BIIB037 in Prodromal or Mild Alzheimer's Disease
BIIB037 in Prodromal or Mild Alzheimer's Disease
Overall Status:
Recruiting
Brief Description:
The purpose of this study is to evaluate the safety and tolerability of multiple doses of the experimental drug BIIB037, administered via intravenous infusions, in people with prodromal or mild Alzheimer's disease.
Patient Qualifications:
| Min Age | Max Age | Gender | Healthy Volunteers |
|---|---|---|---|
55 Years | 90 Years | Both | No |
Inclusion Criteria:
- Meet criteria for prodromal or mild Alzheimer's disease: Mini Mental State Examination (MMSE) score between 20-30; Clinical Dementia Rating Scale (CDR) score of 0.5 or 1; and free recall score of less than or equal to 27 on the Free and Cued Selective Reminding Test (FCSRT) for prodromal Alzheimer's disease
- Positive florbetapir PET amyloid scan
- Consent to APOE genotyping
Exclusion Criteria:
- Any medical or neurological condition (other than AD) that might be a contributing cause of the participant's cognitive impairment
- Stroke, transient ischemic attack, or unexplained loss of consciousness in the past year
- Clinically significant psychiatric illness in the past 6 months
- Seizure in the past 3 years
- Human immunodeficiency virus (HIV) infection
- Significant systematic illness or infection in the past 30 days
- Brain MRI showing evidence of greater than 4 microhemorrhages
- Alcohol or substance abuse in the past year
- Use of blood thinners (except for aspirin up to 325 mg daily)
- Changes in medications or doses of medication in the past 4 weeks
Detailed Description:
BIIB037 is a fully human immunoglobulin gamma 1 (IgG1) monoclonal antibody that is being developed as a disease modification treatment for Alzheimer's disease. In animal models of Alzheimer's, treatment with BIIB037 was shown to decrease beta-amyloid content in animal brains. A single ascending dose study of BIIB037 in people with mild to moderate Alzheimer's is ongoing. This study will be conducted in people with prodromal or mild Alzheimer's to assess the safety, tolerability, pharmacokinetic, and pharmacodynamic profile after multiple doses of BIIB037.
Central Contact Information:
Contact the trial sponsor's Medical Director at 221AD103@biogenidec.com for information about participating sites. NOTE: Zip codes given are for general location information only and may not be representative of the actual site.
Locations:
| Map Marker | City | State | Status | |
|---|---|---|---|---|
Geolocation is 32.2217429, -110.926479 | Site | Tucson | Arizona | Recruiting |
Geolocation is 37.7749295, -122.4194155 | Site | San Francisco | California | Recruiting |
Geolocation is 26.4614625, -80.0728201 | Site | Delray Beach | Florida | Recruiting |
Geolocation is 26.640628, -81.8723084 | Site | Fort Myers | Florida | Recruiting |
Geolocation is 25.9812024, -80.148379 | Site | Hallendale Beach | Florida | Recruiting |
Geolocation is 28.5383355, -81.3792365 | Site | Orlando | Florida | Recruiting |
Geolocation is 27.950575, -82.4571776 | Site | Tampa | Florida | Recruiting |
Geolocation is 38.6270025, -90.1994042 | Site | St. Louis | Missouri | Recruiting |
Geolocation is 40.2962222, -74.0509725 | Site | Eatontown | New Jersey | Recruiting |
Geolocation is 39.9537358, -74.1979458 | Site | Toms River | New Jersey | Recruiting |
Geolocation is 39.9489774, -82.8869418 | Site | Beechwood | Ohio | Recruiting |
Geolocation is 41.6639383, -83.555212 | Site | Toledo | Ohio | Recruiting |
Lead Sponsor:
| Agency |
|---|
Biogen Idec |
Collaborator Sponsor:
Facility Investigators:
Study Contact:
| Name | |
|---|---|
Medical Director |
Locations
ClinicalTrials.gov ID
NCT01677572 (follow link to view full record on ct.gov in new window)
Official Title:
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
Study Start Date:
July 2012
Study End Date:
April 2014
Disease Stage:
Early
Enrollment:
120
