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Receptor for Advanced Glycation Endproducts (RI Study)



Ongoing Studies Closed for Enrollment

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

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CLINICAL STUDY RESEARCH SITES PARTICIPATING IN THE RI STUDY

You can sort the Site name, City or Phone number by click one of the column titles.

SiteCityPhone
Banner Alzheimer's InstitutePhoenix602-239-6980
Baylor College of MedicineHouston713-798-8093
Brigham and Women's HospitalBoston617-732-8085
Cleveland Clinic Lou Ruvo Center for Brain HealthLas Vegas 
Columbia UniversityNew York212-305-7661
Emory UniversityAtlanta404-728-6541
Georgetown UniversityWashington D.C.202-687-3355
Howard UniversityWashington D.C.202-865-7895
Indiana UniversityIndianapolis317-278-8307
Johns Hopkins UniversityBaltimore410-550-9053
Mayo Clinic, JacksonvilleJacksonville904-953-7103
Medical University of South CarolinaCharleston843-740-1592, ext 18
Meharry Neurology ClinicNashville615-327-6884
Mount Sinai School of MedicineNew York212-241-1514
New York UniversityNew York212-263-5708
Northwestern UniversityChicago312-908-9869
Oregon Health Sciences UniversityPortland503-494-9399
Pacific Research NetworkSan Diego619-294-4302
Rhode Island HospitalProvidence401-444-7691
Rush University Medical CenterChicago312-563-4340
St. Mary’s Health CareGrand Rapids616-685-5435
Stanford UniversityPalo Alto650-852-3287
Sun Health Research InstituteSun City623-875-6526
University of California, DavisSacramento925-372-2464
University of California, IrvineIrvine949-824-8726
University of California, Irvine, Brain Imaging CenterIrvine714-456-8517
University of California, Los AngelesLos Angeles310-794-6191
University of California, San DiegoSan Diego858-622-5800
University of California, San FranciscoSan Francisco415-476-0671
University Hospitals Case Medical CenterCleveland216-844-6351
University of KentuckyLexington859-257-1412, ext 289
University of MichiganAnn Arbor734-647-7760
University of PennsylvaniaPhiladelphia215-349-5903
University of PittsburghPittsburgh412-692-2719
University of RochesterRochester585-760-6585
University of South FloridaTampa813-974-4355
University of Southern CaliforniaLos Angeles323-442-7534
University of Texas, Southwestern Medical CenterDallas214-648-0255
University of Utah Center for Alzheimer's Care, Imaging and ResearchSalt Lake City801-581-4944
University of WashingtonSeattle206-764-2339
University of WisconsinMadison608-256-1901, ext 11514
Wien CenterMiami305-674-2424
Yale UniversityNew Haven203-764-8100