The Efficacy of Phosphatidylserine-Omega3 in Elderly With Age Associated Memory Impairment
A Single-Center, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy of Phosphatidylserine-Omega3 in Elderly With Age Associated Memory Impairment
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Tipo de estudio
Tipo de estudio
Inscripción (Actual)
Inscripción
Fase
Fase
- Fase 4
Contactos y Ubicaciones
Ubicaciones de estudio
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Tel Aviv, Israel, 64239
- The Tel Aviv Sourasky Medical Center, Neurology department
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Ability to give written informed consent
- Age: 90≥ years ≥50
- Gender: male and female
- CDR ≤ 0.5
- Complaints of memory loss reflected in such everyday problems as difficulty remembering names of individuals following introduction, misplacing objects, difficulty remembering multiple items to be purchased or multiple tasks to be performed, difficulty remembering telephone numbers or zip codes, and difficulty recalling information quickly or following distraction. Onset of memory loss must be described as gradual, without sudden worsening in recent months. Complaints of memory loss to be assessed by the MAC-Q scale.
- Mini-Mental State Examination (MMSE) ≥27 for subjects with college education (BA) and ≥ 26 for all others
- Memory test performance that is at least 1 SD below the mean established for young adults on at least one neuropsychological subtest of NexAde.
- Language: Subjects must be able to read, write and speak Hebrew.
- Ability to perform tests and interviews
Exclusion Criteria:
- Evidence of delirium, confusion, or other disturbances of consciousness
- Any Neurological disorder that could produce cognitive deterioration. Such disorders include AD, Parkinson's disease, stroke, intracranial hemorrhage, local brain lesions including tumors, and normal pressure hydrocephalus
- History of any infective or inflammatory brain disease including those of viral, fungal, or syphilitic etiologies
- Evidence of significant cerebral vascular pathology
- Head injury immediately preceding cognitive deterioration.
- Current psychiatric diagnosis according to DSM IV criteria of depression, mania, or any other major psychiatric disorder
- Current diagnosis or history of alcoholism or drug dependence.
- Evidence of depression as determined by the Geriatric Depression Scale (short version) score of 5 or more.
- Any medical disorder that could produce cognitive deterioration including renal, respiratory, cardiac, and hepatic disease, diabetes mellitus, endocrine, metabolic or hematological disturbances unless well controlled, and malignancy not in remission for more than two years
- Use of psychotropic drug or any other drug or supplement that may significantly affect cognitive functioning during the month prior to psychometric testing.
- Use of any experimental medication within 1 month prior to screening or as concomitant medications.
- Subject has a history of hypersensitivity or allergy to fish or fish oil or soy.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
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Comparador activo: PS-Omega3
Phosphatidylserine-Omega3, 300mg/day 15 wk
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Phosphatidylserine-Omega3 capsules 3x100mg/day 15 wk.
Next, follow up phase, open label,1x100mg/day, 15 wk
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Comparador de placebos: Placebo
Cellulose tainted with fishy odor, 3 capsules/day
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Placebo cellulose tainted with fishy odor capsules 3x100mg/day 15 wk
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¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change From Baseline in Rey Auditory Verbal Learning Test
Periodo de tiempo: baseline, 15 wk
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A widely used, brief, easy to understand scale to evaluate verbal learning and memory.
The score is presented as the number of words correctly recalled (0 is worse, 15 is best).The total learning task score ranges from 0 to 45 words(0 is worse, 45 is best).
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baseline, 15 wk
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Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Blood Work
Periodo de tiempo: baseline,15 wk
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baseline,15 wk
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Trail Making Test
Periodo de tiempo: Baseline, 15 weeks
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Baseline, 15 weeks
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Computerized Cognitive Assessment Tool
Periodo de tiempo: baseline, 15 weeks
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baseline, 15 weeks
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Clinical Global Impression of Change (CGI-C)Scale
Periodo de tiempo: 7 weeks, 15 weeks
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The Clinical Global Impression of Change (CGI-C)scale is designed to record the clinician's global impression of change.
Global improvement score ranges from 1 = "Very much improved", through 4 = "No change", to 7 = "Very much worse".
Participants who experienced an improvement (scores 1, 2 or 3) in at least one of the two visits (following 7 or 15 weeks of treatment) were classified as improved over the treatment period (with the exception of participants reporting improvement following 7 weeks and deterioration at endpoint, who were NOT rated as improved)
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7 weeks, 15 weeks
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Change From Baseline in Rey Osterrieth Complex Figure Test
Periodo de tiempo: baseline, 15 weeks
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A widely used neuropsychological tool for the evaluation of visuospatial constructional ability and visual memory.
Both the time to complete the task (copy time)and the accuracy (immediate and delayed recall) were used as measures for the analysis.
Accuracy range score is 0-36 points (0 is worse, 36 is best).
Copy time is expressed in seconds (less time to copy indicates better performance).
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baseline, 15 weeks
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Colaboradores e Investigadores
Patrocinador
Patrocinador
Investigadores
Investigadores
- Director de estudio: Amos Korczyn, MD, Sourasky Medical Center
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización primaria
Finalización del estudio (Actual)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- Memory_PS 001
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