Central States Research | Tulsa, OK
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About
The primary objective of this study is to verify the clinical benefit of monthly doses of aducanumab in slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score as compared with placebo in participants with early Alzheimer's disease.
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Inclusion and exclusion criteria
Key Inclusion Criteria:
The participant must have confirmed amyloid beta pathology by cerebrospinal fluid (CSF) or amyloid PET
Must have history of subjective memory decline with gradual onset and slow progression over the 6 months before Screening, confirmed by study partner
The participant must have 1 informant/care partner who, in the Investigator's opinion, has frequent and sufficient contact with the participant (at least 10 hours/week in person or by phone) as to be able to provide accurate information about the participant's cognitive and functional abilities over time
Must meet all of the following clinical criteria for MCI due to Alzheimer's disease or mild Alzheimer's disease according to National Institute on Aging and Alzheimer's Association (NIA-AA) criteria
Apart from a clinical diagnosis of early Alzheimer's disease, the participant must be in good health as determined by the Investigator based on medical history and screening assessments
Must consent to apolipoprotein E (ApoE) genotyping. (Note: Participants are not required to be ApoE ε4 carriers)
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Primary purpose
Allocation
Interventional model
Masking
1,027 participants in 2 patient groups, including a placebo group
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Central trial contact
Global Biogen Clinical Trial Center; US Biogen Clinical Trial Center
Data sourced from clinicaltrials.gov
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