Study to Assess the Efficacy of Cognitex (Cognitex001)
This study has been completed.
Sponsor:
Tel-Aviv Sourasky Medical Center
Collaborator:
Enzymotec
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT00719953
First received: July 21, 2008
Last updated: April 18, 2010
Last verified: July 2008
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Purpose
A Single-Center, Open Label Study to Assess the Efficacy of Cognitex in Elderly Subjects with Memory Impairment
| Condition | Intervention | Phase |
|---|---|---|
|
Elderly Memory Impairment |
Dietary Supplement: Cognitex |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Single-Center, Open-label Study to Assess the Efficacy of Cognitex in Elderly Subjects With Memory Impairment |
Resource links provided by NLM:
Further study details as provided by Tel-Aviv Sourasky Medical Center:
Primary Outcome Measures:
- Improvement of Cognitive Performance (Change From Baseline in Neuropsychological Computerized Test) [ Time Frame: Base line and 12 weeks ] [ Designated as safety issue: No ]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).
| Enrollment: | 30 |
| Study Start Date: | August 2008 |
| Study Completion Date: | August 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Dietary Supplement: 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
Eligibility| Ages Eligible for Study: | 60 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Ability to give written informed consent.
- Age: 90≥ years ≥60.
- Gender: male and female.
- Memory test performance within or below the mean established for adults in the computerized cognitive tool, with a maximum of four neuropsychological subtests scored 1.5 SD above the mean.
- Language: Subjects must be able to read, write and speak Hebrew.
- Ability to perform tests and interviews.
Exclusion Criteria:
- Evidence of delirium, confusion, or other disturbances of consciousness.
- Evidence of dementia.
- Any Neurological disorder that could produce cognitive deterioration. Such disorders include Parkinson's disease, stroke, intracranial hemorrhage, local brain lesions including tumors and normal pressure hydrocephalus.
- History of any infective or inflammatory brain disease including those of viral, fungal, or syphilitic etiologies.
- Head injury immediately preceding cognitive deterioration.
- Evidence of depression as determined by a the Geriatric Depression Scale (short version) score of 5 or more.
- Current diagnosis or history of alcoholism or drug dependence.
- Any medical disorder that could produce cognitive deterioration including renal, respiratory, cardiac, and hepatic disease, diabetes mellitus, endocrine, metabolic or hematological disturbances unless well controlled, and malignancy not in remission for more than two years
- Use of anti-clotting or antiplatelet medications or supplements for less than two years.
- History of clotting or platelet disorder unless well controlled.
- Use of any supplement that may significantly affect cognitive functioning during the month prior to study initiation.
- Use of any experimental medication within 1 month prior to screening or as concomitant medications.
- History of hypersensitivity or allergy to soy or fish.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00719953
Locations
| Israel | |
| Suorasky Medical Center | |
| Tel-Aviv, Israel | |
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Enzymotec
Investigators
| Principal Investigator: | Nachum Vaisman, Professor | Tel-Aviv Sourasky Medical Center, Israel |
More Information
No publications provided by Tel-Aviv Sourasky Medical Center
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Yael Richter. Project Manager, Enzymotec Ltd. |
| ClinicalTrials.gov Identifier: | NCT00719953 History of Changes |
| Other Study ID Numbers: | TASMC-08-NV-305-CTIL, 0305-08-TLV |
| Study First Received: | July 21, 2008 |
| Results First Received: | January 10, 2010 |
| Last Updated: | April 18, 2010 |
| Health Authority: | Israel: Ministry of Health |
Keywords provided by Tel-Aviv Sourasky Medical Center:
|
Cognitex subjects |
Additional relevant MeSH terms:
|
Memory Disorders Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013