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Alzheimer's, Parkinson's & Mental Health
Major Parkinson's Trial Begins Testing Energy
Booster's Ability to Slow the Disease
 Creatine to be tested in 52 sites with 1,720
participants
March 22, 2007 – A major effort kicked off today to
determine if a supplement used by athletes to boost energy levels and
build muscle – creatine - can slow the progression of Parkinson’s
disease. The NIH National Institute of Neurological Disorders and Stroke
(NINDS) is launching one of the largest PD clinical trials to date in 52
medical centers that will enroll 1,720 people with early stage PD.
While creatine is not an approved therapy for PD or
any other condition, it is widely thought to improve exercise
performance.
 It is already under study for a number of neurological and
neuromuscular diseases such as Lou Gehrig’s and muscular dystrophy and
may help Parkinson’s patients by giving an energy boost to dying cells,
says Dr. Kapil D. Sethi, neurologist and director of the Movement
Disorders Program at the Medical College of Georgia, one of the sites
for the double-blind, placebo-controlled, phase III study.
The potential benefit of creatine for PD was
identified by Parkinson’s researchers through a new rapid method for
screening potential compounds.
 "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."
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Currently there is no treatment that has been
shown to slow the progression of PD.
According to the Parkinson's Disease Foundation,
roughly 1.5 million Americans are affected by Parkinson's disease,
making it the second most common neurodegenerative disease after
Alzheimer's disease. Approximately 60,000 new cases are diagnosed each
year in the United States.
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Hallmarks include tremors, rigidity and slowed
movement. Late in the disease, the majority of patients also develop
dementia and behavior disorders.
Today’s therapies – including the gold standard, a
synthetic dopamine called levodopa and MAO-B inhibitors that forestall
breakdown of dopamine – are geared toward treating symptoms. Dopamine, a
neurotransmitter critical to movement, is depleted in Parkinson’s.
Researchers hope newer therapies, including creatine, can be added to
the mix to help slow the disease.
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 Parkinson’s disease.
"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 disease."
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.
About Creatine
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.
“We think it may help cells that are damaged or
overworked,” says Dr. Sethi.
“By giving more energy to the cell, you are giving
them a safety margin,” Dr. Sethi says. “If a cell is dying, it takes
another route and that would be surviving.”
"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.
Avicena Group, Inc., will provide creatine and
placebo for this first large study in a series of National Institutes of
Health-sponsored exploratory trials in Parkinson’s.Clinical Trials.
Avicena markets Neotine, a proprietary medical
grade creatine-based nutritional supplement, which is "designed to
promote neuronal cell health by producing and maintaining high levels of
the brain’s natural energy supply."
The company says, "There is extensive scientific
data to support the importance of creatine and the creatine kinase
system in the proper functioning of the brain."
Clinical Trial
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.
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 People
over age 60 have a two-to-four percent risk of developing
Parkinson's disease, compared with the one-to-two percent risk
in the general population.
Parkinson's Disease
Foundation |
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 living.
People interested in participating in this study
can obtain more information by calling 1-800-352-9424, emailing
info@parkinsontrial.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 nation’s 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.
>>
Avencia Group and Creatine
>>
Creatine - Wikipedia, the free
encyclopedia
>>
Creatine Supplementation in Athletes:
Review
>>
Creatine Journal
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