A Pilot Study of Memantine for Cognitive and Behavioral Dysfunction in Huntington's Disease"
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Change in the Hopkins Verbal Learning Test - Revised for Delayed Recall (HVLT-R-delayed Recall)
研究概览
简要总结
To determine if memantine in doses of 10 mg BID affects memory, cognition, and behavior in patients with Huntington's disease (HD).
详细描述
Results of several published clinical trials suggest that memantine has a beneficial effect in dementing conditions, such as Alzheimer's disease; however, the effects of memantine on cognitive and behavioral function in HD are unknown. Our hypotheses are that HD patients who are administered memantine will show improved performance on psychometric tests of memory and executive functions in addition to behavior and that patients treated with memantine will show more improvement after six months than after three months of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Memantine
Memantine 10 mg BID for three months
干预措施: Memantine (Drug)
Placebo
Placebo 10 mg BID for three months
干预措施: Memantine (Drug)
结局指标
主要结局
Change in the Hopkins Verbal Learning Test - Revised for Delayed Recall (HVLT-R-delayed Recall)
时间窗: Baseline, 3 months from start of drug treatment, 6 months from start of drug treatment
The HVLT-R consists of 3 parts. Free recall has a range of 0 to 36, delayed recall has a range from 0 to 12, and delayed recognition has a range of -12 to 12. Higher scores indicating better function in all 3 parts. Standardized scores are used by calculating an average standardized z score for each part of the HVLT-R. Change is calculated by subtracting baseline value from the respective later time point value. Imputation methods were used to determine values for all alive patients missing the post-baseline assessments. This tool is being used to measure cognitive function, specifically memory.
次要结局
- Neuropsychiatric Inventory (NPI)(Baseline, 3 months from start of drug treatment, 6 months from start of drug treatment)
研究者
Jody Corey-Bloom, MD, PhD
Professor
University of California, San Diego