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

Sponsor:	Enzymotec
Information provided by:	Enzymotec
ClinicalTrials.gov Identifier:	NCT00736034

Purpose

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.

Condition	Intervention	Phase
Memory Impairment	Dietary Supplement: Phosphatidylserine-Omega3 (SharpPS™-Gold)	Phase IV

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Single-Center, Open-Label Study to Assess the Efficacy of SharpPS™-Gold in Elderly Subjects With Memory Impairment

Resource links provided by NLM:

MedlinePlus related topics: Memory

U.S. FDA Resources

Further study details as provided by Enzymotec:

Primary Outcome Measures:

Change From Baseline in Neuropsychological Computerized Test [ Time Frame: baseline, 15 weeks ] [ Designated as safety issue: No ]
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 [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
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.

Enrollment:	18
Study Start Date:	September 2008
Study Completion Date:	April 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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

Eligibility

Ages Eligible for Study:	65 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00736034

Locations

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

Sponsors and Collaborators

Enzymotec

Investigators

Principal Investigator:

Veronica Vakhapova, MD

Sourasky Medical Center

More Information

No publications provided

Responsible Party:	Inbal Eyal M.Sc, Enzymotec
ClinicalTrials.gov Identifier:	NCT00736034 History of Changes
Other Study ID Numbers:	SharpPS™-Gold 001
Study First Received:	August 14, 2008
Results First Received:	March 4, 2010
Last Updated:	March 26, 2010
Health Authority:	Israel: Ministry of Health

Keywords provided by Enzymotec:

Age Associated Memory Impairment

Additional relevant MeSH terms:

Memory Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on February 09, 2012