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.

Study Overview

• Status: Completed
• Conditions: Alzheimer Disease

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This retrospective study will only include data from previous participants in the "Memantine and Comprehensive, Individualized, Patient Centered Management of Alzheimer's Disease: A Randomized Controlled Trial" study. In total, 20 participants completed the previous RCT and will have their data included in this retrospective study.

Description

Inclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: Forest Laboratories; Fisher Center for Alzheimer's Research Foundation
• Investigators: Principal Investigator: Barry Reisberg, MD, NYU Langone Health

Publications and helpful links

Helpful Links

• ClinicalTrials.gov record for the previously completed RCT

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Actual): January 5, 2018
• Study Completion (Actual): January 5, 2018

Study Registration Dates

• First Submitted: August 1, 2016
• First Submitted That Met QC Criteria: August 1, 2016
• First Posted (Estimate): August 4, 2016

Study Record Updates

• Last Update Posted (Actual): January 25, 2018
• Last Update Submitted That Met QC Criteria: January 23, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: 12444

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No