- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00719953
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
Conditions
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
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Tel-Aviv, Israel
- Suorasky Medical Center
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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:
- 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.
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
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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
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Additional Relevant MeSH Terms
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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