Official Title: “A Single-Center, Open-label Study to Assess the Efficacy of Cognitex in Elderly Subjects With Memory Impairment”

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

Study Type: Interventional

Study Design: Treatment, Open Label, Single Group Assignment, Efficacy Study

Study Primary Completion Date: March 2009

Intervention(s) in this Clinical Trial

• Dietary Supplement: Cognitex
  • Assessing the Efficacy of Cognitex in Elderly Subjects with Memory Impairment

Primary Measures

• Improvement of Cognitive Performance (Change From Baseline in Neuropsychological Computerized Test)
  • Time Frame: 12 weeks
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 60 Years

Maximum Age for this Clinical Trial: 90 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Tel-Aviv Sourasky Medical Center

Overall Clinical Trial Officials and Contacts

Nachum Vaisman, Prof' Principal Investigator Tel-Aviv Sourasky Medical Center, Israel  

Information obtained from ClinicalTrials.gov on February 04, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00719953

Study ID Number: TASMC-08-NV-305-CTIL

ClinicalTrials.gov Identifier: NCT00719953

Health Authority: Israel: Ministry of Health