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Phase 4 N=50 Randomized Quadruple-blind Treatment

Study of Memantine to Treat Huntington's Disease

Huntington's Disease

Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Change in the Hopkins Verbal Learning Test - Revised for Delayed Recall (HVLT-R-delayed Recall)

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Memantine (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Jody Corey-Bloom, MD, PhD
Primary completion
Oct 2009

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in the Hopkins Verbal Learning Test - Revised for Delayed Recall (HVLT-R-delayed Recall)
SECONDARY
Neuropsychiatric Inventory (NPI)

Summary

To determine if memantine in doses of 10 mg BID affects memory, cognition, and behavior in patients with Huntington's disease (HD).

Eligibility Criteria

Inclusion Criteria

  • Men or women aged 18 or older.
  • Diagnosis of HD with current complaints of memory or concentration difficulties.
  • Dementia Rating Scale score of <129, to ensure that patients have sufficient cognitive impairment.
  • Adequate visual and auditory acuity to allow neuropsychological testing.
  • Good general health with no additional diseases expected to interfere with the study.
  • Patient is not institutionalized.
  • Sufficient English skills to complete all testing without assistance of an English language interpreter.
  • Availability of a responsible caregiver who agrees to supervise administration of study drug, monitor the patient's compliance and adverse events, and accompany the patient to all clinic visits.

Exclusion Criteria

  • 1. Any significant neurologic disease other than HD.
  • Severe psychotic features or other severe psychiatric problems within the last three months which could lead to difficulty complying with the protocol.
  • History of alcohol or substance abuse within the past two years (DSM IV criteria).
  • Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol.
  • History of MI in the past year or head trauma with loss of consciousness greater than 20 minutes.
  • Insulin-requiring diabetes.
  • Use of any FDA approved cognitive enhancing prescription medications or investigational drugs within 30 days.
  • Use of ginkgo biloba or DHEA within four weeks prior to baseline.
  • Use of narcotic analgesics within 4 weeks prior to baseline.
  • Patients who, in the investigator's opinion, would not comply with study procedures.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00652457). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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