Study to Assess the Efficacy of Cognitex (Cognitex001)

April 18, 2010 updated by: Tel-Aviv Sourasky Medical Center

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

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

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Tel-Aviv, Israel
        • Suorasky Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Base line and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Nachum Vaisman, Professor, Tel-Aviv Sourasky Medical Center, Israel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

July 21, 2008

First Submitted That Met QC Criteria

July 21, 2008

First Posted (Estimate)

July 22, 2008

Study Record Updates

Last Update Posted (Estimate)

April 20, 2010

Last Update Submitted That Met QC Criteria

April 18, 2010

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TASMC-08-NV-305-CTIL
  • 0305-08-TLV

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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