Study to Assess the Efficacy of Cognitex (Cognitex001)

This study has been completed.
Sponsor:
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
  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:

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 01, 2014