Clinical trial NCT00719953: Study to Assess the Efficacy of Cognitex
Official title: A Single-Center, Open-label Study to Assess the Efficacy of Cognitex in Elderly Subjects With Memory Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Elderly
Memory Impairment
Keywords: Cognitex
subjects
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Enzymotec
First posted: 2008-07-22
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Improvement of Cognitive Performance (Change From Baseline in Neuropsychological Computerized Test)
timeFrame: Base line and 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tel-Aviv
country: Israel
facility: Suorasky Medical Center
Study officials:
affiliation: Tel-Aviv Sourasky Medical Center, Israel
name: Nachum Vaisman, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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.