Memantine and Comprehensive, Individualized, Patient Centered Management of Alzheimer's Disease: Health Outcome
- Conditions
- Alzheimer Disease
- Registration Number
- NCT02854917
- Lead Sponsor
- NYU Langone Health
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- Previously participated in the "Memantine and Comprehensive, Individualized, Patient Centered Management of Alzheimer's Disease: A Randomized Controlled Trial" study.
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Total number of hospitalizations 28 weeks The total number of new medical conditions 28 weeks Total number of prescription medications taken throughout the study 28 weeks Total number of days of hospice care 28 weeks
- Secondary Outcome Measures
Name Time Method Total number of cardiac medications taken during the study 28 weeks Time to death 28 weeks Differences in rate of fecal incontinence 28 weeks Total number of psychotropic medications used 28 weeks Total number of analgesic medications taken during the study 28 weeks Total number arthritic and anti-inflammatory medications taken during the study 28 weeks Total number of tests and procedures performed during the hospitalizations 28 weeks Cause of death 28 weeks This endpoint will be examined qualitatively; no statistical analysis will be performed but the data will be compiled and reported for illustrative purposes
Caregiver training and support in relation to mortality 28 weeks This endpoint will be examined qualitatively; no statistical analysis will be performed but the data will be compiled and reported for illustrative purposes
Differences in rate of urinary incontinence 28 weeks Total number of days hospitalized during the study 28 weeks Reasons for hospitalizations and hospital diagnoses during the study 28 weeks This endpoint will be examined qualitatively; no statistical analysis will be performed but the data will be compiled and reported for illustrative purposes
Changes in Functional Assessment Staging Disability Score (FAST-DS) at subsequent study visits post hospitalization 28 weeks 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)Total number of increases in psychotropic medications 28 weeks Total number of decreases in psychotropic medications 28 weeks
Trial Locations
- Locations (1)
New York University School of Medicine
🇺🇸New York, New York, United States