221AD301 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Aducanumab (BIIB037); Aducanumab (BIIB037); Placebo
Intervention description: Low dose; High dose; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1653.0
Sex: All
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: BIIB037; Aducanumab

Summary:

      The primary objective of the study is to evaluate the efficacy of monthly doses of aducanumab
      in slowing cognitive and functional impairment as measured by changes in the Clinical
      Dementia Rating-Sum of Boxes (CDR-SB) score as compared with placebo in participants with
      early AD. Secondary objectives are to assess the effect of monthly doses of aducanumab as
      compared with placebo on clinical progression as measured by Mini-Mental State Examination
      (MMSE), AD Assessment Scale-Cognitive Subscale (13 items) [ADAS-Cog 13], and AD Cooperative
      Study-Activities of Daily Living Inventory (Mild Cognitive Impairment version)
      [ADCS-ADL-MCI].
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Must meet all of the following clinical criteria for MCI due to AD or mild AD and must
             have:

          -  A Clinical Dementia Rating (CDR)-Global Score of 0.5.

          -  Objective evidence of cognitive impairment at screening

          -  An MMSE score between 24 and 30 (inclusive)

          -  Must have a positive amyloid Positron Emission Tomography (PET) scan

          -  Must consent to apolipoprotein E (ApoE) genotyping

          -  If using drugs to treat symptoms related to AD, doses must be stable for at least 8
             weeks prior to screening visit 1

          -  Must have a reliable informant or caregiver

        Key Exclusion Criteria:

          -  Any medical or neurological condition (other than Alzheimer's Disease) that might be a
             contributing cause of the subject's cognitive impairment

          -  Have had a stroke or Transient Ischemic Attack (TIA) or unexplained loss of
             consciousness in the past 1 year

          -  Clinically significant unstable psychiatric illness in past 6 months

          -  History of unstable angina, myocardial infarction, advanced chronic heart failure, or
             clinically significant conduction abnormalities within 1 year prior to Screening

          -  Indication of impaired renal or liver function

          -  Have human immunodeficiency virus (HIV) infection

          -  Have a significant systematic illness or infection in past 30 days

          -  Relevant brain hemorrhage, bleeding disorder and cerebrovascular abnormalities

          -  Any contraindications to brain magnetic resonance imaging (MRI) or PET scans

          -  Alcohol or substance abuse in past 1 year

          -  Taking blood thinners (except for aspirin at a prophylactic dose or less)

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply