Study to Assess the Efficacy of Cognitex

Elderly Clinical Trial

— Cognitex001  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00719953
• Other study ID #: TASMC-08-NV-305-CTIL
• Secondary ID: 0305-08-TLV
• Status: Completed
• Phase: Phase 4
• First received: July 21, 2008
• Last updated: April 18, 2010
• Start date: August 2008
• Est. completion date: August 2009

Study information

• Verified date: July 2008
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years to 90 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Elderly
• Memory Disorders
• Memory Impairment

Intervention

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

Locations

Country	Name	City	State
Israel	Suorasky Medical Center	Tel-Aviv

Sponsors (2)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center	Enzymotec

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of Cognitive Performance (Change From Baseline in Neuropsychological Computerized Test)	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).	Base line and 12 weeks	No