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Completed

NCT Number: NCT00736034

The Efficacy of Phosphatidylserine-Omega3 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.

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Key information

Age range

65 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Tel Aviv Sourasky Medical Center, Neurology department

Tel Aviv, 64239, Israel

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Enzymotec

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Aug 15, 2008
Registry last updated
Mar 30, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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