Alzheimer's Disease Education and Referral Center

BIIB037 in Prodromal or Mild Alzheimer's Disease

Overall Status: 
Active, not recruiting
Brief Description: 

The primary 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. The secondary purpose is to assess the drug's effect on cerebral amyloid plaque, as measured by positron emission tomography (PET).

Patient Qualifications: 
Min AgeMax AgeGenderHealthy Volunteers
50 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. In addition, participants will undergo PET imaging to assess the serum concentrations of BIIB037 and to evaluate the immunogenicity of BIIB037 after multiple doses.

Participants will receive 14 doses of BIIB037, 4 weeks apart, over 1 year. Afterward, they will have the option of enrolling in a 1-year, long-term extension study to receive 14 more doses of the drug.

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 CityStateZip CodeStatusPrimary Contact

Geolocation is 33.590277, -117.6962824

Site
Laguna Hills
California
92653
Name:
Phone:

Geolocation is 33.7922392, -118.3150722

Site
Lomita
California
90717
Name:
Phone:

Geolocation is 33.8065036, -118.1912538

Site
Long Beach
California
90806
Name:
Phone:

Geolocation is 34.070264, -118.4440562

Site
Los Angeles
California
90095
Name:
Phone:

Geolocation is 34.2054029, -119.1681373

Site
Oxnard
California
93030
Name:
Phone:

Geolocation is 33.1, -117.28

Site
San Diego
California
92013
Name:
Phone:

Geolocation is 37.7929789, -122.4212424

Site
San Francisco
California
94109
Name:
Phone:

Geolocation is 37.424106, -122.1660756

Site
Standford
California
94305
Name:
Phone:

Geolocation is 41.28905, -72.9022251

Site
New Haven
Connecticut
6519
Name:
Phone:

Geolocation is 41.28905, -72.9022251

Site
New Haven
Connecticut
6510
Name:
Phone:

Geolocation is 38.9079086, -77.0716829

Site
Washington
District of Columbia
20057
Name:
Phone:

Geolocation is 26.3767589, -80.1037721

Site
Boca Raton
Florida
33431
Name:
Phone:

Geolocation is 26.5273497, -81.8333656

Site
Fort Meyers
Florida
33912
Name:
Phone:

Geolocation is 25.9812024, -80.148379

Site
Hallandale Beach
Florida
33009
Name:
Phone:

Geolocation is 25.8223198, -80.289495

Site
Miami Springs
Florida
33166
Name:
Phone:

Geolocation is 25.8207159, -80.1819268

Site
Miami
Florida
33137
Name:
Phone:

Geolocation is 26.17785, -80.2711588

Site
Sunrise
Florida
33351
Name:
Phone:

Geolocation is 27.9407591, -82.5104655

Site
Tampa
Florida
33609
Name:
Phone:

Geolocation is 28.0869646, -82.4698603

Site
Tampa
Florida
33613
Name:
Phone:

Geolocation is 33.8092255, -84.2805478

Site
Decatur
Georgia
30033
Name:
Phone:

Geolocation is 42.0039178, -87.9703461

Site
Elk Grove Village
Illinois
60007
Name:
Phone:

Geolocation is 39.7794767, -86.1700894

Site
Indianapolis
Indiana
46202
Name:
Phone:

Geolocation is 40.320478, -74.089186

Site
Eatontown
New Jersey
7724
Name:
Phone:

Geolocation is 39.4614927, -74.8180657

Site
Merlton
New Jersey
8053
Name:
Phone:

Geolocation is 39.9650327, -74.2167817

Site
Tom's River
New Jersey
8755
Name:
Phone:

Geolocation is 42.7477661, -73.760537

Site
Latham
New York
12110
Name:
Phone:

Geolocation is 45.5478224, -122.7288206

Site
Portland
Oregon
97210
Name:
Phone:

Geolocation is 41.8285822, -71.4314216

Site
East Providence
Rhode Island
2906
Name:
Phone:

Geolocation is 41.8285822, -71.4314216

Site
Providence
Rhode Island
2903
Name:
Phone:
Lead Sponsor: 
Agency
Biogen Idec
Collaborator Sponsor: 
Facility Investigators: 
Study Contact: 
NameEmail
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: 
June 2017
Disease Stage: 
Early
Enrollment: 
194