Clinical trial NCT02854917: Memantine and Comprehensive, Individualized, Patient Centered Management of Alzheimer's Disease: Health Outcome
Official title: Memantine and Comprehensive, Individualized, Patient Centered Management of Alzheimer's Disease: A Randomized Controlled Trial: Further Study, Health Outcome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer Disease
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Forest Laboratories
name: Fisher Center for Alzheimer's Research Foundation
First posted: 2016-08-04
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

Brief 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.


Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Total number of prescription medications taken throughout the study
timeFrame: 28 weeks
measure: Total number of hospitalizations
timeFrame: 28 weeks
measure: The total number of new medical conditions
timeFrame: 28 weeks
measure: Total number of days of hospice care
timeFrame: 28 weeks
Secondary outcomes:
measure: Total number of psychotropic medications used
timeFrame: 28 weeks
measure: Total number of increases in psychotropic medications
timeFrame: 28 weeks
measure: Total number of decreases in psychotropic medications
timeFrame: 28 weeks
measure: Total number of cardiac medications taken during the study
timeFrame: 28 weeks
measure: Total number arthritic and anti-inflammatory medications taken during the study
timeFrame: 28 weeks
measure: Total number of analgesic medications taken during the study
timeFrame: 28 weeks
measure: Total number of days hospitalized during the study
timeFrame: 28 weeks
measure: Reasons for hospitalizations and hospital diagnoses during the study
timeFrame: 28 weeks
measure: Total number of tests and procedures performed during the hospitalizations
timeFrame: 28 weeks
measure: Changes in Functional Assessment Staging Disability Score (FAST-DS) at subsequent study visits post hospitalization
timeFrame: 28 weeks
measure: Time to death
timeFrame: 28 weeks
measure: Cause of death
timeFrame: 28 weeks
measure: Caregiver training and support in relation to mortality
timeFrame: 28 weeks
measure: Differences in rate of fecal incontinence
timeFrame: 28 weeks
measure: Differences in rate of urinary incontinence
timeFrame: 28 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Barry Reisberg, MD
role: PRINCIPAL_INVESTIGATOR
References: