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

23. januar 2018 opdateret af: NYU Langone Health

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.

Studieoversigt

Status

Afsluttet

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

20

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • New York
      • New York, New York, Forenede Stater, 10016
        • New York University School of Medicine

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

50 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

Inclusion Criteria:

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Case-Control
  • Tidsperspektiver: Tilbagevirkende kraft

Kohorter og interventioner

Gruppe / kohorte
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Total number of prescription medications taken throughout the study
Tidsramme: 28 weeks
28 weeks
Total number of hospitalizations
Tidsramme: 28 weeks
28 weeks
The total number of new medical conditions
Tidsramme: 28 weeks
28 weeks
Total number of days of hospice care
Tidsramme: 28 weeks
28 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Total number of psychotropic medications used
Tidsramme: 28 weeks
28 weeks
Total number of increases in psychotropic medications
Tidsramme: 28 weeks
28 weeks
Total number of decreases in psychotropic medications
Tidsramme: 28 weeks
28 weeks
Total number of cardiac medications taken during the study
Tidsramme: 28 weeks
28 weeks
Total number arthritic and anti-inflammatory medications taken during the study
Tidsramme: 28 weeks
28 weeks
Total number of analgesic medications taken during the study
Tidsramme: 28 weeks
28 weeks
Total number of days hospitalized during the study
Tidsramme: 28 weeks
28 weeks
Reasons for hospitalizations and hospital diagnoses during the study
Tidsramme: 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
28 weeks
Total number of tests and procedures performed during the hospitalizations
Tidsramme: 28 weeks
28 weeks
Changes in Functional Assessment Staging Disability Score (FAST-DS) at subsequent study visits post hospitalization
Tidsramme: 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)
28 weeks
Time to death
Tidsramme: 28 weeks
28 weeks
Cause of death
Tidsramme: 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
28 weeks
Caregiver training and support in relation to mortality
Tidsramme: 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
28 weeks
Differences in rate of fecal incontinence
Tidsramme: 28 weeks
28 weeks
Differences in rate of urinary incontinence
Tidsramme: 28 weeks
28 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

NYU Langone Health

Samarbejdspartnere

Forest Laboratories
Fisher Center for Alzheimer's Research Foundation

Efterforskere

  • Ledende efterforsker: Barry Reisberg, MD, NYU Langone Health

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2016

Primær færdiggørelse (Faktiske)

5. januar 2018

Studieafslutning (Faktiske)

5. januar 2018

Datoer for studieregistrering

Først indsendt

1. august 2016

Først indsendt, der opfyldte QC-kriterier

1. august 2016

Først opslået (Skøn)

4. august 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. januar 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. januar 2018

Sidst verificeret

1. januar 2018

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 12444

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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