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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02854917
• Other study ID #: 12444
• Status: Completed
• Phase: N/A
• First received: August 1, 2016
• Last updated: January 23, 2018
• Start date: July 2016
• Est. completion date: January 5, 2018

Study information

• Verified date: January 2018
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 5, 2018
• Est. primary completion date: January 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

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

Related Conditions & MeSH terms

• Alzheimer Disease

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
New York University School of Medicine	Fisher Center for Alzheimer's Research Foundation, Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total number of prescription medications taken throughout the study		28 weeks
Primary	Total number of hospitalizations		28 weeks
Primary	The total number of new medical conditions		28 weeks
Primary	Total number of days of hospice care		28 weeks
Secondary	Total number of psychotropic medications used		28 weeks
Secondary	Total number of increases in psychotropic medications		28 weeks
Secondary	Total number of decreases in psychotropic medications		28 weeks
Secondary	Total number of cardiac medications taken during the study		28 weeks
Secondary	Total number arthritic and anti-inflammatory medications taken during the study		28 weeks
Secondary	Total number of analgesic medications taken during the study		28 weeks
Secondary	Total number of days hospitalized during the study		28 weeks
Secondary	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
Secondary	Total number of tests and procedures performed during the hospitalizations		28 weeks
Secondary	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
Secondary	Time to death		28 weeks
Secondary	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
Secondary	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
Secondary	Differences in rate of fecal incontinence		28 weeks
Secondary	Differences in rate of urinary incontinence		28 weeks

External Links

•   ClinicalTrials.gov record for the previously completed RCT