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Due to difficulties in patient recruitment
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The primary objective is to evaluate the efficacy and safety of phosphatidylserine (PS) on cognitive abilities in MCI
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Identical looking cellulose capsules |
|
| Phosphatidylserine | Experimental | Phosphatidylserine-omega-3, DHA enriched |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phosphatidylserine | Other |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in change in the Selective Reminding Test (SRT) between the study groups. | baseline, 3, 6,12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mini Mental State Examination (MMSE) | baseline, 12 and 24 months | |
| Computerized Neurological battery test (NBT) | baseline, 6, 12 and 24 months | |
| Transition rate to dementia according to DSM-4 criteria |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of phosphatidylserine versus placebo treatment | Clinical laboratory safety data will be collected at baseline and 24 months. Vital signs will be measured at baseline, 12 and 24 months. Adverse events (including changes to concomitant medications) will be documented at all study visits (i.e baseline, 3, 6, 12, 18 and 24 months). | baseline, 3, 6, 12, 18 and 24 months |
Inclusion Criteria:
Age greater than or equal to 65 and less than or equal to 85 years.
Formal education greater than or equal to 10 years.
Male or female with a diagnosis of Mild Cognitive Impairment (MCI) 3. Male or female with a diagnosis of Mild Cognitive Impairment (MCI) as defined by Peterson, according to The following:
3.1 Clinical Dementia Rating Scale total score (CDR) ≤0.5, and score of each one of the six categories ("box scores") ≤ 1. 3.2 Mini Mental State Exam > 24 3.3 Verbal Paired-Associated Learning test score according to the following ages: Ages 65-70 less than or equal to 18 Ages 71-85* less than or equal to 17
*Eligibility of subjects aged between 70 and 71 (i.e., 70.1) will be evaluated according to 71-85 age group score.
Adequate vision, hearing, and literacy ability to allow for neuropsychological testing.
Able and willing to perform all study procedures.
Ability to provide written consent signed by the subject
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yehudit Aharon, MD | Rambam medical center, Israel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pharmacology Research Institute | Encino | California | 91316 | United States | ||
| Pharmacology Research Institute |
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|
| baseline, 3, 6, 12, 18 and 24 months |
| Mini Sleep Questionnaire (MSQ) | baseline, 12 and 24 months |
| Hamilton Anxiety Rating Scale (HAM-A). | baseline, 12 and 24 months |
| Selective Reminding Test (SRT) | 18 and 24 months |
| Los Alamitos |
| California |
| 90720 |
| United States |
| Pharmacology Research Institute | Newport Beach | California | United States |
| New West Physicians, PC | Golden | Colorado | 80401 | United States |
| Miami Jewish Health Systems | Miami | Florida | 33137 | United States |
| APG Research LLC | Orlando | Florida | 32803 | United States |
| University of South Florida | Tampa | Florida | 33613 | United States |
| Great Lakes Clinical Trials | Chicago | Illinois | 60640 | United States |
| Memory Enhancement Center of America | Eatontown | New Jersey | 07724, | United States |
| Princeton Medical Institute | Princeton | New Jersey | 08540 | United States |
| Integrative Clinical Trials, LLC | Brooklyn | New York | 11229 | United States |
| The Medical Research Network | New York | New York | 10128, | United States |
| Lehigh Center for Clinical Research | Allentown | Pennsylvania | 18104 | United States |
| Rambam medical center, Israel | Haifa | Israel |
| Ichilov medical center | Tel Aviv | Israel |
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D010718 | Phosphatidylserines |
| ID | Term |
|---|---|
| D020404 | Glycerophospholipids |
| D010712 | Phosphatidic Acids |
| D005994 | Glycerophosphates |
| D010743 | Phospholipids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
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