The Efficacy of Phosphatidylserine-Omega3 in Elderly With Age Associated Memory Impairment

Phase 4

Completed

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

Ability to give written informed consent
Age: 90≥ years ≥50
Gender: male and female
CDR ≤ 0.5
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.
Mini-Mental State Examination (MMSE) ≥27 for subjects with college education (BA) and ≥ 26 for all others
Memory test performance that is at least 1 SD below the mean established for young adults on at least one neuropsychological subtest of NexAde.
Language: Subjects must be able to read, write and speak Hebrew.
Ability to perform tests and interviews

Exclusion Criteria

Evidence of delirium, confusion, or other disturbances of consciousness
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
History of any infective or inflammatory brain disease including those of viral, fungal, or syphilitic etiologies
Evidence of significant cerebral vascular pathology
Head injury immediately preceding cognitive deterioration.
Current psychiatric diagnosis according to DSM IV criteria of depression, mania, or any other major psychiatric disorder
Current diagnosis or history of alcoholism or drug dependence.
Evidence of depression as determined by the Geriatric Depression Scale (short version) score of 5 or more.
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
Use of psychotropic drug or any other drug or supplement that may significantly affect cognitive functioning during the month prior to psychometric testing.
Use of any experimental medication within 1 month prior to screening or as concomitant medications.
Subject has a history of hypersensitivity or allergy to fish or fish oil or soy.

Arm && Interventions

Group	Intervention	Description
PS-Omega3	PS-Omega3	Phosphatidylserine-Omega3, 300mg/day 15 wk
Placebo	Placebo	Cellulose tainted with fishy odor, 3 capsules/day

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Rey Auditory Verbal Learning Test	baseline, 15 wk	A widely used, brief, easy to understand scale to evaluate verbal learning and memory. The score is presented as the number of words correctly recalled (0 is worse, 15 is best).The total learning task score ranges from 0 to 45 words(0 is worse, 45 is best).

Secondary Outcome Measures

Name	Time	Method
Blood Work	baseline,15 wk
Trail Making Test	Baseline, 15 weeks
Computerized Cognitive Assessment Tool	baseline, 15 weeks
Clinical Global Impression of Change (CGI-C)Scale	7 weeks, 15 weeks	The Clinical Global Impression of Change (CGI-C)scale is designed to record the clinician's global impression of change. Global improvement score ranges from 1 = "Very much improved", through 4 = "No change", to 7 = "Very much worse". Participants who experienced an improvement (scores 1, 2 or 3) in at least one of the two visits (following 7 or 15 weeks of treatment) were classified as improved over the treatment period (with the exception of participants reporting improvement following 7 weeks and deterioration at endpoint, who were NOT rated as improved)
Change From Baseline in Rey Osterrieth Complex Figure Test	baseline, 15 weeks	A widely used neuropsychological tool for the evaluation of visuospatial constructional ability and visual memory. Both the time to complete the task (copy time)and the accuracy (immediate and delayed recall) were used as measures for the analysis. Accuracy range score is 0-36 points (0 is worse, 36 is best). Copy time is expressed in seconds (less time to copy indicates better performance).