The Efficacy of Phosphatidylserine-Omega3 in Elderly Subjects With Memory Impairment

Phase 4

Completed

• Conditions: Memory Impairment

• Registration Number: NCT00736034
• Lead Sponsor: Enzymotec

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-08-14
• Study First Submitted QC: 2008-08-14
• Study First Posted: 2008-08-15
• Study Start: 2008-09
• Primary Completion: 2009-03
• Status Verified: 2009-04
• Study Completion: 2009-04
• Results First Submitted: 2010-03-04
• Results First Submitted QC: 2010-03-04
• Results First Posted: 2010-03-24
• Last Update Submitted: 2010-03-26
• Last Update Posted: 2010-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Neuropsychological Computerized Test	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).

Secondary Outcome Measures

Name	Time	Method
Clinical Global Impression of Change (CGI-C)Scale	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.

Trial Locations

Locations (1)

The Tel Aviv Sourasky Medical Center, Neurology department; 🇮🇱 Tel Aviv, Israel