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BIIB037 in Prodromal or Mild Alzheimer's Disease

Active, not recruiting

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).

Minimum Age Maximum Age Gender Healthy Volunteers
50 Years 90 Years Both No
July 2012
June 2017
194

++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

++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

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.

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.

Name City State Zip Status Primary Contact
NNS Clinical Research, LLC
Tucson Arizona 85704

Senior Clinical Trials, Inc.
Laguna Hills California 92653

Torrance Clinical Research Institute, Inc.
Lomita California 90717

Collaborative Neuroscience Network, LLC
Long Beach California 90806

University of California, Los Angeles
Los Angeles California 90095

Pacific Neuroscience Medical Group
Oxnard California 93030

Pacific Research Network, Inc.
San Diego California 92103

San Francisco Clinical Research Center
San Francisco California 94109

Stanford University Medical Center
Stanford California 94304

Alzheimer's Disease Research Unit, Yale University
New Haven Connecticut 06520

Georgetown University Hospital
Washington District of Columbia 20057

Brain Matters Research, Inc.
Delray Beach Florida 33445

Neuropsychiatric Research Center of Southwest Florida
Fort Myers Florida 33912

MD Clinical Trials, Inc.
Hallandale Beach Florida 33009

Miami Jewish Health Systems
Miami Florida 33137

Galiz Research, LLC
Miami Springs Florida 33166

Compass Research, LLC
Orlando Florida 32806

Infinity Clinical Research, Inc.
Sunrise Florida 33351

Axiom Clinical Research of Florida
Tampa Florida 33609

Stedman Clinical Trials, LLC
Tampa Florida 33613

Neurostudies.net, LLC
Decatur Georgia 30033

Alexian Brothers Neurosciences Institute
Elk Grove Village Illinois 60007

Indiana University School of Medicine
Indianapolis Indiana 46202

St. Louis Clinical Trials, LLC
Saint Louis Missouri 63118

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

CRI Lifetree
Marlton New Jersey 08053

Advanced Memory Research Institute of NJ
Toms River New Jersey 08755

Empire Neurology, PC
Latham New York 12110

Insight Clinical Trials LLC
Beachwood Ohio 44122

Summit Research Network (Oregon) Inc.
Portland Oregon 97210

Brown Hospital
East Providence Rhode Island 02906

Rhode Island Hospital
Providence Rhode Island 02903

Biogen Idec

Name Phone Email
Medical Director 221AD103@biogenidec.com

NCT01677572

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