The Efficacy of Phosphatidylserine-Omega3 in Elderly With Age Associated Memory Impairment
Condition: Age Associated Memory Impairment
MeSH terms: Memory Disorders
Intervention: PS-Omega3; Placebo
Intervention description: Phosphatidylserine-Omega3 capsules 3x100mg/day 15 wk. Next, follow up phase, open label,1x100mg/day, 15 wk; Placebo cellulose tainted with fishy odor capsules 3x100mg/day 15 wk
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 157.0
Sex: All
Minimum age: 50 Years
Maximum age: 90 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective of this trial is to assess the ability of an oral administration of
      Phosphatidylserine-Omega3 to improve attention and memory complaints in comparison to placebo
      in age associated memory impaired subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Ability to give written informed consent

          2. Age: 90≥ years ≥50

          3. Gender: male and female

          4. CDR ≤ 0.5

          5. Complaints of memory loss reflected in such everyday problems as difficulty
             remembering names of individuals following introduction, misplacing objects,
             difficulty remembering multiple items to be purchased or multiple tasks to be
             performed, difficulty remembering telephone numbers or zip codes, and difficulty
             recalling information quickly or following distraction. Onset of memory loss must be
             described as gradual, without sudden worsening in recent months. Complaints of memory
             loss to be assessed by the MAC-Q scale.

          6. Mini-Mental State Examination (MMSE) ≥27 for subjects with college education (BA) and
             ≥ 26 for all others

          7. Memory test performance that is at least 1 SD below the mean established for young
             adults on at least one neuropsychological subtest of NexAde.

          8. Language: Subjects must be able to read, write and speak Hebrew.

          9. 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. Evidence of significant cerebral vascular pathology

          5. Head injury immediately preceding cognitive deterioration.

          6. Current psychiatric diagnosis according to DSM IV criteria of depression, mania, or
             any other major psychiatric disorder

          7. Current diagnosis or history of alcoholism or drug dependence.

          8. Evidence of depression as determined by the Geriatric Depression Scale (short version)
             score of 5 or more.

          9. 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

         10. Use of psychotropic drug or any other drug or supplement that may significantly affect
             cognitive functioning during the month prior to psychometric testing.

         11. Use of any experimental medication within 1 month prior to screening or as concomitant
             medications.

         12. Subject has a history of hypersensitivity or allergy to fish or fish oil or soy.