- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02854917
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.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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New York
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New York, New York, États-Unis, 10016
- New York University School of Medicine
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Previously participated in the "Memantine and Comprehensive, Individualized, Patient Centered Management of Alzheimer's Disease: A Randomized Controlled Trial" study.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cas-témoins
- Perspectives temporelles: Rétrospective
Cohortes et interventions
Groupe / Cohorte |
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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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Total number of prescription medications taken throughout the study
Délai: 28 weeks
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28 weeks
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Total number of hospitalizations
Délai: 28 weeks
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28 weeks
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The total number of new medical conditions
Délai: 28 weeks
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28 weeks
|
Total number of days of hospice care
Délai: 28 weeks
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28 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Total number of psychotropic medications used
Délai: 28 weeks
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28 weeks
|
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Total number of increases in psychotropic medications
Délai: 28 weeks
|
28 weeks
|
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Total number of decreases in psychotropic medications
Délai: 28 weeks
|
28 weeks
|
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Total number of cardiac medications taken during the study
Délai: 28 weeks
|
28 weeks
|
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Total number arthritic and anti-inflammatory medications taken during the study
Délai: 28 weeks
|
28 weeks
|
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Total number of analgesic medications taken during the study
Délai: 28 weeks
|
28 weeks
|
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Total number of days hospitalized during the study
Délai: 28 weeks
|
28 weeks
|
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Reasons for hospitalizations and hospital diagnoses during the study
Délai: 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
|
28 weeks
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Total number of tests and procedures performed during the hospitalizations
Délai: 28 weeks
|
28 weeks
|
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Changes in Functional Assessment Staging Disability Score (FAST-DS) at subsequent study visits post hospitalization
Délai: 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
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Time to death
Délai: 28 weeks
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28 weeks
|
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Cause of death
Délai: 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
|
28 weeks
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Caregiver training and support in relation to mortality
Délai: 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
|
28 weeks
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Differences in rate of fecal incontinence
Délai: 28 weeks
|
28 weeks
|
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Differences in rate of urinary incontinence
Délai: 28 weeks
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28 weeks
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Barry Reisberg, MD, NYU Langone Health
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 12444
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .