Memantine and Comprehensive, Individualized, Patient Centered Management of Alzheimer's Disease: Health Outcome
Memantine and Comprehensive, Individualized, Patient Centered Management of Alzheimer's Disease: A Randomized Controlled Trial: Further Study, Health Outcome
This study is a retrospective review of the data collected in a previously completed randomized, controlled trial (RCT) entitled "Memantine and Comprehensive, Individualized, Patient Centered Management of Alzheimer's Disease: A Randomized Controlled Trial" (NCT00120874). As part of the previously completed RCT, participants with Alzheimer's Disease (AD) were randomly placed into one of two groups: memantine, or memantine plus an individualized management program consisting of home visits, educational sessions for caregivers, and a caregiver support group. Participants received the study intervention for 28 weeks; study follow-up lasted for 52 weeks.
The collected data from the existing study books from the 28 week treatment portion of the RCT will be carefully examined with respect to each of the research questions for the present retrospective study.
研究概览
地位
条件
研究类型
注册 (实际的)
联系人和位置
学习地点
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New York
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New York、New York、美国、10016
- New York University School of Medicine
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Previously participated in the "Memantine and Comprehensive, Individualized, Patient Centered Management of Alzheimer's Disease: A Randomized Controlled Trial" study.
学习计划
研究是如何设计的？
设计细节
- 观测模型：病例对照
- 时间观点：追溯
队列和干预
团体/队列 |
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Memantine Alone
10 subjects who previously participated in the "Memantine and Comprehensive, Individualized, Patient Centered Management of Alzheimer's Disease: A Randomized Controlled Trial" study will be enrolled in this cohort.
These subjects received memantine for a period of 28 weeks.
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Memantine plus Individualized Management of AD
10 subjects who previously participated in the "Memantine and Comprehensive, Individualized, Patient Centered Management of Alzheimer's Disease: A Randomized Controlled Trial" study will be enrolled in this cohort.
These subjects received memantine plus individualized management of AD for a period of 28 weeks.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
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Total number of prescription medications taken throughout the study
大体时间：28 weeks
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28 weeks
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Total number of hospitalizations
大体时间：28 weeks
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28 weeks
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The total number of new medical conditions
大体时间：28 weeks
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28 weeks
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Total number of days of hospice care
大体时间：28 weeks
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28 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Total number of psychotropic medications used
大体时间：28 weeks
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28 weeks
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Total number of increases in psychotropic medications
大体时间：28 weeks
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28 weeks
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Total number of decreases in psychotropic medications
大体时间：28 weeks
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28 weeks
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Total number of cardiac medications taken during the study
大体时间：28 weeks
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28 weeks
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Total number arthritic and anti-inflammatory medications taken during the study
大体时间：28 weeks
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28 weeks
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Total number of analgesic medications taken during the study
大体时间：28 weeks
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28 weeks
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Total number of days hospitalized during the study
大体时间：28 weeks
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28 weeks
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Reasons for hospitalizations and hospital diagnoses during the study
大体时间：28 weeks
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This endpoint will be examined qualitatively; no statistical analysis will be performed but the data will be compiled and reported for illustrative purposes
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28 weeks
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Total number of tests and procedures performed during the hospitalizations
大体时间：28 weeks
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28 weeks
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Changes in Functional Assessment Staging Disability Score (FAST-DS) at subsequent study visits post hospitalization
大体时间：28 weeks
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The FAST-DS assesses the magnitude of progressive functional deterioration by identifying characteristic progressive disabilities in participants with AD. Scores range from 1.0 (normal) to 7f (severe loss of ability, not even able to hold up head independently). Scores are made up of stages (1 through 7) and substages (from a to e for stage 6; from a to f for stage 7). The following scoring for substages is applied: 6a=6.0, 6b=6.2, 6c=6.4, 6d=6.6, 6e=6.8, 7a=7.0, 7b=7.2, 7c=7.4, 7d=7.6, 7e=7.8, 7f=8.0. Additionally, non-consecutive deficits are noted and scored as follows: full stage non-consecutive deficit=1.0, non-consecutive substage deficit=0.2. The overall FAST-DS score = (FAST Stage Score) + (Each Non-Consecutive FAST disability scored as described) |
28 weeks
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Time to death
大体时间：28 weeks
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28 weeks
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Cause of death
大体时间：28 weeks
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This endpoint will be examined qualitatively; no statistical analysis will be performed but the data will be compiled and reported for illustrative purposes
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28 weeks
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Caregiver training and support in relation to mortality
大体时间：28 weeks
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This endpoint will be examined qualitatively; no statistical analysis will be performed but the data will be compiled and reported for illustrative purposes
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28 weeks
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Differences in rate of fecal incontinence
大体时间：28 weeks
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28 weeks
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Differences in rate of urinary incontinence
大体时间：28 weeks
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28 weeks
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合作者和调查者
调查人员
- 首席研究员：Barry Reisberg, MD、NYU Langone Health
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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