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-convulsant 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.
ADCS Member Sites (Listed by State)
University of California, Davis
University of California, Irvine
University of California, Los Angeles
Los Angeles, CA
University of California, San Diego
La Jolla, CA
University of Southern California
Los Angeles, CA
Yale University School of Medicine
New Haven, CT
Mayo Clinic, Jacksonville
University of South Florida, Tampa
Rush-Presbyterian-St. Lukes Medical Center
University of Kentucky, Lexington
Memorial Veterans Hospital, Boston University
University of Michigan, Ann Arbor
Ann Arbor, MI
Mayo Clinic, Rochester
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.nia.nih.gov/Alzheimers/. 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 is attached to this press release.
To contact Dr. Thal, call Sue Pondrom, UCSD Health Sciences Communications, at (619)543-6163 or by e-mail at firstname.lastname@example.org.