221AD302 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer's Disease

Overview

About this study

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].

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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)

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Jacksonville, Fla. Mayo Clinic principal investigator Neill Graff Radford, M.D.	Closed for enrollment

Mayo Clinic Location

Status

Jacksonville, Fla.

Mayo Clinic principal investigator

Neill Graff Radford, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Clinical Trials