A Trial of Memantine as Symptomatic Treatment for Early Huntington Disease
Condition: Huntington Disease
MeSH terms: Huntington Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Huntington disease is characterized by difficulties in movement and thinking. Psychological
      disturbances including irritability, aggression, loss of interest, depressed mood, obsessions
      and compulsions, also represent common symptoms of HD. These symptoms are distressing both
      for HD patients and their caregivers, contribute to the loss of ability to carry out
      activities of daily living, and present a major treatment challenge for physicians. The goal
      of this study is to determine the effect of memantine on movement, thinking and emotional
      difficulties in HD patients. Memantine is a medication originally approved for the treatment
      of aggression and agitation in patients with moderate-to-severe Alzheimer's disease (AD),
      which has also recently been shown to improve the behavioural and neuropathological symptoms
      in a mouse model of Huntington Disease (HD).
    

Detailed description: 
      TRACK-HD was a multi-centre, multi-national, prospective, observational study of pre-manifest
      and early Huntington's disease (HD) with a control group of volunteers not carrying the HD
      mutation. The goal of the project was to contribute essential methodology that will form the
      basis for clinical trials in pre-manifest and early HD. TRACK-HD complemented existing
      observational studies (e.g., Predict-HD, PHAROS, COHORT), sharing some features, but also
      having areas of unique emphasis.

      The UBC site recruited 90 subjects including 30 control subjects, 30 asymptomatic
      pre-manifest HD gene carriers and 30 subjects with early symptoms of HD (stage 1 or 2). All
      subjects were assessed using the TRACK-HD battery at baseline, 1 year, 2 years, and 3 years.
      Following the fourth visit (3 year assessment), the TRACK-HD study will be completed, and the
      30 subjects with early symptoms of HD will be invited to enroll in the MITIGATE-HD Study.

      The MITIGATE-HD study is a single center Phase IIb,out-patient,randomized, double-blind,
      placebo-controlled trial of memantine treatment in subjects with Huntington disease (HD). The
      study will evaluate Memantine 10 mg two times daily (BID) administered orally (PO) for six
      months (24 weeks) compared with matching placebo BID. Safety and tolerability will be
      assessed by recording of adverse events and by monitoring of vital signs, physical
      examinations, and suicidality risk scores.

      The TRACK-HD assessment battery will be administered to all subjects after six months of
      study drug administration. The effects of memantine will be evaluated both against placebo as
      well as compared to the previous 3 years of observational data from the TRACK-HD Study.
    

Intervention name(s): Memantine; Placebo
Intervention type(s): Drug; Other
Intervention description(s): oral tablet, 1 BID, 24 weeks; oral tablet, 1 BID, 24 weeks
Other intervention name(s): Ebixa; DIN 02260638; Namenda
Intervention MeSH terms: Memantine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: huntington; huntingtin; memantine; ebixa; namenda