Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Study to Assess the Efficacy of Cognitex (Cognitex001)
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Tel-Aviv Sourasky Medical Center
Enzymotec
Information provided by: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT00719953
  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 IV

MedlinePlus related topics: Memory
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment, Efficacy Study
Official Title: A Single-Center, Open-Label Study to Assess the Efficacy of Cognitex in Elderly Subjects With Memory Impairment

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • improvement of Cognitive performance [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: August 2008
Estimated Study Completion Date: August 2009
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Dietary Supplement: Cognitex
    Assessing the Efficacy of Cognitex in Elderly Subjects with Memory Impairment
  Eligibility

Ages Eligible for Study:   60 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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, Prof' Tel-Aviv Sourasky Medical Center, Israel
  More Information

Responsible Party: Enzymotec Ltd. ( Yael Richter. Project Manager )
Study ID Numbers: TASMC-08-NV-305-CTIL, 0305-08-TLV
Study First Received: July 21, 2008
Last Updated: December 18, 2008
ClinicalTrials.gov Identifier: NCT00719953  
Health Authority: Israel: Ministry of Health

Keywords provided by Tel-Aviv Sourasky Medical Center:
Cognitex
subjects

Study placed in the following topic categories:
Signs and Symptoms
Neurologic Manifestations
Neurobehavioral Manifestations
Memory Disorders

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on January 13, 2009