Phase 4
N=50
Study of Memantine to Treat Huntington's Disease
Huntington's Disease
Bottom Line
View on ClinicalTrials.gov: NCT00652457 ↗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
| Outcome | Result | p-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.
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.