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.
Study Type
OBSERVATIONAL
Enrollment
20
New York University School of Medicine
New York, New York, United States
Total number of prescription medications taken throughout the study
Time frame: 28 weeks
Total number of hospitalizations
Time frame: 28 weeks
The total number of new medical conditions
Time frame: 28 weeks
Total number of days of hospice care
Time frame: 28 weeks
Total number of psychotropic medications used
Time frame: 28 weeks
Total number of increases in psychotropic medications
Time frame: 28 weeks
Total number of decreases in psychotropic medications
Time frame: 28 weeks
Total number of cardiac medications taken during the study
Time frame: 28 weeks
Total number arthritic and anti-inflammatory medications taken during the study
Time frame: 28 weeks
Total number of analgesic medications taken during the study
Time frame: 28 weeks
Total number of days hospitalized during the study
Time frame: 28 weeks
Reasons for hospitalizations and hospital diagnoses during the study
This endpoint will be examined qualitatively; no statistical analysis will be performed but the data will be compiled and reported for illustrative purposes
Time frame: 28 weeks
Total number of tests and procedures performed during the hospitalizations
Time frame: 28 weeks
Changes in Functional Assessment Staging Disability Score (FAST-DS) at subsequent study visits post hospitalization
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)
Time frame: 28 weeks
Time to death
Time frame: 28 weeks
Cause of death
This endpoint will be examined qualitatively; no statistical analysis will be performed but the data will be compiled and reported for illustrative purposes
Time frame: 28 weeks
Caregiver training and support in relation to mortality
This endpoint will be examined qualitatively; no statistical analysis will be performed but the data will be compiled and reported for illustrative purposes
Time frame: 28 weeks
Differences in rate of fecal incontinence
Time frame: 28 weeks
Differences in rate of urinary incontinence
Time frame: 28 weeks
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