Status:
COMPLETED
The Efficacy of Phosphatidylserine-Omega3 in Elderly Subjects With Memory Impairment
Lead Sponsor:
Enzymotec
Conditions:
Memory Impairment
Eligibility:
All Genders
65-90 years
Phase:
PHASE4
Brief Summary
The primary objective of this trial is to assess the ability of Phosphatidylserine-Omega3 to improve cognitive performance in elderly subjects with memory impairment. This study is a single-center, o...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- Ability to give written informed consent
- Age: 90≥ years ≥65
- Gender: male and female.
- Clinical Dementia Rating Scale (CDR) ≤ 0.5
- Mini-Mental State Examination (MMSE) ≥ 26
- Memory test performance within or below the mean established for adults, with maximum of four neuropsychological subtests of the computerized test scored as 1.5 SD above the mean
- 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.
- Head injury immediately preceding cognitive deterioration.
- Current psychiatric diagnosis according to DSM IV criteria of depression, mania, or any other major psychiatric disorder, or evidence of depression as determined by the Geriatric Depression Scale (GDS15) score of 5 or more.
- Current diagnosis or history of alcoholism or drug dependence.
- 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.
- History of hypersensitivity or allergy to fish or fish oil.
Exclusion
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00736034
Start Date
September 1 2008
End Date
April 1 2009
Last Update
March 30 2010
Active Locations (1)
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1
The Tel Aviv Sourasky Medical Center, Neurology department
Tel Aviv, Israel, 64239