Alzheimer's Disease Education and Referral Center

BIIB037 in Prodromal or Mild Alzheimer's Disease

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 CodePrimary Contact

Geolocation is 33.590277, -117.6962824

Senior Clinical Trials, Inc.
Laguna Hills
California
92653

Geolocation is 33.7922392, -118.3150722

Torrance Clinical Research Institute, Inc.
Lomita
California
90717

Geolocation is 33.8065036, -118.1912538

Collaborative Neuroscience Network, Inc.
Long Beach
California
90806

Geolocation is 34.070264, -118.4440562

University of California, Los Angeles
Los Angeles
California
90095

Geolocation is 34.2054029, -119.1681373

Pacific Neuroscience Medical Group
Oxnard
California
93030

Geolocation is 33.1, -117.28

Pacific Research Network, Inc.
San Diego
California
92013

Geolocation is 37.7929789, -122.4212424

San Francisco Clinical Research Center
San Francisco
California
94109

Geolocation is 37.424106, -122.1660756

Stanford University Medical Center
Standford
California
94305

Geolocation is 41.3052226, -72.9268626

Institute For Neurodegenerative Disorders
New Haven
Connecticut
06510

Geolocation is 41.2958246, -72.937198

Alzheimer's Disease Research Unit, Yale University
New Haven
Connecticut
06519

Geolocation is 38.9079086, -77.0716829

Georgetown University Hospital
Washington
District of Columbia
20057

Geolocation is 26.3767589, -80.1037721

Florida Atlantic University
Boca Raton
Florida
33431

Geolocation is 26.5273497, -81.8333656

Neuropsychiatric Research Center of Southwest Florida
Fort Meyers
Florida
33912

Geolocation is 25.9812024, -80.148379

MD Clinical
Hallandale Beach
Florida
33009

Geolocation is 25.8223198, -80.289495

Galiz Research, LLC
Miami Springs
Florida
33166

Geolocation is 25.8207159, -80.1819268

Miami Jewish Health Systems
Miami
Florida
33137

Geolocation is 26.17785, -80.2711588

Neurology Clinical Research, Inc.
Sunrise
Florida
33351

Geolocation is 27.9407591, -82.5104655

Axiom Clinical Research of Florida
Tampa
Florida
33609

Geolocation is 28.0869646, -82.4698603

Stedman Clinical Trials, LLC
Tampa
Florida
33613

Geolocation is 33.8092255, -84.2805478

Neurostudies.net, LLC
Decatur
Georgia
30033

Geolocation is 42.0039178, -87.9703461

Alexian Brothers Neurosciences Institute
Elk Grove Village
Illinois
60007

Geolocation is 39.7794767, -86.1700894

Indiana University School of Medicine
Indianapolis
Indiana
46202

Geolocation is 40.2962222, -74.0509725

Memory Enhancement Center of America, Inc.
Eatontown
New Jersey
07724

Geolocation is 39.8912248, -74.9218324

CRI Lifetree
Merlton
New Jersey
08053

Geolocation is 40.0207099, -74.2061931

Memory Enhancement Center of NJ
Tom's River
New Jersey
08755

Geolocation is 42.7477661, -73.760537

Empire Neurology, PC
Latham
New York
12110

Geolocation is 45.5478224, -122.7288206

Summit Research Network (Oregon) Inc.
Portland
Oregon
97210

Geolocation is 41.8396817, -71.3883751

Butler Hospital
East Providence
Rhode Island
02906

Geolocation is 41.816736, -71.4091563

Rhode Island Hospital
Providence
Rhode Island
02903
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