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| ID | Type | Description | Link |
|---|---|---|---|
| 0305-08-TLV |
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| Name | Class |
|---|---|
| Enzymotec | INDUSTRY |
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A Single-Center, Open Label Study to Assess the Efficacy of Cognitex in Elderly Subjects with Memory Impairment
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitex | Dietary Supplement | Treatment will consist of one capsule of Cognitex (Life Extension, USA), three times a day, with meals, delivering a total of 600 mg GPC, 100 mg PS-omega 3, 20 mg vinpocetine, 50 mg uridine-5'-monophosphate (disodium), 550 mg plant extracts (150 mg wild blueberry, 125 mg ashwagandha, 150 mg grape seed, 125 mg hops, ginger and rosemary). Duration: 15 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of Cognitive Performance (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). | Base line and 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nachum Vaisman, Professor | Tel-Aviv Sourasky Medical Center, Israel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Suorasky Medical Center | Tel Aviv | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22432687 | Derived | Richter Y, Herzog Y, Eyal I, Cohen T. Cognitex supplementation in elderly adults with memory complaints: an uncontrolled open label trial. J Diet Suppl. 2011 Jun;8(2):158-68. doi: 10.3109/19390211.2011.569514. |
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Participants were recruited through advertisements in senior citizens' homes, hospitals, and newspapers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cognitex | Treatment will consist of one capsule of Cognitex (Life Extension, USA), three times a day, with meals, delivering a total of 600 mg GPC, 100 mg PS-omega 3, 20 mg vinpocetine, 50 mg uridine-5'-monophosphate (disodium), 550 mg plant extracts (150 mg wild blueberry, 125 mg ashwagandha, 150 mg grape seed, 125 mg hops, ginger and rosemary). Duration: 15 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cognitex | Treatment will consist of one capsule of Cognitex (Life Extension, USA), three times a day, with meals, delivering a total of 600 mg GPC, 100 mg PS-omega 3, 20 mg vinpocetine, 50 mg uridine-5'-monophosphate (disodium), 550 mg plant extracts (150 mg wild blueberry, 125 mg ashwagandha, 150 mg grape seed, 125 mg hops, ginger and rosemary). Duration: 15 weeks |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Improvement of Cognitive Performance (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 Error | Points on a scale | Base line and 12 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 | Cognitex | Treatment will consist of one capsule of Cognitex (Life Extension, USA), three times a day, with meals, delivering a total of 600 mg GPC, 100 mg PS-omega 3, 20 mg vinpocetine, 50 mg uridine-5'-monophosphate (disodium), 550 mg plant extracts (150 mg wild blueberry, 125 mg ashwagandha, 150 mg grape seed, 125 mg hops, ginger and rosemary). Duration: 15 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dirarrhea | Gastrointestinal disorders | Two patients were affected, only one event was defined as probably related. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor N. Vaisman | Sourazky Tel-Aviv Medical Center | 972-3-6974807 | vaisman@tasmc.health.gov.il |
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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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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 0 |
| 30 |
| 5 |
| 30 |
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| Hypertension | Vascular disorders | Three patients were affected, two of them had a history of hypertension, and theirs events were defined as not related. |
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| D013568 | Pathological Conditions, Signs and Symptoms |