|Preliminary Study Shows Creatine and Minocycline May Warrant
Further Study In Parkinsonís Disease
A National Institutes of Health-sponsored clinical trial with 200 Parkinson's
disease patients has shown that creatine and minocycline may warrant further
consideration for study in a large trial, according to Karl Kieburtz, M.D., M.P.H.,
University of Rochester, who spoke today at the World Parkinson Congress on behalf
of the trial investigators. Study investigators caution that while the news is
encouraging, the results do not demonstrate that these agents are effective in
Parkinson's disease. Before these interventions can be recommended as a treatment
they must be tested in a larger trial with hundreds of patients. Study findings
are available online and will be published in the March 14 issue of Neurology.*
Parkinson's disease is a degenerative disorder of the brain in which patients
may develop progressive tremor, slowness of movements, and stiffness of muscles.
It affects approximately 1 percent of Americans over the age of 65. Although
certain drugs, such as levodopa, can reduce the symptoms of Parkinson's, no treatment
has been shown to slow the progressive deterioration in function.
The National Institute of Neurological Disorders and Stroke (NINDS) of the National
Institutes of Health (NIH) has organized a nationwide multi-center effort called
NET-PD (Neuroprotection Exploratory Trials in Parkinson's Disease), a randomized,
double-blind futility trial, to study compounds that may slow the clinical decline
of Parkinson's disease. As the initial step in these efforts, creatine and the
antibiotic minocycline were identified as agents worthy of preliminary study.
Patients very early in the disease course who did not yet need medications typically
used to treat their Parkinson's symptoms were included in the study.
"We are encouraged not only by these preliminary results, but also by the level
of collaboration in the Parkinson's community. These findings represent the efforts
of pharmacologists, clinicians, statisticians, and clinical trial experts — including
NINDS staff — who have come together with academia, industry, patients,
and foundation groups to advance the development of innovative therapies for
Parkinson's. The exceptional speed of patient recruitment allowed us to finish
this study in record time," said Story Landis, Ph.D., NINDS director.
Patients were randomly assigned to receive minocycline, 200 mg per day; creatine,
10 grams per day; or placebo. The study participants were then followed for 12
months. Researchers examined the safety and tolerability of taking these medications
as well as the severity of Parkinson's. Although neither agent caused major side
effects, minocycline was not as well tolerated. Both creatine and minocycline
appeared to modify the disease features as measured by a decline in the clinical
signs of Parkinson's disease. However, it is important to note that the study
was not designed nor intended to determine whether creatine or minocycline was
effective as a treatment for Parkinson's. The study was primarily designed to
determine whether it would be worthwhile to invest the resources necessary to
determine if creatine and minocycline are effective treatments. Studies to determine
the effectiveness of a drug typically require hundreds of patients followed for
Based on the initial analyses of the pilot studies, creatine and minocycline
have passed the first hurdle. Additionally, the NINDS has supported a pilot study
of two other compounds, Coenzyme Q10 and GPI-1485, and the investigators are
currently analyzing the data. The NINDS and the consortium are already planning
a large long-term study of neuroprotection in Parkinson's disease.
The trial investigators note that while encouraging, this pilot study does not
have sufficient numbers of patients or duration of follow-up to recommend that
patients with Parkinson's take either agent. In fact, the investigators caution
Parkinson's patients and their physicians not to interpret the results of this
study as suggesting such a course of treatment. Further study is required before
the researchers can conclude whether creatine or minocycline is in fact helpful,
harmful or has no significant impact.
The NINDS is a component of the National Institutes of Health (NIH) in Bethesda,
Maryland, and is the nation's primary supporter of biomedical research on the
brain and nervous system. For more information, visit the NINDS website at http://www.ninds.nih.gov or
the NET-PD website, http://www.parkinsontrial.org.
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 http://www.nih.gov.