Back to results

Study to Assess the Efficacy of Cognitex (Cognitex001)

Primary Purpose

Elderly, Memory Impairment

Status

Completed

Phase

Phase 4

Locations

Israel

Study Type

Interventional

Intervention

Cognitex

About this trial

This is an interventional treatment trial for Elderly focused on measuring Cognitex, subjects

Eligibility Criteria

60 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Ability to give written informed consent.
Age: 90≥ years ≥60.
Gender: male and female.
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.
Language: Subjects must be able to read, write and speak Hebrew.
Ability to perform tests and interviews.

Exclusion Criteria:

Evidence of delirium, confusion, or other disturbances of consciousness.
Evidence of dementia.
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.
History of any infective or inflammatory brain disease including those of viral, fungal, or syphilitic etiologies.
Head injury immediately preceding cognitive deterioration.
Evidence of depression as determined by a the Geriatric Depression Scale (short version) score of 5 or more.
Current diagnosis or history of alcoholism or drug dependence.
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
Use of anti-clotting or antiplatelet medications or supplements for less than two years.
History of clotting or platelet disorder unless well controlled.
Use of any supplement that may significantly affect cognitive functioning during the month prior to study initiation.
Use of any experimental medication within 1 month prior to screening or as concomitant medications.
History of hypersensitivity or allergy to soy or fish.

Sites / Locations

Suorasky Medical Center

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

NCT ID

NCT00719953

First Posted

July 21, 2008

Last Updated

April 18, 2010

Sponsor

Tel-Aviv Sourasky Medical Center

Collaborators

Enzymotec

1. Study Identification

Unique Protocol Identification Number

NCT00719953

Brief Title

Study to Assess the Efficacy of Cognitex

Acronym

Cognitex001

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2008

Overall Recruitment Status

Completed

Study Start Date

August 2008 (undefined)

Primary Completion Date

March 2009 (Actual)

Study Completion Date

August 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Tel-Aviv Sourasky Medical Center

Collaborators

Enzymotec

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Elderly, Memory Impairment

Keywords

Cognitex, subjects

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Dietary Supplement

Intervention Name(s)

Cognitex

Intervention Description

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

Primary Outcome Measure Information:

Title

Improvement of Cognitive Performance (Change From Baseline in Neuropsychological Computerized Test)

Description

Time Frame

Base line and 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Ability to give written informed consent. Age: 90≥ years ≥60. Gender: male and female. 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. Language: Subjects must be able to read, write and speak Hebrew. Ability to perform tests and interviews. Exclusion Criteria: Evidence of delirium, confusion, or other disturbances of consciousness. Evidence of dementia. 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. History of any infective or inflammatory brain disease including those of viral, fungal, or syphilitic etiologies. Head injury immediately preceding cognitive deterioration. Evidence of depression as determined by a the Geriatric Depression Scale (short version) score of 5 or more. Current diagnosis or history of alcoholism or drug dependence. 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 Use of anti-clotting or antiplatelet medications or supplements for less than two years. History of clotting or platelet disorder unless well controlled. Use of any supplement that may significantly affect cognitive functioning during the month prior to study initiation. Use of any experimental medication within 1 month prior to screening or as concomitant medications. History of hypersensitivity or allergy to soy or fish.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nachum Vaisman, Professor

Organizational Affiliation

Tel-Aviv Sourasky Medical Center, Israel

Official's Role

Principal Investigator

Facility Information:

Facility Name

Suorasky Medical Center

City

Tel-Aviv

Country

Israel

12. IPD Sharing Statement

Citations:

PubMed Identifier

22432687

Citation

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.

Results Reference

derived

Learn more about this trial

Study to Assess the Efficacy of Cognitex

We'll reach out to this number within 24 hrs