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

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ClinicalTrials.gov Identifier: NCT00437983
Recruitment Status : Completed
First Posted : February 21, 2007
Results First Posted : November 25, 2009
Last Update Posted : January 5, 2010
Sponsor:
Information provided by:
Enzymotec

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

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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

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 ]
    A widely used, brief, easy to understand scale to evaluate verbal learning and memory. The score is presented as the number of words correctly recalled (0 is worse, 15 is best).The total learning task score ranges from 0 to 45 words(0 is worse, 45 is best).


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 ]
    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) in at least one of the two visits (following 7 or 15 weeks of treatment) were classified as improved over the treatment period (with the exception of participants reporting improvement following 7 weeks and deterioration at endpoint, who were NOT rated as improved)

  5. Change From Baseline in Rey Osterrieth Complex Figure Test [ Time Frame: baseline, 15 weeks ]
    A widely used neuropsychological tool for the evaluation of visuospatial constructional ability and visual memory. Both the time to complete the task (copy time)and the accuracy (immediate and delayed recall) were used as measures for the analysis. Accuracy range score is 0-36 points (0 is worse, 36 is best). Copy time is expressed in seconds (less time to copy indicates better performance).



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

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 ClinicalTrials.gov identifier (NCT number): NCT00437983


Locations
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Israel
The Tel Aviv Sourasky Medical Center, Neurology department
Tel Aviv, Israel, 64239
Sponsors and Collaborators
Enzymotec
Investigators
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Study Director: Amos Korczyn, MD Sourasky Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yael Richter PhD, Enzymotec
ClinicalTrials.gov Identifier: NCT00437983    
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:
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Memory Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases