Study to Assess the Efficacy of Cognitex
Condition: Elderly; Memory Impairment
MeSH terms: Memory Disorders
Intervention: Cognitex
Intervention description: Treatment will consist of one capsule of Cognitex (Life Extension, USA), three times a day, with meals, delivering a total of 600 mg GPC, 100 mg PS-omega 3, 20 mg vinpocetine, 50 mg uridine-5'-monophosphate (disodium), 550 mg plant extracts (150 mg wild blueberry, 125 mg ashwagandha, 150 mg grape seed, 125 mg hops, ginger and rosemary). Duration: 15 weeks
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 60 Years
Maximum age: 90 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Cognitex; subjects

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.