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Sponsored by: |
Enzymotec |
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Information provided by: | Enzymotec |
ClinicalTrials.gov Identifier: | NCT00437983 |
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.
Condition | Intervention | Phase |
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Age Associated Memory Impairment |
Dietary Supplement: Phosphatidylserine-Omega3 Dietary Supplement: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Single-Center, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy of Phosphatidylserine-Omega3 in Elderly With Age Associated Memory Impairment |
Enrollment: | 157 |
Study Start Date: | April 2007 |
Study Completion Date: | September 2008 |
Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Phosphatidylserine-Omega3, 300mg/day 15 wk
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Dietary Supplement: Phosphatidylserine-Omega3
Phosphatidylserine-Omega3 capsules 3x100mg/day 15 wk. Next, follow up phase, open label,1x100mg/day, 15 wk
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2: Placebo Comparator
Placebo cellulose tainted with fishy odor
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Dietary Supplement: Placebo
Placebo cellulose tainted with fishy odor capsules 3x100mg/day 15 wk
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Ages Eligible for Study: | 50 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Enzymotec ( Yael Richter PhD ) |
Study ID Numbers: | Memory_PS 001 |
Study First Received: | February 20, 2007 |
Last Updated: | April 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00437983 History of Changes |
Health Authority: | Israel: Ministry of Health |
Signs and Symptoms Neurologic Manifestations Neurobehavioral Manifestations Memory Disorders |
Signs and Symptoms Nervous System Diseases Neurologic Manifestations Neurobehavioral Manifestations Memory Disorders |