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