Apathy in Dementia Methylphenidate Trial (ADMET)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Apathy Evaluation Scale (AES)
研究概览
简要总结
The Apathy in Dementia Methylphenidate Trial (ADMET) is a masked, placebo-controlled trial that will examine the efficacy and safety of methylphenidate for the treatment of clinically significant apathy in patients with Alzheimer's dementia.
详细描述
The Apathy in Dementia Methylphenidate Trial (ADMET), funded by the National Institute of Aging, is a Phase II, placebo-controlled, masked, 3-center randomized clinical trial. ADMET will enroll 60 patients with Alzheimer's disease (AD) and significant apathy from outpatient, nursing home, and assisted living facilities along with their primary caregiver. Eligible and willing patients will be randomly assigned to methylphenidate (20 mg per day) or placebo. At baseline and each in-person follow-up visit, all caregivers and patients will be provided with a standardized psychosocial intervention consisting of a counseling session, provision of educational materials, and 24-hour availability for crises. Efficacy and safety outcomes will be measured at baseline and at in-person follow-up visits at 2, 4, and 6 weeks following randomization. Telephone contact will take place at 1, 3, and 5 weeks after randomization.
ADMET has 80% power to detect a difference of at least 3.3 in change in the Apathy Evaluation Scale scores between the two treatment groups. It also has 80% power to detect an absolute difference of 35% or more in the change in the proportion of study participants improving on te Clinical Global Impression of Change, given that 20% to 305 of participants in the placebo group show improvement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Methylphenidate
Methylphenidate, target dose 20 mg per day (range 10-20 mg per day) and psychosocial intervention
干预措施: Methylphenidate (Drug)
Methylphenidate
Methylphenidate, target dose 20 mg per day (range 10-20 mg per day) and psychosocial intervention
干预措施: Psychosocial intervention (Other)
Placebo
matching placebo and psychosocial intervention
干预措施: placebo (Drug)
Placebo
matching placebo and psychosocial intervention
干预措施: Psychosocial intervention (Other)
结局指标
主要结局
Apathy Evaluation Scale (AES)
时间窗: baseline to 6 weeks
Change in score of Apathy Evaluation Scale from baseline to 6 weeks; the minimum score is 18; the maximum score is 72. Higher scores indicate more severe apathy.
Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change
时间窗: baseline to 6 weeks
Proportion of individuals improving on Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (CGIC) from baseline to 6 weeks; the CGIC is a 7-point Likert scale used to rate each patient with the following scores: "marked worsening"(7), "moderate worsening" (6), "minimal worsening"(5), "no change"(4), "minimal improvement"(3), "moderate improvement"(2), "marked improvement"(1). Ratings were based on an interview with the caregiver and an examination of the patient. The CGIC requires the clinician to consider a number of aspects of apathy, such as level of initiative, level of interest, and emotional engagement.
次要结局
- Digit Span(baseline and 6 weeks)
- Mini-Mental State Exam (MMSE)(baseline and 6 weeks)
- Neuropsychiatric Inventory (NPI): Apathy Subscale(baseline to week 6)
- Vital Status(vital status at 6 weeks)
- Electrolytes(6 weeks)
- Electrocardiogram (ECG)(6 weeks)