Alzheimer's Disease
Conditions
Keywords
Mild cognitive impairment, Alzheimer's disease
Brief summary
The primary objective of the placebo-controlled period is to evaluate the safety and tolerability of BIIB092 in participants with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or with mild AD. The secondary objectives of the placebo-controlled period are to evaluate the efficacy of multiple doses of BIIB092 in slowing cognitive and functional impairment in participants with MCI due to AD or with mild AD, and to evaluate the immunogenicity of BIIB092 after multiple doses in participants with MCI due to AD or with mild AD. The primary objective of the long-term extension period is to evaluate the long-term safety and tolerability of BIIB092 in participants with MCI due to AD or with mild AD.
Interventions
DRUGBIIB092
Administered as specified in treatment arm.
DRUGPlacebo
Administered as specified in treatment arm.
Sponsors
Biogen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Must have a gradual and progressive change in memory function over more than 6 months. * Must meet all of the clinical criteria for mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild AD and must have * Objective evidence of cognitive impairment at Screening * Clinical Dementia Rating Scale (CDR) global score of 0.5 for MCI due to AD or 0.5 or 1 for mild AD * Mini-Mental State Examination (MMSE) score of 22 to 30 (inclusive) * CDR Memory Box score of ≥0.5 * Must consent to apolipoprotein E (ApoE) genotyping * Must have 1 informant/study partner * Must have amyloid beta positivity confirmed at Screening Key
Exclusion criteria
* Any medical or neurological/neurodegenerative condition (other than AD) that, in the opinion of the Investigator, might be a contributing cause to the participant's cognitive impairment or could lead to discontinuation, lack of compliance, interference with study assessments, or safety concerns * Clinically significant, unstable psychiatric illness * Have had a stroke or Transient Ischemic Attack (TIA) or unexplained loss of consciousness in the past 1 year * Relevant brain hemorrhage, bleeding disorder and cerebrovascular abnormalities * History of unstable angina, myocardial infarction, chronic heart failure or clinically significant conduction abnormalities within 1 year prior to Screening Visit 1 * Indication of impaired renal or liver function * Alcohol or substance abuse in past 1 year * Clinically significant systemic illness or serious infection within 30 days prior to or during the screening period * Use of allowed medications for chronic conditions at doses that have not been stable for at least 4 weeks prior to Screening Visit 1 and during the screening period up to Study Day 1, or use of AD medications at doses that have not been stable for at least 8 weeks prior to Screening Visit 1 and during the screening period up to Study Day 1. * Use of any medications that, in the opinion of the Investigator, may contribute to cognitive impairment, put the participants at higher risk for adverse events (AEs), or impair the participant's ability to perform cognitive testing or complete study procedures. * Contraindications to study procedures NOTE: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PC Period: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Day 1 to Week 78 (participants who entered LTE period); Day 1 up to Week 90 (participants who did not LTE period) | AE is any untoward medical occurrence in participant or clinical investigation participant administered pharmaceutical product and that does not necessarily have causal relationship with this treatment. AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of medicinal (investigational) product, whether or not related to medicinal (investigational) product. SAE is any untoward medical occurrence that at any dose, results in death; in view of investigator places participant at immediate risk of death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in congenital anomaly/birth defect; is medically important event. Participants who completed treatment period in PC period and did not enter LTE period were to be assessed at Week 90 (14 weeks after end of treatment) as safety follow-up. |
| LTE Period: Percentage of Participants With AEs and SAEs | From Week 80 to Week 173 | An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose, results in death; in the view of the investigator places the participant at immediate risk of death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; is a medically important event. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PC Period: Change From Baseline Over Time at Week 78 on the Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) Score | Baseline, Week 78 | The CDR-SB is a validated clinical assessment of global function in participants with AD. The CDR is comprised of 6 domains: Memory, Orientation, Judgment and Problem Solving, Community Affairs, Home and Hobbies, and Personal Care. CDR-SB is the sum of the scores for these 6 domains. Impairment is scored in each of 6 cognitive categories on a scale in which none = 0, questionable = 0.5, mild = 1, moderate = 2, and severe = 3. The 6 individual category ratings, or box scores, can be added together to give the CDR-SB score which ranges from 0 (none) to 18 (severe impairment). |
| PC Period: Percentage of Participants With Anti-BIIB092 Antibodies in Serum | Baseline up to Week 76 | — |
Countries
Australia, France, Germany, Italy, Japan, Poland, Spain, Sweden, United States
Participant flow
Recruitment details
Participants were enrolled at approximately 100 investigational sites from 03 May 2018 to 30 August 2021.
Pre-assignment details
A total of 654 participants with Alzheimer's Disease (AD) were enrolled and randomized to receive placebo or BIIB092 125/375/600/2000 milligrams(mg) in Placebo-Controlled (PC) period. Following PC period, 521 participants entered and 516 were dosed in Long-term Extension (LTE) period, and no participants completed the study due to early termination of the study. WBP/G=Withdrawal by Parent/Guardian
Participants by arm
| Arm | Count |
|---|---|
| PC Period: Placebo Participants received BIIB092-matching placebo, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period. | 214 |
| PC Period: BIIB092 125 mg/4 Week Participants received BIIB092, 125 mg, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period. | 58 |
| PC Period: BIIB092 375 mg/12 Week Participants received BIIB092, 375 mg, IV infusion, on Day 1 and then once every 12 weeks for 76 weeks during the PC period. | 58 |
| PC Period: BIIB092 600 mg/4 Week Participants received BIIB092, 600 mg, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period. | 106 |
| PC Period: BIIB092 2000 mg/4 Week Participants received BIIB092, 2000 mg, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period. | 218 |
| Total | 654 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| LTE Period: Week 80 to Week 173 | Adverse Event | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 0 |
| LTE Period: Week 80 to Week 173 | Death | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 1 | 1 |
| LTE Period: Week 80 to Week 173 | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 1 |
| LTE Period: Week 80 to Week 173 | Other | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| LTE Period: Week 80 to Week 173 | Physician Decision | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 |
| LTE Period: Week 80 to Week 173 | Progressive Disease | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 0 |
| LTE Period: Week 80 to Week 173 | Site Terminated by Sponsor | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 |
| LTE Period: Week 80 to Week 173 | Study Terminated by Sponsor | 0 | 0 | 0 | 0 | 0 | 38 | 49 | 75 | 151 | 154 |
| LTE Period: Week 80 to Week 173 | WBP/G-Concern About Study Procedures/Perceived Risks | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| LTE Period: Week 80 to Week 173 | WBP/G-Other | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 2 | 0 |
| LTE Period: Week 80 to Week 173 | WBP/G-Relocation (Moving or Has Moved) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 |
| LTE Period: Week 80 to Week 173 | WBP/G-Study Visit Burden/Scheduling Conflicts | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 1 |
| LTE Period: Week 80 to Week 173 | WBP/G-Unable to Continue to Enable Participation due to Illness/Hospitalization/Death | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 0 |
| LTE Period: Week 80 to Week 173 | Withdrawal by Participant-Other | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 1 | 4 |
| LTE Period: Week 80 to Week 173 | Withdrawal by Participant-Relocation (Moving or Has Moved) | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 1 | 0 |
| LTE Period: Week 80 to Week 173 | Withdrawal by Participant-Study Visit Burden/Scheduling Conflicts | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 5 | 3 | 3 |
| PC Period: Day 1 to Week 78 | Adverse Event | 10 | 1 | 1 | 0 | 5 | 0 | 0 | 0 | 0 | 0 |
| PC Period: Day 1 to Week 78 | Death | 1 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| PC Period: Day 1 to Week 78 | Lost to Follow-up | 1 | 0 | 1 | 0 | 2 | 0 | 0 | 0 | 0 | 0 |
| PC Period: Day 1 to Week 78 | Noncompliance with Study Drug | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| PC Period: Day 1 to Week 78 | Not Dosed | 0 | 0 | 0 | 0 | 4 | 0 | 0 | 0 | 0 | 0 |
| PC Period: Day 1 to Week 78 | Other | 5 | 1 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 0 |
| PC Period: Day 1 to Week 78 | Physician Decision-Unrelated to Safety | 2 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| PC Period: Day 1 to Week 78 | Progressive Disease | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| PC Period: Day 1 to Week 78 | Protocol Deviation | 1 | 0 | 0 | 1 | 2 | 0 | 0 | 0 | 0 | 0 |
| PC Period: Day 1 to Week 78 | Randomized by Mistake | 2 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| PC Period: Day 1 to Week 78 | Site Terminated by Sponsor | 2 | 1 | 1 | 1 | 2 | 0 | 0 | 0 | 0 | 0 |
| PC Period: Day 1 to Week 78 | WBP/G-Concern About Study Procedures/Perceived Risks | 1 | 0 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 |
| PC Period: Day 1 to Week 78 | WBP/G-Desire for Change in Treatment (Unrelated to Safety) | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| PC Period: Day 1 to Week 78 | WBP/G-Other | 0 | 2 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 0 |
| PC Period: Day 1 to Week 78 | WBP/G-Study Visit Burden/Scheduling Conflicts | 0 | 0 | 0 | 1 | 3 | 0 | 0 | 0 | 0 | 0 |
| PC Period: Day 1 to Week 78 | WBP/G-Unable to Continue to Enable Participation due to Illness/Hospitalization/Death | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| PC Period: Day 1 to Week 78 | Withdrawal by Participant-Concern About Study Procedures/Perceived Risks | 1 | 0 | 0 | 1 | 2 | 0 | 0 | 0 | 0 | 0 |
| PC Period: Day 1 to Week 78 | Withdrawal by Participant-Desire for Change in Treatment (Unrelated to Safety) | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| PC Period: Day 1 to Week 78 | Withdrawal by Participant-Other | 6 | 2 | 2 | 5 | 7 | 0 | 0 | 0 | 0 | 0 |
| PC Period: Day 1 to Week 78 | Withdrawal by Participant-Relocation (Moving or Has Moved) | 1 | 1 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 |
| PC Period: Day 1 to Week 78 | Withdrawal by Participant-Study Visit Burden/Scheduling Conflicts | 7 | 1 | 1 | 0 | 5 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | PC Period: Placebo | PC Period: BIIB092 125 mg/4 Week | PC Period: BIIB092 375 mg/12 Week | PC Period: BIIB092 600 mg/4 Week | PC Period: BIIB092 2000 mg/4 Week | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 69.8 years STANDARD_DEVIATION 6.63 | 70.4 years STANDARD_DEVIATION 6.8 | 70.3 years STANDARD_DEVIATION 6.79 | 69.7 years STANDARD_DEVIATION 6.66 | 69.4 years STANDARD_DEVIATION 7.11 | 69.7 years STANDARD_DEVIATION 6.81 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 2 Participants | 2 Participants | 1 Participants | 9 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 208 Participants | 53 Participants | 55 Participants | 103 Participants | 208 Participants | 627 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 3 Participants | 1 Participants | 2 Participants | 1 Participants | 10 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 3 Participants | 2 Participants | 6 Participants | 7 Participants | 23 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 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 |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 2 Participants | 2 Participants | 1 Participants | 4 Participants | 12 Participants |
| Race (NIH/OMB) White | 201 Participants | 53 Participants | 53 Participants | 98 Participants | 206 Participants | 611 Participants |
| Sex: Female, Male Female | 106 Participants | 28 Participants | 26 Participants | 55 Participants | 114 Participants | 329 Participants |
| Sex: Female, Male Male | 108 Participants | 30 Participants | 32 Participants | 51 Participants | 104 Participants | 325 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 | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 214 | 1 / 58 | 0 / 58 | 0 / 106 | 1 / 214 | 2 / 45 | 0 / 49 | 1 / 89 | 1 / 168 | 1 / 165 |
| other Total, other adverse events | 121 / 214 | 39 / 58 | 38 / 58 | 68 / 106 | 139 / 214 | 10 / 45 | 11 / 49 | 19 / 89 | 28 / 168 | 29 / 165 |
| serious Total, serious adverse events | 26 / 214 | 6 / 58 | 6 / 58 | 13 / 106 | 25 / 214 | 5 / 45 | 1 / 49 | 9 / 89 | 10 / 168 | 13 / 165 |
Outcome results
Primary
LTE Period: Percentage of Participants With AEs and SAEs
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose, results in death; in the view of the investigator places the participant at immediate risk of death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; is a medically important event.
Time frame: From Week 80 to Week 173
Population: The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PC Period: Placebo | LTE Period: Percentage of Participants With AEs and SAEs | AEs | 68.9 percentage of participants |
| PC Period: Placebo | LTE Period: Percentage of Participants With AEs and SAEs | SAEs | 11.1 percentage of participants |
| PC Period: BIIB092 125 mg/4 Week | LTE Period: Percentage of Participants With AEs and SAEs | SAEs | 2.0 percentage of participants |
| PC Period: BIIB092 125 mg/4 Week | LTE Period: Percentage of Participants With AEs and SAEs | AEs | 55.1 percentage of participants |
| PC Period: BIIB092 375 mg/12 Week | LTE Period: Percentage of Participants With AEs and SAEs | SAEs | 10.1 percentage of participants |
| PC Period: BIIB092 375 mg/12 Week | LTE Period: Percentage of Participants With AEs and SAEs | AEs | 58.4 percentage of participants |
| PC Period: BIIB092 600 mg/4 Week | LTE Period: Percentage of Participants With AEs and SAEs | AEs | 61.3 percentage of participants |
| PC Period: BIIB092 600 mg/4 Week | LTE Period: Percentage of Participants With AEs and SAEs | SAEs | 6.0 percentage of participants |
| PC Period: BIIB092 2000 mg/4 Week | LTE Period: Percentage of Participants With AEs and SAEs | SAEs | 7.9 percentage of participants |
| PC Period: BIIB092 2000 mg/4 Week | LTE Period: Percentage of Participants With AEs and SAEs | AEs | 60.0 percentage of participants |
Primary
PC Period: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AE is any untoward medical occurrence in participant or clinical investigation participant administered pharmaceutical product and that does not necessarily have causal relationship with this treatment. AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of medicinal (investigational) product, whether or not related to medicinal (investigational) product. SAE is any untoward medical occurrence that at any dose, results in death; in view of investigator places participant at immediate risk of death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in congenital anomaly/birth defect; is medically important event. Participants who completed treatment period in PC period and did not enter LTE period were to be assessed at Week 90 (14 weeks after end of treatment) as safety follow-up.
Time frame: Day 1 to Week 78 (participants who entered LTE period); Day 1 up to Week 90 (participants who did not LTE period)
Population: The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PC Period: Placebo | PC Period: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 84.6 percentage of participants |
| PC Period: Placebo | PC Period: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 12.1 percentage of participants |
| PC Period: BIIB092 125 mg/4 Week | PC Period: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 86.2 percentage of participants |
| PC Period: BIIB092 125 mg/4 Week | PC Period: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 10.3 percentage of participants |
| PC Period: BIIB092 375 mg/12 Week | PC Period: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 82.8 percentage of participants |
| PC Period: BIIB092 375 mg/12 Week | PC Period: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 10.3 percentage of participants |
| PC Period: BIIB092 600 mg/4 Week | PC Period: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 12.3 percentage of participants |
| PC Period: BIIB092 600 mg/4 Week | PC Period: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 88.7 percentage of participants |
| PC Period: BIIB092 2000 mg/4 Week | PC Period: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 88.3 percentage of participants |
| PC Period: BIIB092 2000 mg/4 Week | PC Period: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 11.7 percentage of participants |
Secondary
PC Period: Change From Baseline Over Time at Week 78 on the Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) Score
The CDR-SB is a validated clinical assessment of global function in participants with AD. The CDR is comprised of 6 domains: Memory, Orientation, Judgment and Problem Solving, Community Affairs, Home and Hobbies, and Personal Care. CDR-SB is the sum of the scores for these 6 domains. Impairment is scored in each of 6 cognitive categories on a scale in which none = 0, questionable = 0.5, mild = 1, moderate = 2, and severe = 3. The 6 individual category ratings, or box scores, can be added together to give the CDR-SB score which ranges from 0 (none) to 18 (severe impairment).
Time frame: Baseline, Week 78
Population: FAS included all randomized participants who received study treatment (BIIB092 or placebo). As pre-specified in study protocol, 125 mg and 375 mg groups were pooled as 'Low dose' group for efficacy analyses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PC Period: Placebo | PC Period: Change From Baseline Over Time at Week 78 on the Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) Score | Baseline | 3.07 score on a scale | Standard Deviation 1.467 |
| PC Period: Placebo | PC Period: Change From Baseline Over Time at Week 78 on the Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) Score | Change at Week 78 | 1.71 score on a scale | Standard Deviation 2.376 |
| PC Period: BIIB092 125 mg/4 Week | PC Period: Change From Baseline Over Time at Week 78 on the Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) Score | Change at Week 78 | 2.10 score on a scale | Standard Deviation 2.375 |
| PC Period: BIIB092 125 mg/4 Week | PC Period: Change From Baseline Over Time at Week 78 on the Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) Score | Baseline | 2.92 score on a scale | Standard Deviation 1.62 |
| PC Period: BIIB092 375 mg/12 Week | PC Period: Change From Baseline Over Time at Week 78 on the Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) Score | Baseline | 3.24 score on a scale | Standard Deviation 1.557 |
| PC Period: BIIB092 375 mg/12 Week | PC Period: Change From Baseline Over Time at Week 78 on the Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) Score | Change at Week 78 | 2.23 score on a scale | Standard Deviation 2.987 |
| PC Period: BIIB092 600 mg/4 Week | PC Period: Change From Baseline Over Time at Week 78 on the Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) Score | Baseline | 3.04 score on a scale | Standard Deviation 1.378 |
| PC Period: BIIB092 600 mg/4 Week | PC Period: Change From Baseline Over Time at Week 78 on the Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) Score | Change at Week 78 | 1.76 score on a scale | Standard Deviation 2.038 |
Secondary
PC Period: Percentage of Participants With Anti-BIIB092 Antibodies in Serum
Time frame: Baseline up to Week 76
Population: The ADA evaluable set is defined as participants in the FAS who have an evaluable postbaseline ADA sample.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PC Period: Placebo | PC Period: Percentage of Participants With Anti-BIIB092 Antibodies in Serum | 1.9 percentage of participants |
| PC Period: BIIB092 125 mg/4 Week | PC Period: Percentage of Participants With Anti-BIIB092 Antibodies in Serum | 0 percentage of participants |
| PC Period: BIIB092 375 mg/12 Week | PC Period: Percentage of Participants With Anti-BIIB092 Antibodies in Serum | 0 percentage of participants |
| PC Period: BIIB092 600 mg/4 Week | PC Period: Percentage of Participants With Anti-BIIB092 Antibodies in Serum | 1.0 percentage of participants |
| PC Period: BIIB092 2000 mg/4 Week | PC Period: Percentage of Participants With Anti-BIIB092 Antibodies in Serum | 0 percentage of participants |