Start: May 3, 2018
End: August 2021
Enrollment: 528
What Is This Study About?
The study will evaluate BIIB092, a monoclonal antibody, in people with mild cognitive impairment (MCI) due to Alzheimer's disease or mild Alzheimer's disease.
Do I Qualify To Participate in This Study?
Must have:
- Gradual, progressive change in memory function during more than 6 months
- MCI due to Alzheimer's disease or mild Alzheimer's disease
- Objective evidence of cognitive impairment, as shown by Clinical Dementia Rating (CDR) Scale score of 0.5 for MCI or 0.5 or 1 for mild Alzheimer's, Mini-Mental State Examination score of 22-30 (inclusive), and CDR Memory Box score of 0.5
- Consent to apolipoprotein E (ApoE) genotyping
- Informant/study partner
- Beta-amyloid positivity confirmed at screening
Must NOT have:
- Any medical or neurological/neurodegenerative condition other than Alzheimer's
- Clinically significant, unstable psychiatric illness
- Stroke, mini-stroke, or unexplained loss of consciousness during the past year
- Brain hemorrhage, bleeding disorder, or cerebrovascular abnormalities
- History of unstable angina, heart attack, chronic heart failure, or clinically significant conduction abnormalities during the past year
- Impaired renal or liver function
- Alcohol or substance abuse during the past year
- Significant illness or infection during the past year
- Unstable medication dosing for chronic conditions during the past 4 weeks
- Unstable medication dosing for Alzheimer's disease during the past 8 weeks
- Any medication use that may contribute to cognitive impairment or increase risk for adverse events
If I Qualify, Who Do I Contact?
Contact study personnel listed either under the general study contact or the location nearest you.
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?
Lead: Biogen
Source: ClinicalTrials.gov ID: NCT03352557