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

Primary Purpose

Age Associated Memory Impairment

Status
Completed
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
PS-Omega3
Placebo
Sponsored by
Enzymotec
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age Associated Memory Impairment

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • The Tel Aviv Sourasky Medical Center, Neurology department

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

PS-Omega3

Placebo

Arm Description

Phosphatidylserine-Omega3, 300mg/day 15 wk

Cellulose tainted with fishy odor, 3 capsules/day

Outcomes

Primary Outcome Measures

Change From Baseline in Rey Auditory Verbal Learning Test
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

Blood Work
Trail Making Test
Computerized Cognitive Assessment Tool
Clinical Global Impression of Change (CGI-C)Scale
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)
Change From Baseline in Rey Osterrieth Complex Figure Test
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).

Full Information

First Posted
February 20, 2007
Last Updated
January 3, 2010
Sponsor
Enzymotec
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1. Study Identification

Unique Protocol Identification Number
NCT00437983
Brief Title
The Efficacy of Phosphatidylserine-Omega3 in Elderly With Age Associated Memory Impairment
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 Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Enzymotec

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age Associated Memory Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
157 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PS-Omega3
Arm Type
Active Comparator
Arm Description
Phosphatidylserine-Omega3, 300mg/day 15 wk
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Cellulose tainted with fishy odor, 3 capsules/day
Intervention Type
Dietary Supplement
Intervention Name(s)
PS-Omega3
Intervention Description
Phosphatidylserine-Omega3 capsules 3x100mg/day 15 wk. Next, follow up phase, open label,1x100mg/day, 15 wk
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo cellulose tainted with fishy odor capsules 3x100mg/day 15 wk
Primary Outcome Measure Information:
Title
Change From Baseline in Rey Auditory Verbal Learning Test
Description
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).
Time Frame
baseline, 15 wk
Secondary Outcome Measure Information:
Title
Blood Work
Time Frame
baseline,15 wk
Title
Trail Making Test
Time Frame
Baseline, 15 weeks
Title
Computerized Cognitive Assessment Tool
Time Frame
baseline, 15 weeks
Title
Clinical Global Impression of Change (CGI-C)Scale
Description
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)
Time Frame
7 weeks, 15 weeks
Title
Change From Baseline in Rey Osterrieth Complex Figure Test
Description
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).
Time Frame
baseline, 15 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Ability to give written informed consent Age: 90≥ years ≥50 Gender: male and female CDR ≤ 0.5 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. Mini-Mental State Examination (MMSE) ≥27 for subjects with college education (BA) and ≥ 26 for all others Memory test performance that is at least 1 SD below the mean established for young adults on at least one neuropsychological subtest of NexAde. 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 Evidence of significant cerebral vascular pathology Head injury immediately preceding cognitive deterioration. Current psychiatric diagnosis according to DSM IV criteria of depression, mania, or any other major psychiatric disorder Current diagnosis or history of alcoholism or drug dependence. Evidence of depression as determined by the Geriatric Depression Scale (short version) score of 5 or more. 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. Subject has a history of hypersensitivity or allergy to fish or fish oil or soy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amos Korczyn, MD
Organizational Affiliation
Sourasky Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
The Tel Aviv Sourasky Medical Center, Neurology department
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
21711517
Citation
Vakhapova V, Richter Y, Cohen T, Herzog Y, Korczyn AD. Safety of phosphatidylserine containing omega-3 fatty acids in non-demented elderly: a double-blind placebo-controlled trial followed by an open-label extension. BMC Neurol. 2011 Jun 28;11:79. doi: 10.1186/1471-2377-11-79.
Results Reference
derived

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

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