A Phase 2 interventional study of Memantine and Placebo in Huntington Disease, sponsored by University of British Columbia. Completed at 1 site in Canada. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-01-13.
Sponsored by University of British Columbia · Phase 2, Interventional, and Treatment
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).
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.
285 studies on the registry are indexed under Huntington Disease; 49 are open to participants now.
This study's enrollment of 19 is below the median of 40 across 203 interventional studies indexed under Huntington Disease.
Browse Huntington Disease studies →University of British Columbia is the lead sponsor of 1,309 studies on the registry; 253 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
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To be eligible for the study, a subject must be enrolled in the early HD cohort of the TRACK-HD study and:
Exclusion Criteria:
Prospective subjects will be excluded if:
NMDA Receptor Antagonist
Drug: Memantine
Other: Placebo
oral tablet, 1 BID, 24 weeks
Also known as: Ebixa, DIN 02260638, Namenda
oral tablet, 1 BID, 24 weeks
Utility of TRACK-HD study endpoints in a clinical trial setting
To examine the clinical utility of novel trial endpoints (such as Putaminal NAA measured by MRS) developed in the TRACK-HD study in the setting of a placebo-controlled therapeutic trial.
Time frame: 24 weeks
Neuropsychiatric and Cognitive Test Scores
To examine effect of memantine versus placebo on the scores of: a) the irritability and agitation/aggression sub-categories of the Neuropsychiatric Inventory (NPI), and also the total NPI, b) cognitive tests: Circle Tracing , Symbol Digit Modality, Stroop Word Reading, and Spot the Change, c) total HD-ADL, d) total UHDRS, and the UHDRS sub-scale: Cognitive, Behavioural, Functional, and Independence scales. e) In patients recruited at the UBC study site, the effect on striatal N-acetyl aspartate levels (a measure of neuronal dysfunction) will be assessed by Magnetic Resonance Spectroscopy.
Time frame: 24 weeks
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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University of British Columbia