Much evidence suggests that Alzheimer’s disease (AD) is caused by amyloid plaque deposits and tangles in the brain which lead to cognitive decline, memory loss and behavioral changes. Amyloid, one of the main components of plaques in AD, is known to bind to Receptors for Advanced Glycated Endproducts (or RAGE, for short) on the surface of cells (e.g. the brain’s nerve cells and microglial cells) and at the blood brain barrier. This binding may trigger inflammation and damage to nerve cells. However, by blocking Amyloid-RAGE binding, researchers have found that plaque formation was reduced in animal models.

An experimental drug was developed as a RAGE antagonist, a novel pathway for trying to treat AD. The drug has been tested in animals, in small Phase I safety studies in healthy volunteers, and in a preliminary short safety study in AD patients. It is now being investigated in this larger Phase II clinical study to determine its efficacy (e.g. if it will slow the progressive decline associated with Alzheimer’s disease).

Douglas Galasko, M.D., Professor of Neurology at the University of California San Diego is directing the study. The study is taking place at more than 40 sites nationwide and seeks 399 volunteers with mild to moderate Alzheimer’s disease aged 50 or older to further test this novel approach. The ADCS is coordinating the 21-month, double-blind, placebo-controlled clinical study.

Physicians and nurses will monitor the participants during regular study visits and measure the severity and progression of disease using standard tests of memory and cognition. Two-thirds of the participants will receive study drug; the remainder will receive a placebo (inactive drug). To ensure unbiased results, neither the researchers conducting the study nor the participants will know who is receiving the study drug and who is getting the placebo.

Eligibility Criteria:

• age 50 or older
• have mild to moderate Alzheimer’s disease
• have not suffered from serious/unstable disease within the past three months
• are not diabetic
• have a study partner (caregiver, family member, friend) who can attend each study visit
• are willing and able to participate in the 21-month study

Study Procedures:

• physical and neurological exams
• brain magnetic resonance imaging

Compensation:

• all study procedures provided at no cost
• remuneration for LP test provided
• sites may provide compensation for parking, transportation and meals

To learn how to participate in the study, contact NIA’s Alzheimer’s Disease Education and Referral (ADEAR) Center at 1-800-438-4380 or by email to adear@nia.nih.gov. To view a list of the research sites or for information on dementia and aging, go to

Clinical Study Research Sites participating in the RI Study

 

Site	City	Phone
Banner Alzheimer’s Institute	Phoenix	602-239-6980
Baylor College of Medicine	Houston	713-798-8093
Brigham and Women’s Hospital	Boston	617-732-8085
Cleveland Clinic Lou Ruvo Center for Brain Health	Las Vegas
Columbia University	New York	212-305-7661
Emory University	Atlanta	404-728-6541
Georgetown University	Washington D.C.	202-687-3355
Howard University	Washington D.C.	202-865-7895
Indiana University	Indianapolis	317-278-8307
Johns Hopkins University	Baltimore	410-550-9053
Mayo Clinic, Jacksonville	Jacksonville	904-953-7103
Medical University of South Carolina	Charleston	843-740-1592, ext 18
Meharry Neurology Clinic	Nashville	615-327-6884
Mount Sinai School of Medicine	New York	212-241-1514
New York University	New York	212-263-5708
Northwestern University	Chicago	312-908-9869
Oregon Health Sciences University	Portland	503-494-9399
Pacific Research Network	San Diego	619-294-4302
Rhode Island Hospital	Providence	401-444-7691
Rush University Medical Center	Chicago	312-563-4340
St. Mary’s Health Care	Grand Rapids	616-685-5435
Stanford University	Palo Alto	650-852-3287
Sun Health Research Institute	Sun City	623-875-6526
University of California, Davis	Sacramento	925-372-2464
University of California, Irvine	Irvine	949-824-8726
University of California, Irvine, Brain Imaging Center	Irvine	714-456-8517
University of California, Los Angeles	Los Angeles	310-794-6191
University of California, San Diego	San Diego	858-622-5800
University of California, San Francisco	San Francisco	415-476-0671
University Hospitals Case Medical Center	Cleveland	216-844-6351
University of Kentucky	Lexington	859-257-1412, ext 289
University of Michigan	Ann Arbor	734-647-7760
University of Pennsylvania	Philadelphia	215-349-5903
University of Pittsburgh	Pittsburgh	412-692-2719
University of Rochester	Rochester	585-760-6585
University of South Florida	Tampa	813-974-4355
University of Southern California	Los Angeles	323-442-7534
University of Texas, Southwestern Medical Center	Dallas	214-648-0255
University of Utah Center for Alzheimer’s Care, Imaging and Research	Salt Lake City	801-581-4944
University of Washington	Seattle	206-764-2339
University of Wisconsin	Madison	608-256-1901, ext 11514
Wien Center	Miami	305-674-2424
Yale University	New Haven	203-764-8100