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The primary objective of this trial is to assess the ability of Phosphatidylserine-Omega3 to improve cognitive performance in elderly subjects with memory impairment.
This study is a single-center, open-label 15 weeks duration trial to assess efficacy of Phosphatidylserine-Omega3 in elderly subjects with memory impairment.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phosphatidylserine-Omega3 (SharpPS™-Gold) | Dietary Supplement | Treatment will consist of capsules containing 100 mg phosphatidylserine-Omega3. Dosage: 1 capsule X 3 times daily, with meals. Duration: 15 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Neuropsychological Computerized Test | The computerized neuropsychological assessment software consists of seven separate tasks: symbol spotting, pattern identification, pattern recall, digit-symbol substitution, digits span forward, digits span backward and delayed pattern recall. Based on the results obtained in the single tasks, eight cognitive composite scores are calculated including focused attention, sustained attention, memory recognition & recall, visuospatial learning, spatial short term memory, executive functions and mental flexibility.The total score range is from 0 to 100 points(0 is worse, 100 is best). | baseline, 15 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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) were classified as improved over the treatment period. |
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INCLUSION CRITERIA
EXCLUSION CRITERIA
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| Name | Affiliation | Role |
|---|---|---|
| Veronica Vakhapova, MD | Sourasky Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Tel Aviv Sourasky Medical Center, Neurology department | Tel Aviv | 64239 | Israel |
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Participants were recruited through advertisements in senior citizens' homes, hospitals, and newspapers.
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| ID | Title | Description |
|---|---|---|
| FG000 | PS-Omega3 | Treatment will consist of capsules containing 100 mg phosphatidylserine-Omega3. Dosage: 1 capsule X 3 times daily, with meals |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PS-Omega3 | Treatment will consist of capsules containing 100 mg phosphatidylserine-Omega3. Dosage: 1 capsule X 3 times daily, with meals |
| 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 Neuropsychological Computerized Test | The computerized neuropsychological assessment software consists of seven separate tasks: symbol spotting, pattern identification, pattern recall, digit-symbol substitution, digits span forward, digits span backward and delayed pattern recall. Based on the results obtained in the single tasks, eight cognitive composite scores are calculated including focused attention, sustained attention, memory recognition & recall, visuospatial learning, spatial short term memory, executive functions and mental flexibility.The total score range is from 0 to 100 points(0 is worse, 100 is best). | Posted | Mean | Standard Deviation | Points on a scale | baseline, 15 weeks |
|
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| 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 | Treatment will consist of capsules containing 100 mg phosphatidylserine-Omega3. Dosage: 1 capsule X 3 times daily, with meals |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| gastrointestinal disorders | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. V. Vakhapova | Sourazky Tel-Aviv Medical Center | 972-3-6973698 | vedanicek@gmail.com |
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| ID | Term |
|---|---|
| D008569 | Memory Disorders |
| ID | Term |
|---|---|
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| 15 weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
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| 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) were classified as improved over the treatment period. | Not Posted | Number | Participants who experienced improvement | 15 weeks |
| 0 |
| 18 |
| 2 |
| 18 |
| Hepatitis | General disorders | Not related |
|
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| D013568 | Pathological Conditions, Signs and Symptoms |