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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00736034
First Posted: August 15, 2008
Last Update Posted: March 30, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Enzymotec
  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 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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:


Further study details as provided by Enzymotec:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


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:
    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
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   65 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Inbal Eyal M.Sc, Enzymotec
ClinicalTrials.gov Identifier: NCT00736034     History of Changes
Other Study ID Numbers: SharpPS™-Gold 001
First Submitted: August 14, 2008
First Posted: August 15, 2008
Results First Submitted: March 4, 2010
Results First Posted: March 24, 2010
Last Update Posted: March 30, 2010
Last Verified: April 2009

Keywords provided by Enzymotec:
Age Associated Memory Impairment

Additional relevant MeSH terms:
Memory Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms