The Efficacy of Phosphatidylserine-Omega3 in Elderly With Age Associated Memory Impairment

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. Identifier: NCT00437983
Recruitment Status : Completed
First Posted : February 21, 2007
Results First Posted : November 25, 2009
Last Update Posted : January 5, 2010
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Brief Summary:
The primary objective of this trial is to assess the ability of an oral administration of Phosphatidylserine-Omega3 to improve attention and memory complaints in comparison to placebo in age associated memory impaired subjects.

Condition or disease Intervention/treatment Phase
Age Associated Memory Impairment Dietary Supplement: PS-Omega3 Dietary Supplement: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 157 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Single-Center, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy of Phosphatidylserine-Omega3 in Elderly With Age Associated Memory Impairment
Study Start Date : April 2007
Actual Primary Completion Date : June 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: PS-Omega3
Phosphatidylserine-Omega3, 300mg/day 15 wk
Dietary Supplement: PS-Omega3
Phosphatidylserine-Omega3 capsules 3x100mg/day 15 wk. Next, follow up phase, open label,1x100mg/day, 15 wk
Placebo Comparator: Placebo
Cellulose tainted with fishy odor, 3 capsules/day
Dietary Supplement: Placebo
Placebo cellulose tainted with fishy odor capsules 3x100mg/day 15 wk

Primary Outcome Measures :
  1. Change From Baseline in Rey Auditory Verbal Learning Test [ Time Frame: baseline, 15 wk ]

Secondary Outcome Measures :
  1. Blood Work [ Time Frame: baseline,15 wk ]
  2. Trail Making Test [ Time Frame: Baseline, 15 weeks ]
  3. Computerized Cognitive Assessment Tool [ Time Frame: baseline, 15 weeks ]
  4. Clinical Global Impression of Change (CGI-C)Scale [ Time Frame: 7 weeks, 15 weeks ]
  5. Change From Baseline in Rey Osterrieth Complex Figure Test [ Time Frame: baseline, 15 weeks ]

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Ability to give written informed consent
  2. Age: 90≥ years ≥50
  3. Gender: male and female
  4. CDR ≤ 0.5
  5. Complaints of memory loss reflected in such everyday problems as difficulty remembering names of individuals following introduction, misplacing objects, difficulty remembering multiple items to be purchased or multiple tasks to be performed, difficulty remembering telephone numbers or zip codes, and difficulty recalling information quickly or following distraction. Onset of memory loss must be described as gradual, without sudden worsening in recent months. Complaints of memory loss to be assessed by the MAC-Q scale.
  6. Mini-Mental State Examination (MMSE) ≥27 for subjects with college education (BA) and ≥ 26 for all others
  7. Memory test performance that is at least 1 SD below the mean established for young adults on at least one neuropsychological subtest of NexAde.
  8. Language: Subjects must be able to read, write and speak Hebrew.
  9. 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. Evidence of significant cerebral vascular pathology
  5. Head injury immediately preceding cognitive deterioration.
  6. Current psychiatric diagnosis according to DSM IV criteria of depression, mania, or any other major psychiatric disorder
  7. Current diagnosis or history of alcoholism or drug dependence.
  8. Evidence of depression as determined by the Geriatric Depression Scale (short version) score of 5 or more.
  9. 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
  10. Use of psychotropic drug or any other drug or supplement that may significantly affect cognitive functioning during the month prior to psychometric testing.
  11. Use of any experimental medication within 1 month prior to screening or as concomitant medications.
  12. Subject has a history of hypersensitivity or allergy to fish or fish oil or soy.

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 identifier (NCT number): NCT00437983

The Tel Aviv Sourasky Medical Center, Neurology department
Tel Aviv, Israel, 64239
Sponsors and Collaborators
Study Director: Amos Korczyn, MD Sourasky Medical Center

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Yael Richter PhD, Enzymotec Identifier: NCT00437983     History of Changes
Other Study ID Numbers: Memory_PS 001
First Posted: February 21, 2007    Key Record Dates
Results First Posted: November 25, 2009
Last Update Posted: January 5, 2010
Last Verified: January 2010

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