Trial Outcomes & Findings for The Efficacy of Phosphatidylserine-Omega3 in Elderly With Age Associated Memory Impairment (NCT NCT00437983)
NCT ID: NCT00437983
Last Updated: 2010-01-05
Results Overview
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).
COMPLETED
PHASE4
157 participants
baseline, 15 wk
2010-01-05
Participant Flow
Participants were recruited through advertisements in senior citizens' homes, hospitals, and newspapers.
Participant milestones
| Measure |
PS-Omega3
Phosphatidylserine-Omega3, 300mg/day 15 wk
|
Placebo
Cellulose tainted with fishy odor
|
|---|---|---|
|
Overall Study
STARTED
|
79
|
78
|
|
Overall Study
COMPLETED
|
66
|
65
|
|
Overall Study
NOT COMPLETED
|
13
|
13
|
Reasons for withdrawal
| Measure |
PS-Omega3
Phosphatidylserine-Omega3, 300mg/day 15 wk
|
Placebo
Cellulose tainted with fishy odor
|
|---|---|---|
|
Overall Study
Adverse Event
|
6
|
6
|
|
Overall Study
Protocol Violation
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
6
|
Baseline Characteristics
The Efficacy of Phosphatidylserine-Omega3 in Elderly With Age Associated Memory Impairment
Baseline characteristics by cohort
| Measure |
PS-Omega3
n=79 Participants
Phosphatidylserine-Omega3, 300mg/day 15 wk
|
Placebo
n=78 Participants
Cellulose tainted with fishy odor
|
Total
n=157 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
72.58 years
STANDARD_DEVIATION 8.12 • n=99 Participants
|
72.46 years
STANDARD_DEVIATION 8.33 • n=107 Participants
|
72.52 years
STANDARD_DEVIATION 8.20 • n=206 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
78 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
79 Participants
n=206 Participants
|
|
Region of Enrollment
Israel
|
79 participants
n=99 Participants
|
78 participants
n=107 Participants
|
157 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: baseline, 15 wkPopulation: 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%).
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).
Outcome measures
| Measure |
PS-Omega3
n=60 Participants
Phosphatidylserine-Omega3, 300mg/day 15 wk
|
Placebo
n=62 Participants
Cellulose tainted with fishy odor
|
|---|---|---|
|
Change From Baseline in Rey Auditory Verbal Learning Test
Immediate recall
|
1.53 number of words correctly recalled
Standard Error 0.26
|
1.00 number of words correctly recalled
Standard Error 0.20
|
|
Change From Baseline in Rey Auditory Verbal Learning Test
Delayed recall
|
0.93 number of words correctly recalled
Standard Error 0.29
|
0.79 number of words correctly recalled
Standard Error 0.35
|
|
Change From Baseline in Rey Auditory Verbal Learning Test
Total Learning
|
5.30 number of words correctly recalled
Standard Error 0.89
|
4.02 number of words correctly recalled
Standard Error 0.85
|
SECONDARY outcome
Timeframe: baseline,15 wkOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 15 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, 15 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 7 weeks, 15 weeksPopulation: 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%).
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)
Outcome measures
| Measure |
PS-Omega3
n=60 Participants
Phosphatidylserine-Omega3, 300mg/day 15 wk
|
Placebo
n=62 Participants
Cellulose tainted with fishy odor
|
|---|---|---|
|
Clinical Global Impression of Change (CGI-C)Scale
|
22 Participants who experienced improvement
|
17 Participants who experienced improvement
|
SECONDARY outcome
Timeframe: baseline, 15 weeksPopulation: 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%).
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).
Outcome measures
| Measure |
PS-Omega3
n=60 Participants
Phosphatidylserine-Omega3, 300mg/day 15 wk
|
Placebo
n=62 Participants
Cellulose tainted with fishy odor
|
|---|---|---|
|
Change From Baseline in Rey Osterrieth Complex Figure Test
Copy Time (sec)
|
-23.27 Units on a scale
Standard Error 8.92
|
3.73 Units on a scale
Standard Error 12.44
|
|
Change From Baseline in Rey Osterrieth Complex Figure Test
Immediate recall
|
2.73 Units on a scale
Standard Error 0.68
|
1.35 Units on a scale
Standard Error 0.66
|
|
Change From Baseline in Rey Osterrieth Complex Figure Test
Delayed recall
|
2.28 Units on a scale
Standard Error 0.68
|
2.37 Units on a scale
Standard Error 0.67
|
Adverse Events
PS-Omega3
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place