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Spring 2009

Clinical Trials and Studies Update

NOW RECRUITING:

RAGE Inhibitor (RI) trial

This Phase II trial, conducted by the NIA-supported Alzheimer's Disease Cooperative Study (ADCS) at 44 sites in the United States, seeks 399 participants, age 50 and older, with mild to moderate AD, to test whether doses of an experimental drug, called a RAGE inhibitor (RI), can help treat memory loss.

Many proteins surround the amyloid plaques in AD patients. One of the proteins, Receptor for Advanced Glycation Endpoints, called RAGE for short, binds to amyloid and may promote inflammation and lead to nerve cell damage. Researchers found that by inhibiting the RAGE protein, they could reduce plaque formation in animal models. This experimental R1 drug targets a novel pathway for trying to treat AD. Some participants will be invited to volunteer for an important sub-study, which includes magnetic resonance imaging of the brain and collection of cerebrospinal fluid to look for changes in beta amyloid protein and other markers.

Home-based Assessment for Alzheimer's Disease Prevention (HBA) study

The HBA study, conducted by the NIA-supported ADCs at 26 sites in the United States, is recruiting 600 healthy volunteers age 75 or older to test the use of mail, telephone, and computer assessments the participant can do at home. Since mobility and health issues may keep some individuals from participating in clinical trials, this study hopes to show that by reducing the number and length of clinic visits, future AD prevention trials may be able to increase participation while reducing costs. Participation will last 4 years, primarily in the participants' own homes.

Dominantly Inherited Alzheimer's Disease Network (DIAN) study

This international study of an inherited form of early-onset AD is recruiting 300 adults who have a biological parent with a known genetic mutation for AD. Researchers at 11 study sites in the United States, England, and Australia will create a database of participants' neuroimages and blood and cerebrospinal fluid samples to study predictors of the disease, for which participants are at high risk. Participants will also become part of a registry of younger adults with this rare autosomal-dominant form of AD. For more information, visit www.dian-info.org.

Gammaglobulin Alzheimer's Partnership (GAP) trial

The ADCS and Baxter Pharmaceuticals are recruiting 360 volunteers ages 50 to 89 with mild to moderate AD to study the effectiveness of intravenous immunoglobulin (IGIV) in reducing beta-amyloid in the brain. Participants at 39 sites will receive 18 months of treatment administered at home by nurses. IGIV is an established treatment for patients with certain immunodeficiencies.

For more information on these and other clinical trials and studies, visit the ADEAR Center's clinical trials database at www.nia.nih.gov/alzheimers/ResearchInformation/ClinicalTrials or the NIH database at www.clinicaltrials.gov.


 

 
 

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