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.
Studienübersicht
Status
Bedingungen
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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New York
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New York, New York, Vereinigte Staaten, 10016
- New York University School of Medicine
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
Inclusion Criteria:
- Previously participated in the "Memantine and Comprehensive, Individualized, Patient Centered Management of Alzheimer's Disease: A Randomized Controlled Trial" study.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: Fallkontrolle
- Zeitperspektiven: Retrospektive
Kohorten und Interventionen
Gruppe / Kohorte |
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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.
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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.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
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Total number of prescription medications taken throughout the study
Zeitfenster: 28 weeks
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28 weeks
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Total number of hospitalizations
Zeitfenster: 28 weeks
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28 weeks
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The total number of new medical conditions
Zeitfenster: 28 weeks
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28 weeks
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Total number of days of hospice care
Zeitfenster: 28 weeks
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28 weeks
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Total number of psychotropic medications used
Zeitfenster: 28 weeks
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28 weeks
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Total number of increases in psychotropic medications
Zeitfenster: 28 weeks
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28 weeks
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Total number of decreases in psychotropic medications
Zeitfenster: 28 weeks
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28 weeks
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Total number of cardiac medications taken during the study
Zeitfenster: 28 weeks
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28 weeks
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Total number arthritic and anti-inflammatory medications taken during the study
Zeitfenster: 28 weeks
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28 weeks
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Total number of analgesic medications taken during the study
Zeitfenster: 28 weeks
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28 weeks
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Total number of days hospitalized during the study
Zeitfenster: 28 weeks
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28 weeks
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Reasons for hospitalizations and hospital diagnoses during the study
Zeitfenster: 28 weeks
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This endpoint will be examined qualitatively; no statistical analysis will be performed but the data will be compiled and reported for illustrative purposes
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28 weeks
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Total number of tests and procedures performed during the hospitalizations
Zeitfenster: 28 weeks
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28 weeks
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Changes in Functional Assessment Staging Disability Score (FAST-DS) at subsequent study visits post hospitalization
Zeitfenster: 28 weeks
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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
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Time to death
Zeitfenster: 28 weeks
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28 weeks
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Cause of death
Zeitfenster: 28 weeks
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This endpoint will be examined qualitatively; no statistical analysis will be performed but the data will be compiled and reported for illustrative purposes
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28 weeks
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Caregiver training and support in relation to mortality
Zeitfenster: 28 weeks
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This endpoint will be examined qualitatively; no statistical analysis will be performed but the data will be compiled and reported for illustrative purposes
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28 weeks
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Differences in rate of fecal incontinence
Zeitfenster: 28 weeks
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28 weeks
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Differences in rate of urinary incontinence
Zeitfenster: 28 weeks
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28 weeks
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Barry Reisberg, MD, NYU Langone Health
Publikationen und hilfreiche Links
Nützliche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 12444
Plan für individuelle Teilnehmerdaten (IPD)
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Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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