Vidyya Medical News Service

Volume 3 Issue 169 Published - 14:00 UTC 08:00 EST 22-Sep-2001 Next Update - 14:00 UTC 08:00 EST 23-Sep-2001	Editor: Susan K. Boyer, RN © RAmEx Ars Medica, Inc. All rights reserved.

	Alzheimer’s Disease Clinical Trials Expanded, Expedited As part of intensifying efforts to expand and expedite the search for Alzheimer’s disease (AD) treatments, the National Institute on Aging (NIA) has awarded $54 million to support the Alzheimer’s Disease Cooperative Study (ADCS), a national consortium of medical research centers and clinics. The network of 83 sites in the U.S. and Canada, coordinated by the University of California, San Diego (UCSD), will develop improved diagnostic tools and test a variety of drugs to slow down the progression of AD or prevent the disease altogether. The consortium was first organized in 1991 under a cooperative agreement between NIA, part of the National Institutes of Health, and UCSD. During its first decade, the ADCS put in place an infrastructure of leading researchers to carry out clinical trials for promising new therapies for AD, developed new and more reliable ways to evaluate patients enrolled in these and other studies, and initiated a number of clinical trials. This next 5-year award will allow that work to continue and will move AD treatment research in new directions, including the study of a cholesterol-lowering statin drug, an antioxidant, and a high-dose vitamin regimen. The ADCS will also develop evaluation tools for AD prevention research. “Basic and epidemiological studies over just the past few years have given us important clues about compounds that might prove more effective against AD,” says Neil Buckholtz, Ph.D., chief of the Dementias of Aging Branch at the NIA and project officer for the ADCS. “This award will help us test out a number of these possibilities quickly and reliably so that we can give clinicians, patients, and families new weapons in the fight against Alzheimer’s disease.” A degenerative disorder of the brain, AD is a devastating disease that robs its victims of memory and causes cognitive failure, leading to total dependence and, ultimately, death. It is estimated that as many as 4 million Americans suffer from AD. Leon Thal, M.D., chair of the Department of Neurosciences at the UCSD School of Medicine and principal investigator of the ADCS, notes that some 2,500 people have participated in 13 ADCS research studies over the past decade. Their contribution, he says, has greatly informed medical practice, as ADCS findings over the past few years have suggested what may – and what may not – work against the disease. Previous ADCS studies have looked at the use of vitamin E, the anti-Parkinson’s disease drug selegiline, and estrogen, among other drugs. Several studies are continuing or are being initiated in the 5-year effort. These include: Vitamin E and donepezil – This ongoing prevention trial, begun in 1999, examines whether vitamin E, an antioxidant, or donepezil, an agent that slows the breakdown of the neurotransmitter acetylcholine, may keep patients with Mild Cognitive Impairment from “converting” to AD. Some 700 patients are participating. Statins – This new study will test evidence from population and animal research that cholesterol might play a role in AD development. Patients with mild or moderate AD taking a cholesterol-lowering statin drug will be compared with AD patients of similar age and stage after 1 year to see if the use of the drug slowed down the progression of clinical signs of AD. High-dose folate/B6/B12 supplements – Research has shown that blood levels of homocysteine may be elevated in AD patients. This study is an 18-month clinical trial designed to test whether reducing homocysteine levels with the high-dose vitamin supplements can slow the rate of cognitive decline in people with AD. Valproate – Psychiatric symptoms associated with AD include agitation and psychosis, especially in later stages of the disease. In this 2-year trial, scientists will study whether low-dose valproate, an anti-psychotic drug, can help delay the emergence of agitation and psychosis. They will look at whether valproate may delay clinical progression of AD as well, in light of new studies suggesting that the drug may also be neuroprotective. Indole-3-Propionic Acid (IPA) – IPA, a highly potent, naturally occurring anti-oxidant, has been shown to interfere with the action of enzymes contributing to amyloid plaque formation, a hallmark of AD. This preliminary study will look at the safety and tolerability of IPA in patients with AD. Improved Assessment Measures – ADCS researchers will continue their work developing new or improved measures for evaluating the clinical effectiveness of drugs being tested for prevention or treatment of AD. The NIA leads the Federal effort to support and conduct basic, clinical, and social and behavioral studies on AD. It also supports the Alzheimer’s Disease Education and Referral (ADEAR) Center, which provides information on clinical trials and other research to the public, health professionals, and media. ADEAR can be contacted toll free at 1-800-438-4380 weekdays during business hours or by viewing www.alzheimers.org. As these clinical trials move forward and begin recruiting patients, the public will be able to find out more about participation through the ADEAR website. A list of the 31 primary ADCS sites appears below: ADCS Member Sites (Listed by State) California Stanford University Stanford, CA (650) 852-3287 University of California, Davis Martinez, CA (925) 372-2485 University of California, Irvine Irvine, CA (949) 824-8726 University of California, Los Angeles Los Angeles, CA (310) 825-8908 University of California, San Diego La Jolla, CA (858) 622-5820 University of Southern California Los Angeles, CA (323) 442-3715 Connecticut Yale University School of Medicine New Haven, CT (203) 764-8100 Florida Mayo Clinic, Jacksonville Jacksonville, FL (904) 953-7103 University of South Florida, Tampa Tampa, FL (813) 974-4355 Georgia Emory University Atlanta, GA (404) 728-6453 Illinois Northwestern University Chicago, IL (312) 695-2343 Rush-Presbyterian-St. Lukes Medical Center Chicago, IL (312) 942-8264 Indiana Indiana University Indianapolis, IN (317) 278-3934 Kentucky University of Kentucky, Lexington Lexington, KY (859) 257-6508 Massachusetts Memorial Veterans Hospital, Boston University Bedford, MA (781) 687-2845 Michigan University of Michigan, Ann Arbor Ann Arbor, MI (734) 936-8764 Minnesota Mayo Clinic, Rochester Rochester, MN (507) 266-8485 Missouri Washington University St. Louis, MO (314) 286-2364 New York Columbia University New York, NY (212) 305-2371 Mt. Sinai School of Medicine New York, NY (212) 241-0438 University of Rochester Medical Center Rochester, NY (716) 760-6561 Ohio University Hospitals of Cleveland Cleveland, OH (216) 844-6419 Oregon Oregon Health Sciences University Portland, OR (503) 494-7615 Pennsylvania University of Pennsylvania Philadelphia, PA (215) 349-5903 University of Pittsburgh Pittsburgh, PA (412) 692-2705 Rhode Island Brown University Memorial Hospital of Rhode Island Pawtucket, RI (401) 729-3752 South Carolina Medical University of South Carolina North Charleston, SC (843) 740-1592 x17 Texas Baylor College of Medicine, Houston Houston, TX (713) 798-5325 University of Texas, Southwestern Medical Center Dallas, TX (214) 648-7466 Washington University of Washington Seattle, WA (206) 277-1493 Washington, DC Georgetown University Washington DC (202) 784-6671

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