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

Study Overview
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Brief Summary
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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.

Official Title
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A Single-Center, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy of Phosphatidylserine-Omega3 in Elderly With Age Associated Memory Impairment

Conditions
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Age Associated Memory Impairment

Intervention / Treatment
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* Dietary Supplement: PS-Omega3
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PS-Omega3<br>Phosphatidylserine-Omega3, 300mg/day 15 wk | Dietary Supplement: PS-Omega3<br>* Phosphatidylserine-Omega3 capsules 3x100mg/day 15 wk. Next, follow up phase, open label,1x100mg/day, 15 wk<br>|
| Placebo Comparator: Placebo<br>Cellulose tainted with fishy odor, 3 capsules/day | Dietary Supplement: Placebo<br>* Placebo cellulose tainted with fishy odor capsules 3x100mg/day 15 wk<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Rey Auditory Verbal Learning Test | 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). | baseline, 15 wk | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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) | 7 weeks, 15 weeks | 
| Change From Baseline in Rey Osterrieth Complex Figure Test | 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). | baseline, 15 weeks |