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.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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New York
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New York, New York, Estados Unidos, 10016
- New York University School of Medicine
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Previously participated in the "Memantine and Comprehensive, Individualized, Patient Centered Management of Alzheimer's Disease: A Randomized Controlled Trial" study.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Control de caso
- Perspectivas temporales: Retrospectivo
Cohortes e Intervenciones
Grupo / 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Total number of prescription medications taken throughout the study
Periodo de tiempo: 28 weeks
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28 weeks
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Total number of hospitalizations
Periodo de tiempo: 28 weeks
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28 weeks
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The total number of new medical conditions
Periodo de tiempo: 28 weeks
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28 weeks
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Total number of days of hospice care
Periodo de tiempo: 28 weeks
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28 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Total number of psychotropic medications used
Periodo de tiempo: 28 weeks
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28 weeks
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Total number of increases in psychotropic medications
Periodo de tiempo: 28 weeks
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28 weeks
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Total number of decreases in psychotropic medications
Periodo de tiempo: 28 weeks
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28 weeks
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Total number of cardiac medications taken during the study
Periodo de tiempo: 28 weeks
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28 weeks
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Total number arthritic and anti-inflammatory medications taken during the study
Periodo de tiempo: 28 weeks
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28 weeks
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Total number of analgesic medications taken during the study
Periodo de tiempo: 28 weeks
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28 weeks
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Total number of days hospitalized during the study
Periodo de tiempo: 28 weeks
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28 weeks
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Reasons for hospitalizations and hospital diagnoses during the study
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 28 weeks
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28 weeks
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Cause of death
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 28 weeks
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28 weeks
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Differences in rate of urinary incontinence
Periodo de tiempo: 28 weeks
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28 weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Barry Reisberg, MD, NYU Langone Health
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 12444
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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