Study to Assess the Efficacy of Cognitex (Cognitex001)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00719953
Recruitment Status : Completed
First Posted : July 22, 2008
Results First Posted : February 4, 2010
Last Update Posted : April 20, 2010
Information provided by:
Tel-Aviv Sourasky Medical Center

Brief Summary:
A Single-Center, Open Label Study to Assess the Efficacy of Cognitex in Elderly Subjects with Memory Impairment

Condition or disease Intervention/treatment Phase
Elderly Memory Impairment Dietary Supplement: Cognitex Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : August 2008
Primary Completion Date : March 2009
Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Improvement of Cognitive Performance (Change From Baseline in Neuropsychological Computerized Test) [ Time Frame: Base line and 12 weeks ]
    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).

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Ages Eligible for Study:   60 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Ability to give written informed consent.
  2. Age: 90≥ years ≥60.
  3. Gender: male and female.
  4. 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.
  5. Language: Subjects must be able to read, write and speak Hebrew.
  6. Ability to perform tests and interviews.

Exclusion Criteria:

  1. Evidence of delirium, confusion, or other disturbances of consciousness.
  2. Evidence of dementia.
  3. 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.
  4. History of any infective or inflammatory brain disease including those of viral, fungal, or syphilitic etiologies.
  5. Head injury immediately preceding cognitive deterioration.
  6. Evidence of depression as determined by a the Geriatric Depression Scale (short version) score of 5 or more.
  7. Current diagnosis or history of alcoholism or drug dependence.
  8. 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
  9. Use of anti-clotting or antiplatelet medications or supplements for less than two years.
  10. History of clotting or platelet disorder unless well controlled.
  11. Use of any supplement that may significantly affect cognitive functioning during the month prior to study initiation.
  12. Use of any experimental medication within 1 month prior to screening or as concomitant medications.
  13. History of hypersensitivity or allergy to soy or fish.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00719953

Suorasky Medical Center
Tel-Aviv, Israel
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Principal Investigator: Nachum Vaisman, Professor Tel-Aviv Sourasky Medical Center, Israel

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Yael Richter. Project Manager, Enzymotec Ltd. Identifier: NCT00719953     History of Changes
Other Study ID Numbers: TASMC-08-NV-305-CTIL
First Posted: July 22, 2008    Key Record Dates
Results First Posted: February 4, 2010
Last Update Posted: April 20, 2010
Last Verified: July 2008

Keywords provided by Tel-Aviv Sourasky Medical Center:

Additional relevant MeSH terms:
Memory Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms