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ENGAGE: Aducanumab (BIIB037) for Early Alzheimer's Disease
Start: June 2015
End: August 2019
Enrollment: 1350
What Is This Study About?
The primary objective of this Phase III study is to evaluate the efficacy of the experimental drug aducanumab (BIIB037), compared with a placebo, in slowing cognitive and functional impairment in people with early-stage Alzheimer's disease. Participants will receive monthly infusions.
Do I Qualify To Participate in This Study?
Minimum Age: 55 Years
Maximum Age: 85 Years
Must have:
- Must meet clinical criteria for mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's
- Clinical Dementia Rating-Global Score of 0.5
- Objective evidence of cognitive impairment at screening
- Mini-Mental State Examination score of 24-30 (inclusive)
- Positive amyloid positron emission tomography (PET) scan
- Consent to apolipoprotein E genotyping
- If taking Alzheimer's medications, dose must be stable for at least 8 weeks prior to first screening visit
- Reliable informant or caregiver
Must NOT have:
- Any medical or neurological condition (other than Alzheimer's disease) that might contribute to cognitive impairment
- Stroke, transient ischemic attack (TIA), or unexplained loss of consciousness in the past year
- Clinically significant psychiatric illness in the past 6 months
- History of unstable angina, myocardial infarction, advanced chronic heart failure, or clinically significant conduction abnormalities within 1 year prior to screening
- Impaired renal or liver function
- Human immunodeficiency virus (HIV) infection
- Significant systematic illness or infection in the past 30 days
- Relevant brain hemorrhage, bleeding disorder, or cerebrovascular abnormalities
- Any contraindication to brain scans
- Alcohol or substance abuse in the past year
- Taking blood thinner medication (except for aspirin at a prophylactic dose or less)
If I Qualify, Who Do I Contact?
Contact study personnel listed either under the general study contact or the location nearest you.
Who Is the General Study Contact?
For more information about this study or study sites, contact the Aducanumab US Call Center at 877-231-7271 or clinicaltrials@biogen.com.
Need Help?
Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.
Where Is This Study Located?
Source: ClinicalTrials.gov ID: NCT02477800
An official website of the U.S. government, managed by the National Institutes on Aging at the National Institutes of Health