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

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 500

Inclusion 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 Aß 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 NIAAA 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)), and Mild AD dementia (a CDR global score of 0.5 or 1, and as MMSE score between 20 and 26 (inclusive)).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

Exclusion Criteria

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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