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.
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 Center's Clinical Trials Database.
A list
of the 31 primary ADCS sites follows.
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
