The Efficacy of Phosphatidylserine-Omega3 in Elderly With Age Associated Memory Impairment
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00437983 |
|
Recruitment Status :
Completed
First Posted : February 21, 2007
Results First Posted : November 25, 2009
Last Update Posted : January 5, 2010
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Age Associated Memory Impairment | Dietary Supplement: PS-Omega3 Dietary Supplement: Placebo | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 157 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 |
| Study Start Date : | April 2007 |
| Actual Primary Completion Date : | June 2008 |
| Actual Study Completion Date : | September 2008 |
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: PS-Omega3
Phosphatidylserine-Omega3, 300mg/day 15 wk
|
Dietary Supplement: PS-Omega3
Phosphatidylserine-Omega3 capsules 3x100mg/day 15 wk. Next, follow up phase, open label,1x100mg/day, 15 wk |
|
Placebo Comparator: Placebo
Cellulose tainted with fishy odor, 3 capsules/day
|
Dietary Supplement: Placebo
Placebo cellulose tainted with fishy odor capsules 3x100mg/day 15 wk |
- Change From Baseline in Rey Auditory Verbal Learning Test [ Time Frame: baseline, 15 wk ]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).
- 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 [ Time Frame: 7 weeks, 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) 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)
- Change From Baseline in Rey Osterrieth Complex Figure Test [ Time Frame: baseline, 15 weeks ]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).
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 50 Years to 90 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00437983
| Israel | |
| The Tel Aviv Sourasky Medical Center, Neurology department | |
| Tel Aviv, Israel, 64239 | |
| Study Director: | Amos Korczyn, MD | Sourasky Medical Center |
| Responsible Party: | Yael Richter PhD, Enzymotec |
| ClinicalTrials.gov Identifier: | NCT00437983 |
| Other Study ID Numbers: |
Memory_PS 001 |
| First Posted: | February 21, 2007 Key Record Dates |
| Results First Posted: | November 25, 2009 |
| Last Update Posted: | January 5, 2010 |
| Last Verified: | January 2010 |
|
Memory Disorders Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases |

