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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.
 
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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Age Associated Memory Impairment
Interventions Dietary Supplement: PS-Omega3
Dietary Supplement: Placebo
Enrollment 157
Recruitment Details Participants were recruited through advertisements in senior citizens' homes, hospitals, and newspapers.
Pre-assignment Details  
Arm/Group Title PS-Omega3 Placebo
Hide Arm/Group Description Phosphatidylserine-Omega3, 300mg/day 15 wk Cellulose tainted with fishy odor
Period Title: Overall Study
Started 79 78
Completed 66 65
Not Completed 13 13
Reason Not Completed
Adverse Event             6             6
Protocol Violation             2             1
Withdrawal by Subject             5             6
Arm/Group Title PS-Omega3 Placebo Total
Hide Arm/Group Description Phosphatidylserine-Omega3, 300mg/day 15 wk Cellulose tainted with fishy odor Total of all reporting groups
Overall Number of Baseline Participants 79 78 157
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 79 participants 78 participants 157 participants
72.58  (8.12) 72.46  (8.33) 72.52  (8.20)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 78 participants 157 participants
Female
39
  49.4%
39
  50.0%
78
  49.7%
Male
40
  50.6%
39
  50.0%
79
  50.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Israel Number Analyzed 79 participants 78 participants 157 participants
79 78 157
1.Primary Outcome
Title Change From Baseline in Rey Auditory Verbal Learning Test
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis of per-protocol (PP) cohort. Out of the 131 participants who completed the study, nine were excluded from the PP analysis (5 from the placebo group and 4 from the PS-omega3 group), one due to short interval between visits and the rest didn't meet the compliance criteria (≥ 65%).
Arm/Group Title PS-Omega3 Placebo
Hide Arm/Group Description:
Phosphatidylserine-Omega3, 300mg/day 15 wk
Cellulose tainted with fishy odor
Overall Number of Participants Analyzed 60 62
Mean (Standard Error)
Unit of Measure: number of words correctly recalled
Immediate recall 1.53  (0.26) 1.00  (0.20)
Total Learning 5.30  (0.89) 4.02  (0.85)
Delayed recall 0.93  (0.29) 0.79  (0.35)
2.Secondary Outcome
Title Blood Work
Hide Description [Not Specified]
Time Frame baseline,15 wk
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Trail Making Test
Hide Description [Not Specified]
Time Frame Baseline, 15 weeks
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Computerized Cognitive Assessment Tool
Hide Description [Not Specified]
Time Frame baseline, 15 weeks
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Clinical Global Impression of Change (CGI-C)Scale
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis of per-protocol (PP) cohort. Out of the 131 participants who completed the study, nine were excluded from the PP analysis (5 from the placebo group and 4 from the PS-omega3 group), one due to short interval between visits and the rest didn't meet the compliance criteria (≥ 65%).
Arm/Group Title PS-Omega3 Placebo
Hide Arm/Group Description:
Phosphatidylserine-Omega3, 300mg/day 15 wk
Cellulose tainted with fishy odor
Overall Number of Participants Analyzed 60 62
Measure Type: Number
Unit of Measure: Participants who experienced improvement
22 17
6.Secondary Outcome
Title Change From Baseline in Rey Osterrieth Complex Figure Test
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis of per-protocol (PP) cohort. Out of the 131 participants who completed the study, nine were excluded from the PP analysis (5 from the placebo group and 4 from the PS-omega3 group), one due to short interval between visits and the rest didn't meet the compliance criteria (≥ 65%).
Arm/Group Title PS-Omega3 Placebo
Hide Arm/Group Description:
Phosphatidylserine-Omega3, 300mg/day 15 wk
Cellulose tainted with fishy odor
Overall Number of Participants Analyzed 60 62
Mean (Standard Error)
Unit of Measure: Units on a scale
Copy Time (sec) -23.27  (8.92) 3.73  (12.44)
Immediate recall 2.73  (0.68) 1.35  (0.66)
Delayed recall 2.28  (0.68) 2.37  (0.67)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PS-Omega3 Placebo
Hide Arm/Group Description Phosphatidylserine-Omega3, 300mg/day 15 wk Cellulose tainted with fishy odor
All-Cause Mortality
PS-Omega3 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
PS-Omega3 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/79 (0.00%)   0/78 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PS-Omega3 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/79 (0.00%)   0/78 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Prof. A. Korczyn
Organization: Sourazky Tel-Aviv Medical Center
Phone: 972-3-6974229
EMail: amosk@tasmc.health.gov.il
Layout table for additonal information
Responsible Party: Yael Richter PhD, Enzymotec
ClinicalTrials.gov Identifier: NCT00437983    
Other Study ID Numbers: Memory_PS 001
First Submitted: February 20, 2007
First Posted: February 21, 2007
Results First Submitted: June 30, 2009
Results First Posted: November 25, 2009
Last Update Posted: January 5, 2010