Study to Assess the Efficacy of Cognitex

Phase 4

Completed

• Conditions: Elderly; Memory Impairment

• Registration Number: NCT00719953
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2008-07
• Study First Submitted: 2008-07-21
• Study First Submitted QC: 2008-07-21
• Study First Posted: 2008-07-22
• Study Start: 2008-08
• Primary Completion: 2009-03
• Study Completion: 2009-08
• Results First Submitted: 2010-01-10
• Results First Submitted QC: 2010-01-10
• Results First Posted: 2010-02-04
• Last Update Submitted: 2010-04-18
• Last Update Posted: 2010-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Improvement of Cognitive Performance (Change From Baseline in Neuropsychological Computerized Test)	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).

Trial Locations

Locations (1)

Suorasky Medical Center; 🇮🇱 Tel-Aviv, Israel