Phase 2 Study of BIIB092 in Participants With Early Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: BIIB092; Placebo
Intervention description: Administered as specified in treatment arm.; Administered as specified in treatment arm.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 654.0
Sex: All
Minimum age: 50 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Mild cognitive impairment; Alzheimer's disease

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.
    

Eligibility 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/Exclusion criteria may apply