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.
연구 개요
상태
정황
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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New York
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New York, New York, 미국, 10016
- New York University School of Medicine
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Previously participated in the "Memantine and Comprehensive, Individualized, Patient Centered Management of Alzheimer's Disease: A Randomized Controlled Trial" study.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 케이스 컨트롤
- 시간 관점: 회고전
코호트 및 개입
그룹/코호트 |
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Total number of prescription medications taken throughout the study
기간: 28 weeks
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28 weeks
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Total number of hospitalizations
기간: 28 weeks
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28 weeks
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The total number of new medical conditions
기간: 28 weeks
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28 weeks
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Total number of days of hospice care
기간: 28 weeks
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28 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Total number of psychotropic medications used
기간: 28 weeks
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28 weeks
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Total number of increases in psychotropic medications
기간: 28 weeks
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28 weeks
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Total number of decreases in psychotropic medications
기간: 28 weeks
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28 weeks
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Total number of cardiac medications taken during the study
기간: 28 weeks
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28 weeks
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Total number arthritic and anti-inflammatory medications taken during the study
기간: 28 weeks
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28 weeks
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Total number of analgesic medications taken during the study
기간: 28 weeks
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28 weeks
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Total number of days hospitalized during the study
기간: 28 weeks
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28 weeks
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Reasons for hospitalizations and hospital diagnoses during the study
기간: 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
기간: 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
기간: 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
기간: 28 weeks
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28 weeks
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Cause of death
기간: 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
기간: 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
기간: 28 weeks
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28 weeks
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Differences in rate of urinary incontinence
기간: 28 weeks
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28 weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: Barry Reisberg, MD, NYU Langone Health
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .