Study to Assess the Efficacy of Cognitex (Cognitex001)

Tel Aviv Sourasky Medical Center

Status and phase: Completed; Phase 4

Conditions: Elderly; Memory Impairment

Treatments: Dietary Supplement: Cognitex

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00719953

TASMC-08-NV-305-CTIL

0305-08-TLV

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 60 to 90 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)