- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00146263
Computerized Cognitive Training in the Elderly (CogTrain)
The Effect of Computerized Cognitive Training on Neuropsychological Measures of Cognitive Function in the Elderly
Background:
The aging of the population has lead to a significant increase in the number of older people suffering from cognitive impairment and dementia. The present lack of effective drug therapy for these conditions makes it imperative to investigate other potential therapeutic interventions.
Cognitive training has been described as possibly useful in improving cognitive function in elderly subjects with mild impairment and early dementia. However, there have been few well-designed studies to date and the results are equivocal. Most studies have relied on the use of paper-based neuropsychological assessment instruments with limited accuracy and reproducibility. The investigators have developed a validated computerized neuropsychological assessment battery with increased test-retest reliability.
The purpose of this study is to assess the efficacy of a computerized training program on cognitive function in older persons with normal cognition, mild cognitive impairment, and early dementia.
Description:
A randomized prospective AB/BA crossover study.
Methods:
Eligible males and females aged 60 years and older following initial computerized neuropsychological assessment will be randomized to receive either a 12-session computerized cognitive training program, or no treatment. Repeat neuropsychological assessment will be followed by a 4-week no treatment phase, reassessment and crossover phase.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Background
In recent years there has been an increase in the elderly population. This fact has led to a significant number of people suffering from diseases which are associated with old age, amongst which is dementia.
The medical treatment of dementia is limited in its effectiveness and thus it is important to investigate other methods of therapy. One of the possible options to preserve the cognitive function is to apply cognitive exercise. If these exercises can improve cognitive expertise, it would open new vistas of treatment for dementia patients.
From a few research projects that have taken place on the subject, it has not been proved that cognitive exercising has been of use to patients suffering from mild dementia mainly because of methodological restraints. Thus it is necessary to undertake controlled random research on the subject.
The assessment of the cognitive state and the change in its status demands sensitive measurements. Objective and accurate computerized neuro-physiological testing like "Mindstream ®" and computer hardware are readably available. This technique enhances motivation and encourages participation.
Purpose of the work:
To evaluate the influence of computerized cognitive exercise on the cognitive function of the elderly suffering from mild dementia.
Methods:
IA randomized controlled study using a crossover AB/BA design will be performed. The intervention group will participate in a 12-session twice weekly intervention using the "Savyon" computerized cognitive training program (developed by the Melabev organization Jerusalem), which includes memory, language, arithmetic exercises and puzzles matching colors and shapes. The control group will continue with usual activities with no additional cognitive stimulation. Following a 4-week "washout" phase the groups will be switched in an AB/BA crossover design. A total of 150 subjects with mild cognitive impairment or early dementia will be included. Primary outcome measure will be the Mindstreams® (NeuroTrax Corp., N.Y.) computerized cognitive assessment battery performed initially, at 12 weeks, 16 weeks, 28 weeks.
For each Mindstreams ® index, the differences were compared the testing within each group utilizing "Wilcoxon Signed Ranks test" and between the groups utilizing "Mann-Whitney U test".
Tipo de estudio
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Beersheva, Israel
- Beersheva Mental Health Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Age: above 60 years old
Exclusion Criteria:
- Visual impairment
- Educational inability to perform training
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Savyon
Computerized cognitive training using the Savyon software
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Computerized cognitive training
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Comparador de placebos: Control
Usual activity
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Usual activity
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Computerized cognitive assessment using the Mindstreams battery
Periodo de tiempo: 12 weeks
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Changes in cognitive function including memory, executive function, visual spatial and attention.
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12 weeks
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Colaboradores e Investigadores
Patrocinador
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
- BMHC-4018CTIL
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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