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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
157
The Tel Aviv Sourasky Medical Center, Neurology department
Tel Aviv, Israel
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).
Time frame: baseline, 15 wk
Blood Work
Time frame: baseline,15 wk
Trail Making Test
Time frame: Baseline, 15 weeks
Computerized Cognitive Assessment Tool
Time frame: 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)
Time frame: 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).
Time frame: baseline, 15 weeks
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