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

This study has been completed.
Sponsor:
Information provided by:
Enzymotec
ClinicalTrials.gov Identifier:
NCT00437983
First received: February 20, 2007
Last updated: January 3, 2010
Last verified: January 2010
  Purpose

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 Intervention Phase
Age Associated Memory Impairment
Dietary Supplement: PS-Omega3
Dietary Supplement: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Enzymotec:

Primary Outcome Measures:
  • Change From Baseline in Rey Auditory Verbal Learning Test [ Time Frame: baseline, 15 wk ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood Work [ Time Frame: baseline,15 wk ] [ Designated as safety issue: Yes ]
  • Trail Making Test [ Time Frame: Baseline, 15 weeks ] [ Designated as safety issue: No ]
  • Computerized Cognitive Assessment Tool [ Time Frame: baseline, 15 weeks ] [ Designated as safety issue: No ]
  • Clinical Global Impression of Change (CGI-C)Scale [ Time Frame: 7 weeks, 15 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in Rey Osterrieth Complex Figure Test [ Time Frame: baseline, 15 weeks ] [ Designated as safety issue: No ]

Enrollment: 157
Study Start Date: April 2007
Study Completion Date: September 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00437983

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

No publications provided by Enzymotec

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yael Richter PhD, Enzymotec
ClinicalTrials.gov Identifier: NCT00437983     History of Changes
Other Study ID Numbers: Memory_PS 001
Study First Received: February 20, 2007
Results First Received: June 30, 2009
Last Updated: January 3, 2010
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on July 23, 2014