Clinical trial: The Efficacy of Phosphatidylserine-Omega3 in Elderly With Age Associated Memory Impairment (NCT00437983)

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.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 50 Years old.
Subject must be at most 90 Years

Patient description (medical language): A 70-year-old man comes to the office accompanied by his wife.  The patient has experienced progressive memory loss over the last years.  He needs help with some of his routine activities, such as paying bills.  The patient's wife says, "He used to be such an independent person, but now he needs help with many things, even finding direction to home!"  Medical history includes hypertension, hyperlipidemia, and type 2 diabetes mellitus.  Family history includes Alzheimer disease in his father.  MRI reveals diffuse cortical and hippocampal atrophy. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria.

Patient description (patient's own words): I am a 70-year-old man, and I paid a visit to the doctor with my wife the other day. I noticed that I tend to forget small things and that my memory has decreased over the past few years. I even ask my wife to help me out with my daily routine. I used to be the one paying the bills, but now she has to give me a hand. My wife mentioned to the doctor that I used to be independent and that I tend to forget where we live. I suffer from hypertension, high cholesterol, and type 2 diabetes. My poor dad was suffering from Alzheimer disease, so I hope I'm not going to end the same way! I did an MRI and they found out that some part of my brain was decreasing. I also did an Alzheimer test.

Does the patient match the trial criteria? Contradiction