QTcF Interval 450 to <480 msec | 0 participants |
| AAB-003 0.5 mg/kg | Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings | QTcF Interval 480 to <500 msec | 0 participants |
| AAB-003 0.5 mg/kg | Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings | QTcF Interval >=30/<60 msec Change from Baseline | 2 participants |
| AAB-003 0.5 mg/kg | Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings | QRS Complex >=25/50% Increase from Baseline | 0 participants |
| AAB-003 0.5 mg/kg | Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings | PR Interval >=300 msec | 0 participants |
| AAB-003 0.5 mg/kg | Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings | QTcF Interval >=60 msec Change from Baseline | 0 participants |
| AAB-003 0.5 mg/kg | Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings | QRS Complex >=200 msec | 0 participants |
| AAB-003 0.5 mg/kg | Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings | PR Interval >=25/50% Increase from Baseline | 0 participants |
| AAB-003 0.5 mg/kg | Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings | QTcF Interval >=500 msec | 0 participants |
| AAB-003 1 mg/kg | Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings | PR Interval >=300 msec | 0 participants |
| AAB-003 1 mg/kg | Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings | QTcF Interval 450 to <480 msec | 2 participants |
| AAB-003 1 mg/kg | Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings | QTcF Interval >=60 msec Change from Baseline | 0 participants |
| AAB-003 1 mg/kg | Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings | QTcF Interval 480 to <500 msec | 0 participants |
| AAB-003 1 mg/kg | Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings | QTcF Interval >=500 msec | 0 participants |
| AAB-003 1 mg/kg | Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings | QTcF Interval >=30/<60 msec Change from Baseline | 1 participants |
| AAB-003 1 mg/kg | Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings | PR Interval >=25/50% Increase from Baseline | 0 participants |
| AAB-003 1 mg/kg | Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings | QRS Complex >=25/50% Increase from Baseline | 0 participants |
| AAB-003 1 mg/kg | Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings | QRS Complex >=200 msec | 0 participants |
| AAB-003 2 mg/kg | Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings | PR Interval >=300 msec | 0 participants |
| AAB-003 2 mg/kg | Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings | QTcF Interval >=60 msec Change from Baseline | 1 participants |
| AAB-003 2 mg/kg | Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings | QTcF Interval >=30/<60 msec Change from Baseline | 4 participants |
| AAB-003 2 mg/kg | Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings | QTcF Interval 480 to <500 msec | 1 participants |
| AAB-003 2 mg/kg | Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings | QTcF Interval 450 to <480 msec | 4 participants |
| AAB-003 2 mg/kg | Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings | QTcF Interval >=500 msec | 1 participants |
| AAB-003 2 mg/kg | Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings | QRS Complex >=200 msec | 0 participants |
| AAB-003 2 mg/kg | Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings | PR Interval >=25/50% Increase from Baseline | 0 participants |
| AAB-003 2 mg/kg | Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings | QRS Complex >=25/50% Increase from Baseline | 0 participants |
| AAB-003 4 mg/kg | Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings | QTcF Interval 480 to <500 msec | 1 participants |
| AAB-003 4 mg/kg | Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings | QTcF Interval >=500 msec | 0 participants |
| AAB-003 4 mg/kg | Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings | QRS Complex >=25/50% Increase from Baseline | 0 participants |
| AAB-003 4 mg/kg | Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings | QRS Complex >=200 msec | 0 participants |
| AAB-003 4 mg/kg | Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings | PR Interval >=300 msec | 0 participants |
| AAB-003 4 mg/kg | Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings | QTcF Interval >=60 msec Change from Baseline | 1 participants |
| AAB-003 4 mg/kg | Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings | QTcF Interval >=30/<60 msec Change from Baseline | 4 participants |
| AAB-003 4 mg/kg | Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings | PR Interval >=25/50% Increase from Baseline | 0 participants |
| AAB-003 4 mg/kg | Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings | QTcF Interval 450 to <480 msec | 3 participants |
| AAB-003 8 mg/kg | Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings | QTcF Interval 480 to <500 msec | 1 participants |
| AAB-003 8 mg/kg | Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings | QRS Complex >=25/50% Increase from Baseline | 0 participants |
| AAB-003 8 mg/kg | Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings | QTcF Interval >=500 msec | 0 participants |
| AAB-003 8 mg/kg | Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings | QRS Complex >=200 msec | 0 participants |
| AAB-003 8 mg/kg | Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings | QTcF Interval >=30/<60 msec Change from Baseline | 1 participants |
| AAB-003 8 mg/kg | Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings | PR Interval >=25/50% Increase from Baseline | 0 participants |
| AAB-003 8 mg/kg | Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings | QTcF Interval 450 to <480 msec | 2 participants |
| AAB-003 8 mg/kg | Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings | PR Interval >=300 msec | 0 participants |
| AAB-003 8 mg/kg | Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings | QTcF Interval >=60 msec Change from Baseline | 0 participants |
| Placebo/AAB-003 | Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings | QTcF Interval >=60 msec Change from Baseline | 0 participants |
| Placebo/AAB-003 | Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings | QRS Complex >=25/50% Increase from Baseline | 0 participants |
| Placebo/AAB-003 | Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings | PR Interval >=300 msec | 0 participants |
| Placebo/AAB-003 | Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings | QRS Complex >=200 msec | 0 participants |
| Placebo/AAB-003 | Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings | QTcF Interval 450 to <480 msec | 2 participants |
| Placebo/AAB-003 | Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings | QTcF Interval 480 to <500 msec | 0 participants |
| Placebo/AAB-003 | Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings | QTcF Interval >=500 msec | 0 participants |
| Placebo/AAB-003 | Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings | PR Interval >=25/50% Increase from Baseline | 0 participants |
| Placebo/AAB-003 | Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings | QTcF Interval >=30/<60 msec Change from Baseline | 2 participants |
Primary
Number of Participants With Potentially Clinically Important Vital Sign Findings
Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine/sitting pulse rate \<40 or \>120 beats per minute (bpm); standing pulse rate \<40 or \>140 bpm; systolic blood pressure (SBP) of more than or equal to (\>=)30 millimeters of mercury (mm Hg) change from baseline in same posture or SBP \<90 mm Hg, diastolic blood pressure (DBP) \>=20 mmHg change from baseline in same posture or DBP \<50 mm Hg.
Time frame: Baseline up to Week 52
Population: The safety analysis set included participants who received at least 1 infusion of study medication (including partial infusions).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AAB-003 0.5 mg/kg | Number of Participants With Potentially Clinically Important Vital Sign Findings | Supine SBP <90 mm Hg | 1 participants |
| AAB-003 0.5 mg/kg | Number of Participants With Potentially Clinically Important Vital Sign Findings | Supine Pulse Rate <40 or >120 bpm | 0 participants |
| AAB-003 0.5 mg/kg | Number of Participants With Potentially Clinically Important Vital Sign Findings | Supine DBP <50 mm Hg | 0 participants |
| AAB-003 0.5 mg/kg | Number of Participants With Potentially Clinically Important Vital Sign Findings | Supine SBP >=30 mm Hg Increase from Baseline | 3 participants |
| AAB-003 0.5 mg/kg | Number of Participants With Potentially Clinically Important Vital Sign Findings | Supine SBP >=30 mm Hg Decrease from Baseline | 0 participants |
| AAB-003 0.5 mg/kg | Number of Participants With Potentially Clinically Important Vital Sign Findings | Supine DBP >=20 mm Hg Increase from Baseline | 2 participants |
| AAB-003 0.5 mg/kg | Number of Participants With Potentially Clinically Important Vital Sign Findings | Supine DBP >=20 mm Hg Decrease from Baseline | 0 participants |
| AAB-003 1 mg/kg | Number of Participants With Potentially Clinically Important Vital Sign Findings | Supine SBP >=30 mm Hg Decrease from Baseline | 1 participants |
| AAB-003 1 mg/kg | Number of Participants With Potentially Clinically Important Vital Sign Findings | Supine SBP >=30 mm Hg Increase from Baseline | 1 participants |
| AAB-003 1 mg/kg | Number of Participants With Potentially Clinically Important Vital Sign Findings | Supine DBP >=20 mm Hg Increase from Baseline | 1 participants |
| AAB-003 1 mg/kg | Number of Participants With Potentially Clinically Important Vital Sign Findings | Supine SBP <90 mm Hg | 0 participants |
| AAB-003 1 mg/kg | Number of Participants With Potentially Clinically Important Vital Sign Findings | Supine DBP <50 mm Hg | 0 participants |
| AAB-003 1 mg/kg | Number of Participants With Potentially Clinically Important Vital Sign Findings | Supine DBP >=20 mm Hg Decrease from Baseline | 1 participants |
| AAB-003 1 mg/kg | Number of Participants With Potentially Clinically Important Vital Sign Findings | Supine Pulse Rate <40 or >120 bpm | 0 participants |
| AAB-003 2 mg/kg | Number of Participants With Potentially Clinically Important Vital Sign Findings | Supine DBP <50 mm Hg | 1 participants |
| AAB-003 2 mg/kg | Number of Participants With Potentially Clinically Important Vital Sign Findings | Supine DBP >=20 mm Hg Decrease from Baseline | 5 participants |
| AAB-003 2 mg/kg | Number of Participants With Potentially Clinically Important Vital Sign Findings | Supine SBP >=30 mm Hg Decrease from Baseline | 4 participants |
| AAB-003 2 mg/kg | Number of Participants With Potentially Clinically Important Vital Sign Findings | Supine SBP >=30 mm Hg Increase from Baseline | 1 participants |
| AAB-003 2 mg/kg | Number of Participants With Potentially Clinically Important Vital Sign Findings | Supine DBP >=20 mm Hg Increase from Baseline | 4 participants |
| AAB-003 2 mg/kg | Number of Participants With Potentially Clinically Important Vital Sign Findings | Supine SBP <90 mm Hg | 0 participants |
| AAB-003 2 mg/kg | Number of Participants With Potentially Clinically Important Vital Sign Findings | Supine Pulse Rate <40 or >120 bpm | 0 participants |
| AAB-003 4 mg/kg | Number of Participants With Potentially Clinically Important Vital Sign Findings | Supine SBP >=30 mm Hg Decrease from Baseline | 1 participants |
| AAB-003 4 mg/kg | Number of Participants With Potentially Clinically Important Vital Sign Findings | Supine DBP >=20 mm Hg Decrease from Baseline | 3 participants |
| AAB-003 4 mg/kg | Number of Participants With Potentially Clinically Important Vital Sign Findings | Supine SBP <90 mm Hg | 0 participants |
| AAB-003 4 mg/kg | Number of Participants With Potentially Clinically Important Vital Sign Findings | Supine DBP <50 mm Hg | 3 participants |
| AAB-003 4 mg/kg | Number of Participants With Potentially Clinically Important Vital Sign Findings | Supine Pulse Rate <40 or >120 bpm | 0 participants |
| AAB-003 4 mg/kg | Number of Participants With Potentially Clinically Important Vital Sign Findings | Supine SBP >=30 mm Hg Increase from Baseline | 2 participants |
| AAB-003 4 mg/kg | Number of Participants With Potentially Clinically Important Vital Sign Findings | Supine DBP >=20 mm Hg Increase from Baseline | 5 participants |
| AAB-003 8 mg/kg | Number of Participants With Potentially Clinically Important Vital Sign Findings | Supine SBP >=30 mm Hg Increase from Baseline | 4 participants |
| AAB-003 8 mg/kg | Number of Participants With Potentially Clinically Important Vital Sign Findings | Supine DBP >=20 mm Hg Increase from Baseline | 1 participants |
| AAB-003 8 mg/kg | Number of Participants With Potentially Clinically Important Vital Sign Findings | Supine SBP >=30 mm Hg Decrease from Baseline | 2 participants |
| AAB-003 8 mg/kg | Number of Participants With Potentially Clinically Important Vital Sign Findings | Supine Pulse Rate <40 or >120 bpm | 1 participants |
| AAB-003 8 mg/kg | Number of Participants With Potentially Clinically Important Vital Sign Findings | Supine SBP <90 mm Hg | 0 participants |
| AAB-003 8 mg/kg | Number of Participants With Potentially Clinically Important Vital Sign Findings | Supine DBP >=20 mm Hg Decrease from Baseline | 3 participants |
| AAB-003 8 mg/kg | Number of Participants With Potentially Clinically Important Vital Sign Findings | Supine DBP <50 mm Hg | 0 participants |
| Placebo/AAB-003 | Number of Participants With Potentially Clinically Important Vital Sign Findings | Supine DBP >=20 mm Hg Decrease from Baseline | 5 participants |
| Placebo/AAB-003 | Number of Participants With Potentially Clinically Important Vital Sign Findings | Supine DBP <50 mm Hg | 0 participants |
| Placebo/AAB-003 | Number of Participants With Potentially Clinically Important Vital Sign Findings | Supine DBP >=20 mm Hg Increase from Baseline | 2 participants |
| Placebo/AAB-003 | Number of Participants With Potentially Clinically Important Vital Sign Findings | Supine SBP <90 mm Hg | 1 participants |
| Placebo/AAB-003 | Number of Participants With Potentially Clinically Important Vital Sign Findings | Supine Pulse Rate <40 or >120 bpm | 0 participants |
| Placebo/AAB-003 | Number of Participants With Potentially Clinically Important Vital Sign Findings | Supine SBP >=30 mm Hg Increase from Baseline | 1 participants |
| Placebo/AAB-003 | Number of Participants With Potentially Clinically Important Vital Sign Findings | Supine SBP >=30 mm Hg Decrease from Baseline | 4 participants |
Primary
Number of Participants With Suicidal Ideation or Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
The C-SSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. C-SSRS assesses whether participant experienced the following: completed suicide; suicide attempt; preparatory acts towards imminent suicidal behavior; suicidal ideation; self-injurious behavior, no suicidal intent. The results presented are the number of participants with completed suicide or non-fatal suicide events or behaviors. Worsening of suicidal ideation was an increase in severity of suicidal ideation from baseline.
Time frame: Baseline up to Week 52
Population: The safety analysis set included participants who received at least 1 infusion of study medication (including partial infusions).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AAB-003 0.5 mg/kg | Number of Participants With Suicidal Ideation or Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal Ideation | 0 participants |
| AAB-003 0.5 mg/kg | Number of Participants With Suicidal Ideation or Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicide Attempt | 0 participants |
| AAB-003 0.5 mg/kg | Number of Participants With Suicidal Ideation or Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) | Self-Injurious Behavior, No Suicidal Attempt | 0 participants |
| AAB-003 0.5 mg/kg | Number of Participants With Suicidal Ideation or Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) | Completed Suicide | 0 participants |
| AAB-003 0.5 mg/kg | Number of Participants With Suicidal Ideation or Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) | Imminent Suicidal Behavior | 0 participants |
| AAB-003 1 mg/kg | Number of Participants With Suicidal Ideation or Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicide Attempt | 0 participants |
| AAB-003 1 mg/kg | Number of Participants With Suicidal Ideation or Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) | Imminent Suicidal Behavior | 0 participants |
| AAB-003 1 mg/kg | Number of Participants With Suicidal Ideation or Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) | Self-Injurious Behavior, No Suicidal Attempt | 0 participants |
| AAB-003 1 mg/kg | Number of Participants With Suicidal Ideation or Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal Ideation | 0 participants |
| AAB-003 1 mg/kg | Number of Participants With Suicidal Ideation or Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) | Completed Suicide | 0 participants |
| AAB-003 2 mg/kg | Number of Participants With Suicidal Ideation or Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicide Attempt | 0 participants |
| AAB-003 2 mg/kg | Number of Participants With Suicidal Ideation or Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) | Completed Suicide | 0 participants |
| AAB-003 2 mg/kg | Number of Participants With Suicidal Ideation or Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) | Self-Injurious Behavior, No Suicidal Attempt | 0 participants |
| AAB-003 2 mg/kg | Number of Participants With Suicidal Ideation or Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) | Imminent Suicidal Behavior | 0 participants |
| AAB-003 2 mg/kg | Number of Participants With Suicidal Ideation or Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal Ideation | 1 participants |
| AAB-003 4 mg/kg | Number of Participants With Suicidal Ideation or Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) | Imminent Suicidal Behavior | 0 participants |
| AAB-003 4 mg/kg | Number of Participants With Suicidal Ideation or Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicide Attempt | 0 participants |
| AAB-003 4 mg/kg | Number of Participants With Suicidal Ideation or Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) | Self-Injurious Behavior, No Suicidal Attempt | 0 participants |
| AAB-003 4 mg/kg | Number of Participants With Suicidal Ideation or Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) | Completed Suicide | 0 participants |
| AAB-003 4 mg/kg | Number of Participants With Suicidal Ideation or Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal Ideation | 0 participants |
| AAB-003 8 mg/kg | Number of Participants With Suicidal Ideation or Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) | Completed Suicide | 0 participants |
| AAB-003 8 mg/kg | Number of Participants With Suicidal Ideation or Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) | Imminent Suicidal Behavior | 0 participants |
| AAB-003 8 mg/kg | Number of Participants With Suicidal Ideation or Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicide Attempt | 0 participants |
| AAB-003 8 mg/kg | Number of Participants With Suicidal Ideation or Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal Ideation | 1 participants |
| AAB-003 8 mg/kg | Number of Participants With Suicidal Ideation or Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) | Self-Injurious Behavior, No Suicidal Attempt | 0 participants |
| Placebo/AAB-003 | Number of Participants With Suicidal Ideation or Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal Ideation | 0 participants |
| Placebo/AAB-003 | Number of Participants With Suicidal Ideation or Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicide Attempt | 0 participants |
| Placebo/AAB-003 | Number of Participants With Suicidal Ideation or Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) | Completed Suicide | 0 participants |
| Placebo/AAB-003 | Number of Participants With Suicidal Ideation or Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) | Imminent Suicidal Behavior | 0 participants |
| Placebo/AAB-003 | Number of Participants With Suicidal Ideation or Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) | Self-Injurious Behavior, No Suicidal Attempt | 0 participants |
Primary
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.
Time frame: Baseline up to Week 52
Population: The safety analysis set included participants who received at least 1 infusion of study medication (including partial infusions).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AAB-003 0.5 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Number of Participants with AEs | 5 participants |
| AAB-003 0.5 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Number of Participants with SAEs | 0 participants |
| AAB-003 1 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Number of Participants with SAEs | 1 participants |
| AAB-003 1 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Number of Participants with AEs | 3 participants |
| AAB-003 2 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Number of Participants with AEs | 9 participants |
| AAB-003 2 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Number of Participants with SAEs | 2 participants |
| AAB-003 4 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Number of Participants with SAEs | 3 participants |
| AAB-003 4 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Number of Participants with AEs | 5 participants |
| AAB-003 8 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Number of Participants with AEs | 10 participants |
| AAB-003 8 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Number of Participants with SAEs | 1 participants |
| Placebo/AAB-003 | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Number of Participants with AEs | 8 participants |
| Placebo/AAB-003 | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Number of Participants with SAEs | 1 participants |
Other Pre-specified
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Scores at Week 52
ADAS-Cog is a structured scale that evaluates memory, orientation, attention, reasoning, language and constructional praxis. The ADAS-Cog comprises 11 items that are summed to a total score ranging from 0 to 70, with higher scores indicate greater cognitive impairment.
Time frame: Baseline, Week 52
Population: The full analysis set included participants who were randomized and received at least 1 infusion of study medication; n=number of evaluable participants at the specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AAB-003 0.5 mg/kg | Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Scores at Week 52 | Baseline (n=6,3,12,10,12,9) | 12.0 units on a scale | Standard Deviation 4.58 |
| AAB-003 0.5 mg/kg | Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Scores at Week 52 | Change at Week 52 (n=4,3,9,8,10,8) | 3.7 units on a scale | Standard Deviation 3.98 |
| AAB-003 1 mg/kg | Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Scores at Week 52 | Baseline (n=6,3,12,10,12,9) | 22.7 units on a scale | Standard Deviation 11.79 |
| AAB-003 1 mg/kg | Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Scores at Week 52 | Change at Week 52 (n=4,3,9,8,10,8) | 3.0 units on a scale | Standard Deviation 7.22 |
| AAB-003 2 mg/kg | Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Scores at Week 52 | Change at Week 52 (n=4,3,9,8,10,8) | 5.5 units on a scale | Standard Deviation 4.3 |
| AAB-003 2 mg/kg | Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Scores at Week 52 | Baseline (n=6,3,12,10,12,9) | 25.1 units on a scale | Standard Deviation 14.11 |
| AAB-003 4 mg/kg | Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Scores at Week 52 | Baseline (n=6,3,12,10,12,9) | 23.8 units on a scale | Standard Deviation 9.21 |
| AAB-003 4 mg/kg | Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Scores at Week 52 | Change at Week 52 (n=4,3,9,8,10,8) | 2.8 units on a scale | Standard Deviation 4.56 |
| AAB-003 8 mg/kg | Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Scores at Week 52 | Baseline (n=6,3,12,10,12,9) | 19.6 units on a scale | Standard Deviation 10.72 |
| AAB-003 8 mg/kg | Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Scores at Week 52 | Change at Week 52 (n=4,3,9,8,10,8) | 5.9 units on a scale | Standard Deviation 4.22 |
| Placebo/AAB-003 | Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Scores at Week 52 | Change at Week 52 (n=4,3,9,8,10,8) | 2.5 units on a scale | Standard Deviation 6.07 |
| Placebo/AAB-003 | Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Scores at Week 52 | Baseline (n=6,3,12,10,12,9) | 23.3 units on a scale | Standard Deviation 11 |
Other Pre-specified
Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) Scores at Week 52
The CDR scale is a dementia staging instrument that tracks the progression of cognitive impairment in the following 6 categories: memory, orientation, judgment and problem solving, involvement in community affairs, home and hobbies, and personal care. The CDR-SB scale is obtained by summing the ratings in each of the 6 categories, ranging from 0 to 18. Higher scores indicate greater disease severity.
Time frame: Baseline, Week 52
Population: The full analysis set included participants who were randomized and received at least 1 infusion of study medication; n=number of evaluable participants at the specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AAB-003 0.5 mg/kg | Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) Scores at Week 52 | Baseline (n=6,3,12,10,12,9) | 9.00 units on a scale | Standard Deviation 3.347 |
| AAB-003 0.5 mg/kg | Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) Scores at Week 52 | Change at Week 52 (n=4,3,9,8,10,9) | 0.00 units on a scale | Standard Deviation 0.816 |
| AAB-003 1 mg/kg | Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) Scores at Week 52 | Change at Week 52 (n=4,3,9,8,10,9) | 0.33 units on a scale | Standard Deviation 0.577 |
| AAB-003 1 mg/kg | Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) Scores at Week 52 | Baseline (n=6,3,12,10,12,9) | 11.00 units on a scale | Standard Deviation 1 |
| AAB-003 2 mg/kg | Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) Scores at Week 52 | Baseline (n=6,3,12,10,12,9) | 11.33 units on a scale | Standard Deviation 5.71 |
| AAB-003 2 mg/kg | Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) Scores at Week 52 | Change at Week 52 (n=4,3,9,8,10,9) | 2.67 units on a scale | Standard Deviation 2.291 |
| AAB-003 4 mg/kg | Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) Scores at Week 52 | Change at Week 52 (n=4,3,9,8,10,9) | 2.38 units on a scale | Standard Deviation 1.598 |
| AAB-003 4 mg/kg | Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) Scores at Week 52 | Baseline (n=6,3,12,10,12,9) | 10.30 units on a scale | Standard Deviation 4.473 |
| AAB-003 8 mg/kg | Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) Scores at Week 52 | Baseline (n=6,3,12,10,12,9) | 10.33 units on a scale | Standard Deviation 4.313 |
| AAB-003 8 mg/kg | Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) Scores at Week 52 | Change at Week 52 (n=4,3,9,8,10,9) | 1.10 units on a scale | Standard Deviation 2.378 |
| Placebo/AAB-003 | Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) Scores at Week 52 | Change at Week 52 (n=4,3,9,8,10,9) | 2.56 units on a scale | Standard Deviation 2.789 |
| Placebo/AAB-003 | Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) Scores at Week 52 | Baseline (n=6,3,12,10,12,9) | 9.56 units on a scale | Standard Deviation 3.941 |
Other Pre-specified
Change From Baseline in Disability Assessment in Dementia (DAD) at Week 52
The DAD is a functional assessment comprised of 40 items (17 items related to self-care and 23 items involving instrumental activities of daily living). The DAD assessment is scored from 0 to 100; higher scores indicate better function.
Time frame: Baseline, Week 52
Population: The full analysis set included participants who were randomized and received at least 1 infusion of study medication; n=number of evaluable participants at the specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AAB-003 0.5 mg/kg | Change From Baseline in Disability Assessment in Dementia (DAD) at Week 52 | Change at Week 52 (n=4,3,9,8,10,9) | -5.0 units on a scale | Standard Deviation 24.75 |
| AAB-003 0.5 mg/kg | Change From Baseline in Disability Assessment in Dementia (DAD) at Week 52 | Baseline (n=6,3,12,10,12,9) | 83.7 units on a scale | Standard Deviation 12.5 |
| AAB-003 1 mg/kg | Change From Baseline in Disability Assessment in Dementia (DAD) at Week 52 | Baseline (n=6,3,12,10,12,9) | 73.3 units on a scale | Standard Deviation 7.64 |
| AAB-003 1 mg/kg | Change From Baseline in Disability Assessment in Dementia (DAD) at Week 52 | Change at Week 52 (n=4,3,9,8,10,9) | -9.7 units on a scale | Standard Deviation 6.43 |
| AAB-003 2 mg/kg | Change From Baseline in Disability Assessment in Dementia (DAD) at Week 52 | Change at Week 52 (n=4,3,9,8,10,9) | -10.4 units on a scale | Standard Deviation 15.26 |
| AAB-003 2 mg/kg | Change From Baseline in Disability Assessment in Dementia (DAD) at Week 52 | Baseline (n=6,3,12,10,12,9) | 69.5 units on a scale | Standard Deviation 23.82 |
| AAB-003 4 mg/kg | Change From Baseline in Disability Assessment in Dementia (DAD) at Week 52 | Change at Week 52 (n=4,3,9,8,10,9) | -7.5 units on a scale | Standard Deviation 6.72 |
| AAB-003 4 mg/kg | Change From Baseline in Disability Assessment in Dementia (DAD) at Week 52 | Baseline (n=6,3,12,10,12,9) | 72.4 units on a scale | Standard Deviation 27.11 |
| AAB-003 8 mg/kg | Change From Baseline in Disability Assessment in Dementia (DAD) at Week 52 | Baseline (n=6,3,12,10,12,9) | 78.3 units on a scale | Standard Deviation 19.48 |
| AAB-003 8 mg/kg | Change From Baseline in Disability Assessment in Dementia (DAD) at Week 52 | Change at Week 52 (n=4,3,9,8,10,9) | -5.2 units on a scale | Standard Deviation 12.89 |
| Placebo/AAB-003 | Change From Baseline in Disability Assessment in Dementia (DAD) at Week 52 | Change at Week 52 (n=4,3,9,8,10,9) | -14.3 units on a scale | Standard Deviation 20.51 |
| Placebo/AAB-003 | Change From Baseline in Disability Assessment in Dementia (DAD) at Week 52 | Baseline (n=6,3,12,10,12,9) | 81.1 units on a scale | Standard Deviation 16.25 |
Other Pre-specified
Change From Baseline in Mini-Mental State Exam (MMSE) Scores at Week 52
The MMSE is a brief 30-point questionnaire test that is used to assess cognition. Scores range from 0 to 30, with higher scores indicating better cognitive state.
Time frame: Baseline, Week 52
Population: The full analysis set included participants who were randomized and received at least 1 infusion of study medication; n=number of evaluable participants at the specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AAB-003 0.5 mg/kg | Change From Baseline in Mini-Mental State Exam (MMSE) Scores at Week 52 | Baseline (n=6,3,12,10,12,9) | 24.7 units on a scale | Standard Deviation 1.86 |
| AAB-003 0.5 mg/kg | Change From Baseline in Mini-Mental State Exam (MMSE) Scores at Week 52 | Change at Week 52 (n=4,3,9,8,10,9) | -1.0 units on a scale | Standard Deviation 2.94 |
| AAB-003 1 mg/kg | Change From Baseline in Mini-Mental State Exam (MMSE) Scores at Week 52 | Baseline (n=6,3,12,10,12,9) | 21.0 units on a scale | Standard Deviation 4.36 |
| AAB-003 1 mg/kg | Change From Baseline in Mini-Mental State Exam (MMSE) Scores at Week 52 | Change at Week 52 (n=4,3,9,8,10,9) | 1.7 units on a scale | Standard Deviation 1.15 |
| AAB-003 2 mg/kg | Change From Baseline in Mini-Mental State Exam (MMSE) Scores at Week 52 | Baseline (n=6,3,12,10,12,9) | 19.3 units on a scale | Standard Deviation 5.05 |
| AAB-003 2 mg/kg | Change From Baseline in Mini-Mental State Exam (MMSE) Scores at Week 52 | Change at Week 52 (n=4,3,9,8,10,9) | -2.7 units on a scale | Standard Deviation 2.78 |
| AAB-003 4 mg/kg | Change From Baseline in Mini-Mental State Exam (MMSE) Scores at Week 52 | Baseline (n=6,3,12,10,12,9) | 18.5 units on a scale | Standard Deviation 4.86 |
| AAB-003 4 mg/kg | Change From Baseline in Mini-Mental State Exam (MMSE) Scores at Week 52 | Change at Week 52 (n=4,3,9,8,10,9) | -2.1 units on a scale | Standard Deviation 1.64 |
| AAB-003 8 mg/kg | Change From Baseline in Mini-Mental State Exam (MMSE) Scores at Week 52 | Baseline (n=6,3,12,10,12,9) | 21.3 units on a scale | Standard Deviation 5.4 |
| AAB-003 8 mg/kg | Change From Baseline in Mini-Mental State Exam (MMSE) Scores at Week 52 | Change at Week 52 (n=4,3,9,8,10,9) | -2.0 units on a scale | Standard Deviation 2.16 |
| Placebo/AAB-003 | Change From Baseline in Mini-Mental State Exam (MMSE) Scores at Week 52 | Baseline (n=6,3,12,10,12,9) | 18.9 units on a scale | Standard Deviation 5.64 |
| Placebo/AAB-003 | Change From Baseline in Mini-Mental State Exam (MMSE) Scores at Week 52 | Change at Week 52 (n=4,3,9,8,10,9) | -1.7 units on a scale | Standard Deviation 3.91 |
Other Pre-specified
Change From Baseline in Neuropsychiatric Inventory (NPI) Behavioral Symptoms at Week 52
The NPI is an instrument used to assess changes of behavior that have appeared in a defined period of time in subjects with Alzheimer's Disease and other dementias. Twelve behavioral areas are assessed: delusions, apathy, hallucinations, disinhibition, agitation, irritability, depression, aberrant motor behavior, anxiety, nighttime behaviors, euphoria, appetite, and eating changes. The NPI score is based on frequency and severity of specific behaviors within these categories. Severity (1=Mild to 3=Severe), frequency (1=occasionally to 4=very frequently) scales recorded for each domain; frequency\*severity=each domain score (range 0-12). Total score=sum of each domain score (range 0-144); higher score=greater behavioral disturbances; negative change score from baseline=improvement.
Time frame: Baseline, Week 52
Population: The full analysis set included participants who were randomized and received at least 1 infusion of study medication; n=number of evaluable participants at the specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AAB-003 0.5 mg/kg | Change From Baseline in Neuropsychiatric Inventory (NPI) Behavioral Symptoms at Week 52 | Baseline (n=6,3,12,10,12,9) | 11.2 units on a scale | Standard Deviation 7.65 |
| AAB-003 0.5 mg/kg | Change From Baseline in Neuropsychiatric Inventory (NPI) Behavioral Symptoms at Week 52 | Change at Week 52 (n=4,3,9,8,10,9) | -3.5 units on a scale | Standard Deviation 4.36 |
| AAB-003 1 mg/kg | Change From Baseline in Neuropsychiatric Inventory (NPI) Behavioral Symptoms at Week 52 | Change at Week 52 (n=4,3,9,8,10,9) | 5.7 units on a scale | Standard Deviation 1.15 |
| AAB-003 1 mg/kg | Change From Baseline in Neuropsychiatric Inventory (NPI) Behavioral Symptoms at Week 52 | Baseline (n=6,3,12,10,12,9) | 12.0 units on a scale | Standard Deviation 13.45 |
| AAB-003 2 mg/kg | Change From Baseline in Neuropsychiatric Inventory (NPI) Behavioral Symptoms at Week 52 | Change at Week 52 (n=4,3,9,8,10,9) | 5.1 units on a scale | Standard Deviation 8.39 |
| AAB-003 2 mg/kg | Change From Baseline in Neuropsychiatric Inventory (NPI) Behavioral Symptoms at Week 52 | Baseline (n=6,3,12,10,12,9) | 7.1 units on a scale | Standard Deviation 6.99 |
| AAB-003 4 mg/kg | Change From Baseline in Neuropsychiatric Inventory (NPI) Behavioral Symptoms at Week 52 | Baseline (n=6,3,12,10,12,9) | 11.0 units on a scale | Standard Deviation 16.73 |
| AAB-003 4 mg/kg | Change From Baseline in Neuropsychiatric Inventory (NPI) Behavioral Symptoms at Week 52 | Change at Week 52 (n=4,3,9,8,10,9) | 4.5 units on a scale | Standard Deviation 8.9 |
| AAB-003 8 mg/kg | Change From Baseline in Neuropsychiatric Inventory (NPI) Behavioral Symptoms at Week 52 | Change at Week 52 (n=4,3,9,8,10,9) | 0.1 units on a scale | Standard Deviation 12.54 |
| AAB-003 8 mg/kg | Change From Baseline in Neuropsychiatric Inventory (NPI) Behavioral Symptoms at Week 52 | Baseline (n=6,3,12,10,12,9) | 9.6 units on a scale | Standard Deviation 10.24 |
| Placebo/AAB-003 | Change From Baseline in Neuropsychiatric Inventory (NPI) Behavioral Symptoms at Week 52 | Change at Week 52 (n=4,3,9,8,10,9) | 13.9 units on a scale | Standard Deviation 23 |
| Placebo/AAB-003 | Change From Baseline in Neuropsychiatric Inventory (NPI) Behavioral Symptoms at Week 52 | Baseline (n=6,3,12,10,12,9) | 3.9 units on a scale | Standard Deviation 3.92 |
Other Pre-specified
Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer
Number of participants with positive sample(s) in the ADA assay and in the neutralizing anti-drug antibodies (NAb) assay. An endpoint titer \>=6.64 corresponded to positive ADA category value. The number of participants who tested positive on 1 or more occasions is reported.
Time frame: Baseline, Week 52
Population: The safety analysis set included participants who received at least 1 infusion of study medication (including partial infusions); n=number of evaluable participants at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AAB-003 0.5 mg/kg | Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer | Week 52 (n=4,3,9,8,10,8) | 0 participants |
| AAB-003 0.5 mg/kg | Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer | Baseline (n=6,3,12,10,8) | 0 participants |
| AAB-003 1 mg/kg | Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer | Week 52 (n=4,3,9,8,10,8) | 0 participants |
| AAB-003 1 mg/kg | Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer | Baseline (n=6,3,12,10,8) | 0 participants |
| AAB-003 2 mg/kg | Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer | Week 52 (n=4,3,9,8,10,8) | 0 participants |
| AAB-003 2 mg/kg | Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer | Baseline (n=6,3,12,10,8) | 0 participants |
| AAB-003 4 mg/kg | Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer | Week 52 (n=4,3,9,8,10,8) | 0 participants |
| AAB-003 4 mg/kg | Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer | Baseline (n=6,3,12,10,8) | 0 participants |
| AAB-003 8 mg/kg | Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer | Baseline (n=6,3,12,10,8) | 0 participants |
| AAB-003 8 mg/kg | Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer | Week 52 (n=4,3,9,8,10,8) | 0 participants |
| Placebo/AAB-003 | Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer | Week 52 (n=4,3,9,8,10,8) | 0 participants |
| Placebo/AAB-003 | Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer | Baseline (n=6,3,12,10,8) | 0 participants |