|NIH Announces Phase III Clinical Trial of Creatine
for Parkinson's Disease
Nutritional Supplement May Slow Progression of
The NIH National Institute of Neurological Disorders and Stroke
(NINDS) today is launching a large-scale clinical trial to learn
if the nutritional supplement creatine can slow the progression
of Parkinson's disease (PD). While creatine is not an approved
therapy for PD or any other condition, it is widely thought to
improve exercise performance. The potential benefit of creatine
for PD was identified by Parkinsonís researchers through a new
rapid method for screening potential compounds.
The double-blind, placebo-controlled, phase III study is one of
the largest PD clinical trials to date. It will enroll 1720 people
with early-stage PD at 52 medical centers in the United States
"This study is an important step toward developing a therapy that
could change the course of this devastating disease," says Elias
A. Zerhouni, M.D., director of the NIH. "The goal is to improve
the quality of life for people with Parkinson's for a longer period
of time than is possible with existing therapies." Currently there
is no treatment that has been shown to slow the progression of
The trial is the first large study in a series of NINDS-sponsored
clinical trials called NET-PD (NIH Exploratory Trials in Parkinson's
Disease). NINDS has organized this large network of sites to allow
researchers to work with PD patients over a long period of time,
with a goal of finding effective and lasting treatments. NET-PD
builds on a developmental research process — from laboratory
research to pilot studies in a select group of patients, to the
definitive phase III trial of effectiveness in people with Parkinsonís
"This study is an example of the Institute's commitment to Parkinson's
research," says NINDS director Story C. Landis, Ph.D. "We are trying
to explore every possible option for reducing the burden of this
Participants will be in the phase III study for five to seven
years. The effort will be led by Karl Kieburtz, M.D., M.P.H., of
the University of Rochester in New York, and Barbara C. Tilley,
Ph.D., of the Medical University of South Carolina in Charleston,
and the patients will be seen by movement disorders specialists
at the NET-PD sites across the United States and Canada.
PD is a degenerative disorder of the brain in which patients develop
symptoms such as progressive tremor, slowness of movements, and
stiffness of muscles. It affects at least one million people in
the United States. Although certain drugs, such as levodopa, can
reduce the symptoms of PD, there are no proven treatments that
can slow the progressive deterioration in function.
Creatine is marketed as a nutritional supplement. Studies have
suggested that it can improve the function of mitochondria, which
produce energy inside cells. It also may act as an antioxidant
that prevents damage from compounds that are harmful to cells in
the brain. In a mouse model of PD, creatine is able to prevent
loss of the cells that are typically affected.
"Creatine, or any compound that may slow the progression of PD,
could have very important long-term benefits for people who are
living with this disease," says John R. Marler, M.D., NINDS associate
director for clinical trials.
The study will enroll people who have been diagnosed with PD within
the past five years and who have been treated for two years or
less with levodopa or other drugs that increase the levels of dopamine
in the brain. Many of the symptoms of PD result from the loss of
dopamine, a neurotransmitter that helps to control movement. Half
of the participants will receive creatine and half will receive
a placebo. Neither the participants nor their doctors will know
which treatment they receive.
"We are studying a stage of the disease that usually hasn't been
included in clinical studies," notes Dr. Kieburtz. The study is
designed to include a broad range of people, with special efforts
to recruit a diverse population that is similar to the makeup of
the population with PD in the United States.
The investigators will measure disease progression using standard
rating scales that measure quality of life, ability to walk, cognitive
function, and the ability to carry out other activities of daily
Avicena Group, Inc. will provide the creatine and the placebo
for the study.
People interested in participating in this study can obtain more
information by calling 1-800-352-9424, emailing firstname.lastname@example.org,
or visiting http://www.parkinsontrial.org/.
The NINDS is a component of the NIH within the Department of Health
and Human Services and is the nationís primary supporter of biomedical
research on the brain and nervous system.
The National Institutes of Health (NIH) — The Nation's
Medical Research Agency — includes 27 Institutes and
Centers and is a component of the U.S. Department of Health and
Human Services. It is the primary federal agency for conducting
and supporting basic, clinical and translational medical research,
and it investigates the causes, treatments, and cures for both
common and rare diseases. For more information about NIH and
its programs, visit www.nih.gov.