HSG to Conduct a Phase 2 Study in Adults with Mild-to-Moderate Huntington Disease

HD Lighthouse Contributing Editor's Comment: Dimebon is a drug that has been used as an antihistamine in Russia for more than two decades. A few years ago, interest developed in the drug's potential to treat neurodegenerative disorders so Medivation, Inc. acquired the rights to the drug. Medivation contracted with the Huntington's Study Group to conduct the clinical trials and a phase II study is about to begin.

Dimebon has several promising mechanisms. It is an acetylcholinesterase inhibitor like other drugs that have been shown to be effective in Alzheimer’s disease. It also regulates glutamate which is also effective in AD, much like memantine. Those mechanisms may address cognitive and behavioral problems in Huntington’s Disease. Research in Russia also suggests that this drug may regulate calcium homeostasis, preventing pathological opening of the mitochondrial permeability transition pores. See: Medivation Receives FDA Permission to Begin Dimebon Huntington's Disease Trial.

The study is designed to see if Dimebon will help with symptoms although it is possible that it may be a treatment for the disease itself. As Lighthouse readers know, a clinical trial designed to show effectiveness in treating the disease is costly and time consuming. If the drug is shown to be effective in treating symptoms, patients can get it sooner while work continues to see if it is also neuroprotective.

Participating sites will be listed here: HSG Therapeutic Trials, but in the meantime, you can call your closest HSG site and ask if they are planning to be part of the study: Huntington Study Group Research Sites

Medivation's commentary is here: Medivation - Dimebon

-- Marsha L. Miller, Ph.D.
Posted to the HDL: 28 Jul 2007

July 26, 2007 FOR IMMEDIATE RELEASE

The Huntington Study Group (HSG) is conducting a clinical study “A Multi-Center, Phase 2, Randomized, Double-Blinded, Placebo-Controlled Study of Dimebon in Subjects With Huntington Disease” (DIMOND) with the research medication – Dimebon – in patients who have mild to moderate Huntington disease (HD). The HSG is a worldwide, not-for-profit group of physicians and other clinical researchers who are experienced in the care of Huntington disease patients and dedicated to clinical research of Huntington disease. The study is sponsored by Medivation, Inc. with headquarters in San Francisco, CA.

Huntington disease (HD) is an inherited neurodegenerative disease characterized by brain cell death that usually begins between the ages of 30 to 50, and includes motor, cognitive and behavioral signs and symptoms. While there are medications to help relieve some of the disease symptoms, there is no known treatment to slow the progression of HD, which affects about 30,000 people in North America.

Dimebon is an investigational medication that has been shown to inhibit brain cell death in models of HD and Alzheimer’s disease (AD). In a 12-month study of patients with Alzheimer’s disease, Dimebon was well-tolerated and significantly improved cognition and memory, behavior, activities of daily living and overall function when compared to placebo. The safety of Dimebon has also been evaluated in a one-week study in HD patients. The current study will assess the effects of Dimebon on cognition, memory, behavior, and motor function of HD patients, as well as the safety and tolerability of the drug when administered over a 3 month period.

There is no cost to participate in the study. Individuals with mild-to-moderate Huntington disease who are interested in participating in this study should visit the Huntington Study Group website at: www.huntington-study-group.org or call the toll free number at 1-(800) 487-7671.

For more information contact: Leslie Briner
(585) 273-4147
Leslie.Briner@CTCC.Rochester.Edu

Original Document: HSG Press Release PDF

Source: Huntington Study Group

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