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

Memory Impairment Clinical Trial

Official title:

A Single-Center, Open-Label Study to Assess the Efficacy of SharpPS™-Gold in Elderly Subjects With Memory Impairment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00736034
• Other study ID #: SharpPS™-Gold 001
• Status: Completed
• Phase: Phase 4
• First received: August 14, 2008
• Last updated: March 26, 2010
• Start date: September 2008
• Est. completion date: April 2009

Study information

• Verified date: April 2009
• Source: Enzymotec
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years to 90 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Memory Disorders
• Memory Impairment

Intervention

Dietary Supplement:
• 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

Locations

Country	Name	City	State
Israel	The Tel Aviv Sourasky Medical Center, Neurology department	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Enzymotec

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Neuropsychological Computerized Test	The computerized neuropsychological assessment software consists of seven separate tasks: symbol spotting, pattern identification, pattern recall, digit-symbol substitution, digits span forward, digits span backward and delayed pattern recall. Based on the results obtained in the single tasks, eight cognitive composite scores are calculated including focused attention, sustained attention, memory recognition & recall, visuospatial learning, spatial short term memory, executive functions and mental flexibility.The total score range is from 0 to 100 points(0 is worse, 100 is best).	baseline, 15 weeks	No
Secondary	Clinical Global Impression of Change (CGI-C)Scale	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) were classified as improved over the treatment period.	15 weeks	No