The Huntington Study Group has launched a Phase III clinical trial to determine the effect of the maximum effective dosage of Coenzyme Q10 on cognitive function in people with Huntington’s Disease.

Kaneka Nutrients’ KanekaQ10, the only CoQ10 manufactured in the U.S., is the sole source of CoQ10 being used in the trial, which is funded by the National Institute of Neurological Disorders and Stroke—part of the National Institutes of Health (NIH).

The 5-year, double-blind, placebo-controlled study (called the 2CARE Study) will involve 608 patients in 44 centers across the U.S., Canada and Australia. It will be the largest therapeutic clinical trial to date focused on Huntington’s disease.

Researchers will examine the long-term safety of CoQ10, which occurs naturally in the body and is involved in cellular energy production and has documented heart and neurological benefits. Research has shown that aging, various medications, and certain diseases inhibit the body’s ability to produce CoQ10 on its own.

Currently, there is no known cure or effective drug therapy for Huntington’s Disease (HD), a genetic, progressive brain disorder that causes uncontrolled movements, cognitive difficulties and emotional disturbances. According to the Huntington’s Disease Society of America, more than a quarter of a million Americans have HD or are “at risk” of inheriting the disease from an affected parent.

The multi-million dollar grant from the NIH’s National Institute of Neurological Disorders and Stroke was awarded to Massachusetts General Hospital and The University of Rochester. Merit Cudkowicz, MD, MSc (Massachusetts General Hospital) and Michael McDermott PhD and Karl Kieburtz MD MPH (University of Rochester), will direct the study.

“Since there are no FDA-approved drugs currently on the market that slow the functional decline of those suffering from Huntington’s, this is an extremely important trial, and Kaneka Nutrients is proud to be involved,” said Dr. Robert Barry, Director of Scientific Affairs for Kaneka Nutrients L.P.’s U.S. Operations. “As the purest, most rigorously tested CoQ10 available, KanekaQ10 has been used in all major CoQ10 clinical trials approved by the FDA and funded by the NIH. We’re eager to see the trial results since they pose hope for a better quality of life for patients suffering from this debilitating disease.”