A Randomized, Double-Blinded, Placebo-Controlled Multiple Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB037 in Subjects With Prodromal or Mild Alzheimer's Disease
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- STATUS
- Recruiting
Summary
A Randomized, Double-Blinded, Placebo-Controlled Multiple Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB037 in Subjects With Prodromal or Mild Alzheimer's Disease
Description
Patient Inclusion Criteria:
- Ages: over 55-90
- Male/Female
- 12 Month Long Clinical Trial
- MMSE score 24-30/20-26
- Subjects must meet criteria for Prodromal AD or Mild AD:
- Mini Mental State Examination (MMSE) score between 20-30
- Clinical Dementia Rating Scale (CDR) score of 0.5 or 1
- a free recall score of lesser or equal to 27 on the Free and Cued Selective Reminding Test (FCSRT) for prodromal AD.
- Subjects must have a positive florbetapir PET amyloid scan.
- Subjects must consent to APOE genotyping.
Patient Exclusion Criteria:
- Any medical or neurological condition (other than AD) that might be a contributing cause of the subject's cognitive impairment.
- Have had a stroke or TIA or unexplained loss of consciousness in the past 1 year.
- Clinically significant psychatric illness in past 6 months.
- Seizure in the past 3 years.
- Have human immunodeficiency virus (HIV) infection.
- Have a significant systematic illness or infection in past 30 days.
- Brain MRI showing evidence of greater than 4 microhemorrhages.
- Alcohol or substance abuse in past 1 year.
- Taking blood thinners (except for aspirin up to 325mg daily)
- Have changes in medications or doses of medication in past 4 weeks.
Details
| Clinical Study Identifier | TX136830 |
|---|---|
| Last Modified on | 25 March 2021 |
Eligibility
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