The Efficacy of Phosphatidylserine-Omega3 in Elderly Subjects With Memory Impairment
The primary objective of this trial is to assess the ability of Phosphatidylserine-Omega3 to improve cognitive performance in elderly subjects with memory impairment.
This study is a single-center, open-label 15 weeks duration trial to assess efficacy of Phosphatidylserine-Omega3 in elderly subjects with memory impairment.
|Memory Impairment||Dietary Supplement: Phosphatidylserine-Omega3 (SharpPS™-Gold)||Phase 4|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Single-Center, Open-Label Study to Assess the Efficacy of SharpPS™-Gold in Elderly Subjects With Memory Impairment|
- Change From Baseline in Neuropsychological Computerized Test [ Time Frame: baseline, 15 weeks ]The computerized neuropsychological assessment software consists of seven separate tasks: symbol spotting, pattern identification, pattern recall, digit-symbol substitution, digits span forward, digits span backward and delayed pattern recall. Based on the results obtained in the single tasks, eight cognitive composite scores are calculated including focused attention, sustained attention, memory recognition & recall, visuospatial learning, spatial short term memory, executive functions and mental flexibility.The total score range is from 0 to 100 points(0 is worse, 100 is best).
- Clinical Global Impression of Change (CGI-C)Scale [ Time Frame: 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) were classified as improved over the treatment period.
|Study Start Date:||September 2008|
|Study Completion Date:||April 2009|
|Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
Dietary Supplement: Phosphatidylserine-Omega3 (SharpPS™-Gold)
Please refer to this study by its ClinicalTrials.gov identifier: NCT00736034
|The Tel Aviv Sourasky Medical Center, Neurology department|
|Tel Aviv, Israel, 64239|
|Principal Investigator:||Veronica Vakhapova, MD||Sourasky Medical Center|