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BIIB037 in Prodromal or Mild Alzheimer's Disease

Start: July 2012
End: July 31, 2019
Enrollment: 194

What Is This Study About?

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).

Do I Qualify To Participate in This Study?

Minimum Age: 50 Years

Maximum Age: 90 Years

Must have:

++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

Must NOT have:

++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

 

Who Is the General Study Contact?

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.

Study Contact
Medical Director

Need Help?

Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.

Where Is This Study Located?

Arizona
NNS Clinical Research, LLC
Tucson, AZ 85704
California
Senior Clinical Trials, Inc.
Laguna Hills, CA 92653
Torrance Clinical Research Institute, Inc.
Lomita, CA 90717
Collaborative Neuroscience Network, LLC
Long Beach, CA 90806
University of California, Los Angeles
Los Angeles, CA 90095
Pacific Neuroscience Medical Group
Oxnard, CA 93030
Pacific Research Network, Inc.
San Diego, CA 92103
San Francisco Clinical Research Center
San Francisco, CA 94109
Stanford University Medical Center
Stanford, CA 94304
Connecticut
Alzheimer's Disease Research Unit, Yale University
New Haven, CT 06520
District of Columbia
Georgetown University Hospital
Washington, DC 20057
Florida
Brain Matters Research, Inc.
Delray Beach, FL 33445
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, FL 33912
MD Clinical Trials, Inc.
Hallandale Beach, FL 33009
Miami Jewish Health Systems
Miami, FL 33137
Galiz Research, LLC
Miami Springs, FL 33166
Compass Research, LLC
Orlando, FL 32806
Infinity Clinical Research, Inc.
Sunrise, FL 33351
Axiom Clinical Research of Florida
Tampa, FL 33609
Stedman Clinical Trials, LLC
Tampa, FL 33613
Georgia
Neurostudies.net, LLC
Decatur, GA 30033
Illinois
Alexian Brothers Neurosciences Institute
Elk Grove Village, IL 60007
Indiana
Indiana University School of Medicine
Indianapolis, IN 46202
Missouri
St. Louis Clinical Trials, LLC
Saint Louis, MO 63118
New Jersey
Memory Enhancement Center of America, Inc.
Eatontown, NJ 07724
CRI Lifetree
Marlton, NJ 08053
Advanced Memory Research Institute of NJ
Toms River, NJ 08755
New York
Empire Neurology, PC
Latham, NY 12110
Ohio
Insight Clinical Trials LLC
Beachwood, OH 44122
Oregon
Summit Research Network (Oregon) Inc.
Portland, OR 97210
Rhode Island
Brown Hospital
East Providence, RI 02906
Rhode Island Hospital
Providence, RI 02903

Who Sponsors This Study?

Lead: Biogen Idec

Source: ClinicalTrials.gov ID: NCT01677572