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

Primary Purpose

Memory Impairment

Status

Completed

Phase

Phase 4

Locations

Israel

Study Type

Interventional

Intervention

Phosphatidylserine-Omega3 (SharpPS™-Gold)

About this trial

This is an interventional treatment trial for Memory Impairment focused on measuring Age Associated Memory Impairment

Eligibility Criteria

65 Years - 90 Years (Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

The Tel Aviv Sourasky Medical Center, Neurology department

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT00736034

First Posted

August 14, 2008

Last Updated

March 26, 2010

Sponsor

Enzymotec

1. Study Identification

Unique Protocol Identification Number

NCT00736034

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2009

Overall Recruitment Status

Completed

Study Start Date

September 2008 (undefined)

Primary Completion Date

March 2009 (Actual)

Study Completion Date

April 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Enzymotec

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Memory Impairment

Keywords

Age Associated Memory Impairment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Dietary Supplement

Intervention Name(s)

Phosphatidylserine-Omega3 (SharpPS™-Gold)

Intervention Description

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

Primary Outcome Measure Information:

Title

Change From Baseline in Neuropsychological Computerized Test

Description

Time Frame

baseline, 15 weeks

Secondary Outcome Measure Information:

Title

Clinical Global Impression of Change (CGI-C)Scale

Description

Time Frame

15 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Veronica Vakhapova, MD

Organizational Affiliation

Sourasky Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Tel Aviv Sourasky Medical Center, Neurology department

City

Tel Aviv

ZIP/Postal Code

64239

Country

Israel

12. IPD Sharing Statement

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

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