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

March 26, 2010 updated by: Enzymotec

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

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.

Study Overview

Status

Completed

Conditions

Memory Impairment

Intervention / Treatment

Dietary supplement: Phosphatidylserine-Omega3 (SharpPS™-Gold)

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Israel
- - Tel Aviv, Israel, 64239
    - The Tel Aviv Sourasky Medical Center, Neurology department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 90 years (Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Neuropsychological Computerized Test Time Frame: baseline, 15 weeks	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Global Impression of Change (CGI-C)Scale Time Frame: 15 weeks	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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Enzymotec

Investigators

Principal Investigator: Veronica Vakhapova, MD, Sourasky Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

August 14, 2008

First Submitted That Met QC Criteria