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Energy supplement under study for Parkinson's
disease...Whether a supplement used by athletes
to boost energy levels and build muscle can slow
progression of Parkinson’s disease is the focus
of a North American study.
Creatine,
under study for a number of neurological and neuromuscular diseases
such as Lou Gehrig’s and muscular dystrophy, 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.
“We think
it may help cells that are damaged or overworked,” says Dr. Sethi, a
site principal investigator on the National Institute of
Neurological Disorders and Stroke study. MCG hopes to recruit 45
patients for the study that will enroll 1,720 patients at 51 sites
in the United States and Canada.
Mitochondria, the powerhouse for cells, become dysfunctional in the
brain, muscle and platelet cells of many patients with Parkinson’s
disease, Dr. Sethi says. Powerhouse dysfunction is discernible in
postmortem brain studies and in muscle biopsies and measures of
platelet activity in the living.
“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.”
The goal
is to slow progression of a disease that affects about 1 million
people in North America. 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
creatine study will enroll patients who have been on standard
therapies from 90 days to two years and follow them for five years.
Half the enrollees will get creatine and half placebo. The hope is
for at least a 20 percent reduction in disease progression, so that
at the end of five years, patients on creatine will look like
placebo patients at four years, says Buff Dill, MCG study
coordinator.
A number
of methods will be used to periodically measure disease progression,
including the Unified Parkinson’s Disease Rating Scale.
Following
disease progression over many years and measuring endpoints such as
falling, nursing home placement, dementia and death is the only way
to effectively assess treatment for a disease that typically
progresses slowly, Dr. Sethi says. In fact, the study may be
extended five more years, based on preliminary results and funding,
he says.
Those who
get creatine may have the added benefit of increased muscle, as is
true of athletes, Dr. Sethi says, noting that many patients
experience muscle atrophy and weight loss.
Although
creatine is available over the counter, he believes Parkinson’s
patients will still be interested in the study. “Patients realize
that we don’t know if it works. They are willing to take the risk of
being on placebo for the cause of science and to learn more about
the disease,” he says, noting the altruistic nature of many of his
patients. “They want to beat this disease and if they can’t, they
want to help somebody else beat it.”
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.
MCG will
participate in a similar study of coenzyme Q10, another natural
supplement that boosts energy production, later this year. Dr. Sethi,
project director of the Parkinson Research Alliance of India, which
is working to bring more clinical trials to his homeland, plans to
incorporate these supplements into innovative treatment cocktails
that will be studied there.
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