Study to Assess the Efficacy of Cognitex

NCT ID: NCT00719953

Last Updated: 2010-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2009-08-31

Brief Summary

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

Conditions

Elderly; Memory Impairment

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Enzymotec

INDUSTRY

Sponsor Role: collaborator

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Enzymotec Ltd.

Principal Investigators

Nachum Vaisman, Professor

Role: PRINCIPAL_INVESTIGATOR

Tel-Aviv Sourasky Medical Center, Israel

Locations

Suorasky Medical Center

Tel Aviv, , Israel

Countries

Israel

References

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.

Reference Type: DERIVED

PMID: 22432687 (View on PubMed)

Other Identifiers

0305-08-TLV

Identifier Type: -

Identifier Source: secondary_id

TASMC-08-NV-305-CTIL

Identifier Type: -

Identifier Source: org_study_id