Supplement Tested to Treat Neurological Disorders
Rochester Receives $13 Million to Coordinate Nationwide Efforts
Wednesday, December 07, 2005
Michael McDermott, Ph.D., associate professor, Biostatistics and Neurology
University of Rochester Medical Center scientists will coordinate two clinical trials involving 1,200 patients to verify whether a high dose of a popular nutritional supplement, coenzyme Q10, stalls the disabling symptoms of early Parkinson’s Disease and Huntington’s Disease.
The university was awarded $13 million for the Phase III studies from the National Institute of Neurological Disorders and Stroke. The trials were designed as follow-ups to previous studies, which showed that CoQ10 at lower doses appeared to slow the progression of the illnesses. But physicians believe that more evidence is needed before they can recommend CoQ10 as a treatment. The new Huntington’s trial will test the safety and benefit of CoQ10 at a higher dosage; the second trial for Parkinson’s disease patients will also attempt to confirm promising results from an earlier study of CoQ10, again by using a higher dosage.
“These studies are important next steps in our efforts to find treatments that improve the course of neurodegenerative diseases,” said Karl Kieburtz, M.D., M.P.H., professor of Neurology and Community and Preventive Medicine, and Unit Chief, Movement and Inherited Neurological Disorders Unit. “Currently no such treatments exist for Parkinson’s or Huntington’s.”
Huntington’s and Parkinson’s diseases are both progressive neurological disorders that result in the death of vital brain cells. Patients experience a gradual decline in the ability to function mentally and physically.
Improving the energy production of cells is one treatment strategy for the diseases. CoQ10, which is found naturally in nearly all of the cells in our body, has an important role in keeping healthy the mitochondria, a cell’s energy storehouse. CoQ10 is also an anti-oxidant, and it has been well tolerated by patients in other studies at both lower doses (600 mg/day) for long-term clinical trials, and at higher doses (2400 mg/day) for short-term clinical trials.
Doctors in the latest studies will be measuring whether CoQ10 helps patients retain the ability to move, to focus, and to perform chores. Individuals with Parkinson’s disease will receive either 1200 mg/day of CoQ10, or 2400 mg/day of CoQ10, or a matching placebo chewable wafer, and their conditions will be assessed for 16 months. Individuals with Huntington’s disease will receive either 2400 mg/day of CoQ10 or a matching placebo wafer. Those patients will be followed for five years.
The University of Rochester Medical Center Department of Biostatistics and Computational Biology, along with the Clinical Trials Coordination Center of the Department of Neurology, is coordinating both trials and managing and analyzing the data. The principal investigator for the Coordination and Statistical Center for the Parkinson’s trial is David Oakes, Ph.D., professor of Biostatistics at the University of Rochester; the principal investigator for the Coordination and Statistical Center for the Huntington’s trial is Michael McDermott, Ph.D., associate professor of Biostatistics and Neurology at the University of Rochester.
Collaborators on the project include M. Flint Beal, M.D., Weill Medical College, Cornell University, principal investigator for the Parkinson’s disease trial; and Merit Cudkowicz, M.D., Massachusetts General Hospital, principal investigator for the Huntington’s disease trial. Although funding has been secured, the clinical trials are not expected to begin until 2006.