Study to Assess the Efficacy of Cognitex (Cognitex001)

• ClinicalTrials.gov Identifier: NCT00719953
• Recruitment Status: Completed
• First Posted: July 22, 2008
• Results First Posted: February 4, 2010
• Last Update Posted: April 20, 2010
• Sponsor: Tel-Aviv Sourasky Medical Center
• Collaborator: Enzymotec
• Information provided by: Tel-Aviv Sourasky Medical Center

Study Description

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 30 participants
• Allocation: N/A
• 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
• Actual Primary Completion Date: March 2009
• Actual Study Completion Date: August 2009

Arms and Interventions

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

Outcome Measures

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).

Eligibility Criteria

• Ages Eligible for Study: 60 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Richter Y, Herzog Y, Eyal I, Cohen T. Cognitex supplementation in elderly adults with memory complaints: an uncontrolled open label trial. J Diet Suppl. 2011 Jun;8(2):158-68. doi: 10.3109/19390211.2011.569514.

• Responsible Party: Yael Richter. Project Manager, Enzymotec Ltd.
• ClinicalTrials.gov Identifier: NCT00719953
• Other Study ID Numbers: TASMC-08-NV-305-CTIL; 0305-08-TLV
• First Posted: July 22, 2008
• Results First Posted: February 4, 2010
• Last Update Posted: April 20, 2010
• Last Verified: July 2008

Keywords provided by Tel-Aviv Sourasky Medical Center:

Cognitex; subjects

Additional relevant MeSH terms:

Memory Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases