The Efficacy of Phosphatidylserine-Omega3 in Elderly Subjects With Memory Impairment

Enzymotec

Status and phase: Completed; Phase 4

Conditions: Memory Impairment

Treatments: Dietary Supplement: Phosphatidylserine-Omega3 (SharpPS™-Gold)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00736034

SharpPS™-Gold 001

Details and patient eligibility

About

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, open-label 15 weeks duration trial to assess efficacy of Phosphatidylserine-Omega3 in elderly subjects with memory impairment.

Enrollment: 18 patients

Sex: All

Ages: 65 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

INCLUSION CRITERIA

1. Ability to give written informed consent
2. Age: 90≥ years ≥65
3. Gender: male and female.
4. Clinical Dementia Rating Scale (CDR) ≤ 0.5
5. Mini-Mental State Examination (MMSE) ≥ 26
6. 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
7. Language: Subjects must be able to read, write and speak Hebrew.
8. Ability to perform tests and interviews.

EXCLUSION CRITERIA

1. Evidence of delirium, confusion, or other disturbances of consciousness.
2. 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
3. History of any infective or inflammatory brain disease including those of viral, fungal, or syphilitic etiologies.
4. Head injury immediately preceding cognitive deterioration.
5. 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.
6. Current diagnosis or history of alcoholism or drug dependence.
7. 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.
8. Use of psychotropic drug or any other drug or supplement that may significantly affect cognitive functioning during the month prior to psychometric testing.
9. Use of any experimental medication within 1 month prior to screening or as concomitant medications.
10. History of hypersensitivity or allergy to fish or fish oil.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)