The Efficacy of Phosphatidylserine-Omega3 in Elderly Subjects With Memory Impairment
Condition: Memory Impairment
MeSH terms: Memory Disorders
Intervention: Phosphatidylserine-Omega3 (SharpPS™-Gold)
Intervention description: Treatment will consist of capsules containing 100 mg phosphatidylserine-Omega3. Dosage: 1 capsule X 3 times daily, with meals. Duration: 15 weeks
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 65 Years
Maximum age: 90 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Age Associated Memory Impairment

Summary:

      The primary objective of this trial is to assess the ability of Phosphatidylserine-Omega3 to
      improve cognitive performance in elderly subjects with memory impairment.

      This study is a single-center, open-label 15 weeks duration trial to assess efficacy of
      Phosphatidylserine-Omega3 in elderly subjects with memory impairment.
    

Eligibility criteria:

        INCLUSION CRITERIA

          1. Ability to give written informed consent

          2. Age: 90≥ years ≥65

          3. Gender: male and female.

          4. Clinical Dementia Rating Scale (CDR) ≤ 0.5

          5. Mini-Mental State Examination (MMSE) ≥ 26

          6. Memory test performance within or below the mean established for adults, with maximum
             of four neuropsychological subtests of the computerized test scored as 1.5 SD above
             the mean

          7. Language: Subjects must be able to read, write and speak Hebrew.

          8. Ability to perform tests and interviews.

        EXCLUSION CRITERIA

          1. Evidence of delirium, confusion, or other disturbances of consciousness.

          2. Any Neurological disorder that could produce cognitive deterioration. Such disorders
             include AD, Parkinson's disease, stroke, intracranial hemorrhage, local brain lesions
             including tumors, and normal pressure hydrocephalus

          3. History of any infective or inflammatory brain disease including those of viral,
             fungal, or syphilitic etiologies.

          4. Head injury immediately preceding cognitive deterioration.

          5. Current psychiatric diagnosis according to DSM IV criteria of depression, mania, or
             any other major psychiatric disorder, or evidence of depression as determined by the
             Geriatric Depression Scale (GDS15) score of 5 or more.

          6. Current diagnosis or history of alcoholism or drug dependence.

          7. 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.

          8. Use of psychotropic drug or any other drug or supplement that may significantly affect
             cognitive functioning during the month prior to psychometric testing.

          9. Use of any experimental medication within 1 month prior to screening or as concomitant
             medications.

         10. History of hypersensitivity or allergy to fish or fish oil.