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

NCT00736034 | Completed Phase 4 Results

• 1 other identifier: SharpPS™-Gold 001
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Keywords

Age Associated Memory Impairment

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Clinical Global Impression of Change (CGI-C)Scale

  15 weeks

Interventions

Phosphatidylserine-Omega3 (SharpPS™-Gold) DIETARY_SUPPLEMENT

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

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Enzymotec: lead

Study Sites (1)

The Tel Aviv Sourasky Medical Center, Neurology department

Tel Aviv, 64239, Israel

Location

MeSH Terms

Conditions

Memory Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. V. Vakhapova
• Organization: Sourazky Tel-Aviv Medical Center

vedanicek@gmail.com

972-3-6973698

Study Officials

• Veronica Vakhapova, MD

  Sourasky Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 14, 2008
• First Posted: August 15, 2008
• Study Start: September 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: April 1, 2009
• Last Updated: March 30, 2010
• Results First Posted: March 24, 2010

Record last verified: 2009-04

Locations

IL (1)