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NCT Number: NCT02854917

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

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

New York University School of Medicine

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Total number of prescription medications taken throughout the study

    Time frame: 28 weeks

  2. Total number of hospitalizations

    Time frame: 28 weeks

  3. The total number of new medical conditions

    Time frame: 28 weeks

  4. Total number of days of hospice care

    Time frame: 28 weeks

Secondary outcomes

  1. Total number of psychotropic medications used

    Time frame: 28 weeks

  2. Total number of increases in psychotropic medications

    Time frame: 28 weeks

  3. Total number of decreases in psychotropic medications

    Time frame: 28 weeks

  4. Total number of cardiac medications taken during the study

    Time frame: 28 weeks

  5. Total number arthritic and anti-inflammatory medications taken during the study

    Time frame: 28 weeks

  6. Total number of analgesic medications taken during the study

    Time frame: 28 weeks

  7. Total number of days hospitalized during the study

    Time frame: 28 weeks

  8. Reasons for hospitalizations and hospital diagnoses during the study

    Time frame: 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

  9. Total number of tests and procedures performed during the hospitalizations

    Time frame: 28 weeks

  10. Changes in Functional Assessment Staging Disability Score (FAST-DS) at subsequent study visits post hospitalization

    Time frame: 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)

  11. Time to death

    Time frame: 28 weeks

  12. Cause of death

    Time frame: 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

  13. Caregiver training and support in relation to mortality

    Time frame: 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

  14. Differences in rate of fecal incontinence

    Time frame: 28 weeks

  15. Differences in rate of urinary incontinence

    Time frame: 28 weeks

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • Fisher Center for Alzheimer's Research Foundation
  • Forest Laboratories

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 4, 2016
Registry last updated
Jan 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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