HORIZON
(Placebo controlled Dimebon)
The purpose of Dimebon is to assess the safety and efficacy of Dimebon 60 mg per day, when taken over a period of 6 months. Efficacy is determined by exploring whether or not there is an effect on cognitive (thinking) abilities and overall functioning in people with HD. The study will also evaluate other HD symptoms including behavioral and motor (movement) symptoms.
The study is placebo controlled, meaning 50% of patients will receive the study drug, and 50% of the patients will receive placebo, or an inactive pill that looks and tastes like the study drug. The researcher will not know who receives the drug and who receives the placebo. The length of the study is 6 months with yet to be determined Open Label Arm of study.
Research subjects who successfully complete the first 6 months will have the option to be a part of an Open Label extension of the study. This means subjects will be on the Dimebon medication until the drug is FDA approved or the sponsor determines the drug was not effective.
The study will recruit:
- Men/Women age 30 yrs and up
- Participants must be psychiatrically stable
Participants may require more than minor assistance (no skilled nursing), have cognitive impairment, and must be ambulatory without assistance (UHDRS TFC score of 5 or greater)
- If the participant is taking Tetrabenazine, he or she must be on stable dose for 6 weeks prior to entering study
- Participants must be on stable doses of all other meds 4 weeks prior to entering study
- Klonopin/Wellbutrin/Antihistamines/Narcotic Analgesics are exclusionary medications
- A caregiver is required. The caregiver must be someone who assists or spends time with the study participant at least 5 days a week, 3 hours a day. The caregiver is required to attend all study visits with the study participant and must be willing to provide information about the study subject’s abilities and daily activities.
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The requirements listed above are not comprehensive. Study subjects must meet all of the individual study protocol criteria and in the opinion of the site study doctor and the sponsor’s medical monitor have the ability to participate in and complete the study.
