Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PS-Omega3 | Active Comparator | Phosphatidylserine-Omega3, 300mg/day 15 wk |
|
| Placebo | Placebo Comparator | Cellulose tainted with fishy odor, 3 capsules/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PS-Omega3 | Dietary Supplement | Phosphatidylserine-Omega3 capsules 3x100mg/day 15 wk. Next, follow up phase, open label,1x100mg/day, 15 wk |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | baseline, 15 wk |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Work | baseline,15 wk | |
| Trail Making Test | Baseline, 15 weeks | |
| Computerized Cognitive Assessment Tool |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Amos Korczyn, MD | Sourasky Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Tel Aviv Sourasky Medical Center, Neurology department | Tel Aviv | 64239 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21711517 | Derived | 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. |
Not provided
Not provided
Not provided
Participants were recruited through advertisements in senior citizens' homes, hospitals, and newspapers.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | PS-Omega3 | Phosphatidylserine-Omega3, 300mg/day 15 wk |
| FG001 | Placebo | Cellulose tainted with fishy odor |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PS-Omega3 | Phosphatidylserine-Omega3, 300mg/day 15 wk |
| BG001 | Placebo | Cellulose tainted with fishy odor |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | 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%). | Posted | Mean | Standard Error | number of words correctly recalled | baseline, 15 wk |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PS-Omega3 | Phosphatidylserine-Omega3, 300mg/day 15 wk |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. A. Korczyn | Sourazky Tel-Aviv Medical Center | 972-3-6974229 | amosk@tasmc.health.gov.il |
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Dietary Supplement | Placebo cellulose tainted with fishy odor capsules 3x100mg/day 15 wk |
|
| baseline, 15 weeks |
| 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) | 7 weeks, 15 weeks |
| 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). | baseline, 15 weeks |
| Withdrawal by Subject |
|
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Placebo |
Cellulose tainted with fishy odor |
|
|
| Secondary | Blood Work | Not Posted | baseline,15 wk |
| Secondary | Trail Making Test | Not Posted | Baseline, 15 weeks |
| Secondary | Computerized Cognitive Assessment Tool | Not Posted | baseline, 15 weeks |
| Secondary | 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) | 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%). | Posted | Number | Participants who experienced improvement | 7 weeks, 15 weeks |
|
|
|
| Secondary | 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). | 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%). | Posted | Mean | Standard Error | Units on a scale | baseline, 15 weeks |
|
|
|
| 0 |
| 79 |
| 0 |
| 79 |
| EG001 | Placebo | Cellulose tainted with fishy odor | 0 | 78 | 0 | 78 |
Not provided
Not provided
| Delayed recall |
|