A Study of Aducanumab in Participants With Mild Cognitive Impairment Due to Alzheimer's Disease or With Mild Alzheimer's Disease Dementia to Evaluate the Safety of Continued Dosing in Participants With Asymptomatic Amyloid-Related Imaging Abnormalities
Condition: Cognitive Dysfunction; Alzheimer's Disease
MeSH terms: Alzheimer Disease; Dementia; Cognitive Dysfunction
Intervention: Aducanumab; Placebo
Intervention description: Administered as specified in the treatment arm.; Administered as specified in the 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: 52.0
Sex: All
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Aducanumab; BIIB037

Summary:

      The primary objective of the study is to assess the safety impact of continuing aducanumab
      dosing in asymptomatic Amyloid-related Imaging Abnormalities (ARIA) in participants with mild
      cognitive impairment (MCI) due to Alzheimer's disease (AD) or with mild AD dementia. The
      secondary objective of the study is to characterize ARIA, from both the imaging and the
      clinical perspective and to characterize the safety, tolerability, pharmacokinetics (PK), and
      immunogenicity of aducanumab.
    

Eligibility criteria:

        Inclusion/ Exclusion Criteria

        Key Inclusion Criteria:

          -  Ability of the participant or his/her legally authorized representative to understand
             the purpose and risks of the study and provide signed and dated informed consent and
             authorization to use confidential health information in accordance with national and
             local participant privacy regulations.

          -  Must have at least 6 years of education or work experience to exclude mental deficits
             other than MCI due to AD or mild AD dementia.

          -  Must have evidence of cerebral Aβ accumulation, based on a positive PET scan of the
             brain. Previously obtained positron emission tomography (PET) scan (within 12 months
             of screening) is permissible. Previous PET scan images must be submitted to the
             central imaging vendor to confirm that study inclusion criteria are met.

          -  Must consent to apolipoprotein E (ApoE) genotyping.

          -  Must meet all of the following clinical criteria for MCI due to AD or mild AD dementia
             according to NIA-AA criteria [Albert 2011; McKhann 2011], and must have the following:
             MCI due to AD (a CDR global score of 0.5, and an MMSE score between 24 and 30
             (inclusive)), or Mild AD dementia (a CDR global score of 0.5 or 1, and as MMSE score
             between 20 and 26 (inclusive)).

        Key Exclusion Criteria:

          -  Any uncontrolled medical or neurological/neurodegenerative condition (other than AD)
             that, in the opinion of the Investigator, might be a contributing cause of the
             participant's cognitive impairment (e.g., substance abuse, vitamin B12 deficiency,
             abnormal thyroid function, stroke or other cerebrovascular condition, Lewy body
             dementia, frontotemporal dementia, head trauma).

          -  Clinically significant unstable psychiatric illness (e.g., uncontrolled major
             depression, uncontrolled schizophrenia, uncontrolled bipolar affective disorder)
             within 6 months prior to Screening.

          -  Transient ischemic attack or stroke or any unexplained loss of consciousness within 1
             year prior to Screening.

          -  Vaccinations within 10 days prior to randomization (Day 1).

          -  Female participants who are pregnant or currently breastfeeding.

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply