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

NCT ID: NCT00736034

Last Updated: 2010-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2009-04-30

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

Conditions

Memory Impairment

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Phosphatidylserine-Omega3 (SharpPS™-Gold)

Treatment will consist of capsules containing 100 mg phosphatidylserine-Omega3. Dosage: 1 capsule X 3 times daily, with meals. Duration: 15 weeks

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Enzymotec

INDUSTRY

Sponsor Role: lead

Responsible Party

Enzymotec

Principal Investigators

Veronica Vakhapova, MD

Role: PRINCIPAL_INVESTIGATOR

Sourasky Medical Center

Locations

The Tel Aviv Sourasky Medical Center, Neurology department

Tel Aviv, , Israel

Countries

Israel

Other Identifiers

SharpPS™-Gold 001

Identifier Type: -

Identifier Source: org_study_id