Memantine and Comprehensive, Individualized, Patient Centered Management of Alzheimer's Disease: Health Outcome

Study Overview
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Brief Summary
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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.

Official Title
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Memantine and Comprehensive, Individualized, Patient Centered Management of Alzheimer's Disease: A Randomized Controlled Trial: Further Study, Health Outcome

Conditions
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Alzheimer Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Previously participated in the Memantine and Comprehensive, Individualized, Patient Centered Management of Alzheimer's Disease: A Randomized Controlled Trial study.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Memantine Alone<br>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. | |
| Memantine plus Individualized Management of AD<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of prescription medications taken throughout the study |  | 28 weeks | 
| Total number of hospitalizations |  | 28 weeks | 
| The total number of new medical conditions |  | 28 weeks | 
| Total number of days of hospice care |  | 28 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of psychotropic medications used |  | 28 weeks | 
| Total number of increases in psychotropic medications |  | 28 weeks | 
| Total number of decreases in psychotropic medications |  | 28 weeks | 
| Total number of cardiac medications taken during the study |  | 28 weeks | 
| Total number arthritic and anti-inflammatory medications taken during the study |  | 28 weeks | 
| Total number of analgesic medications taken during the study |  | 28 weeks | 
| Total number of days hospitalized during the study |  | 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 | 28 weeks | 
| Total number of tests and procedures performed during the hospitalizations |  | 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) | 28 weeks | 
| Time to death |  | 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 | 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 | 28 weeks | 
| Differences in rate of fecal incontinence |  | 28 weeks | 
| Differences in rate of urinary incontinence |  | 28 weeks |