Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-26 @ 1:07 AM
Study NCT ID:
NCT00736034
Status:
COMPLETED
Last Update Posted:
2010-03-30
First Post:
2008-08-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
The Efficacy of Phosphatidylserine-Omega3 in Elderly Subjects With Memory Impairment
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008569', 'term': 'Memory Disorders'}], 'ancestors': [{'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'vedanicek@gmail.com', 'phone': '972-3-6973698', 'title': 'Dr. V. Vakhapova', 'organization': 'Sourazky Tel-Aviv Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'PS-Omega3', 'description': 'Treatment will consist of capsules containing 100 mg phosphatidylserine-Omega3. Dosage: 1 capsule X 3 times daily, with meals', 'otherNumAtRisk': 18, 'otherNumAffected': 2, 'seriousNumAtRisk': 18, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'gastrointestinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Hepatitis', 'notes': 'Not related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Neuropsychological Computerized Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PS-Omega3', 'description': 'Treatment will consist of capsules containing 100 mg phosphatidylserine-Omega3. Dosage: 1 capsule X 3 times daily, with meals'}], 'classes': [{'title': 'Focused Attention', 'categories': [{'measurements': [{'value': '3.16', 'spread': '12.39', 'groupId': 'OG000'}]}]}, {'title': 'Sustained Attention', 'categories': [{'measurements': [{'value': '-2.38', 'spread': '11.09', 'groupId': 'OG000'}]}]}, {'title': 'Memory - Recognition', 'categories': [{'measurements': [{'value': '1.88', 'spread': '9.86', 'groupId': 'OG000'}]}]}, {'title': 'Memory - Recall', 'categories': [{'measurements': [{'value': '4.50', 'spread': '12.14', 'groupId': 'OG000'}]}]}, {'title': 'VisuoSpatial Learning', 'categories': [{'measurements': [{'value': '8.83', 'spread': '24.31', 'groupId': 'OG000'}]}]}, {'title': 'Spatial Short Term Memory', 'categories': [{'measurements': [{'value': '13.16', 'spread': '29.88', 'groupId': 'OG000'}]}]}, {'title': 'Executive Functions', 'categories': [{'measurements': [{'value': '-2.88', 'spread': '19.72', 'groupId': 'OG000'}]}]}, {'title': 'Mental Flexibility', 'categories': [{'measurements': [{'value': '-3.88', 'spread': '20.21', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 15 weeks', 'description': '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).', 'unitOfMeasure': 'Points on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Global Impression of Change (CGI-C)Scale', 'paramType': 'NUMBER', 'timeFrame': '15 weeks', 'description': '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.', 'unitOfMeasure': 'Participants who experienced improvement', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PS-Omega3', 'description': 'Treatment will consist of capsules containing 100 mg phosphatidylserine-Omega3. Dosage: 1 capsule X 3 times daily, with meals'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': "Participants were recruited through advertisements in senior citizens' homes, hospitals, and newspapers."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'PS-Omega3', 'description': 'Treatment will consist of capsules containing 100 mg phosphatidylserine-Omega3. Dosage: 1 capsule X 3 times daily, with meals'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '75.29', 'spread': '7.09', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Israel', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-03-26', 'studyFirstSubmitDate': '2008-08-14', 'resultsFirstSubmitDate': '2010-03-04', 'studyFirstSubmitQcDate': '2008-08-14', 'lastUpdatePostDateStruct': {'date': '2010-03-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-03-04', 'studyFirstPostDateStruct': {'date': '2008-08-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-03-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Neuropsychological Computerized Test', 'timeFrame': 'baseline, 15 weeks', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Clinical Global Impression of Change (CGI-C)Scale', 'timeFrame': '15 weeks', 'description': '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.'}]}, 'conditionsModule': {'keywords': ['Age Associated Memory Impairment'], 'conditions': ['Memory Impairment']}, 'descriptionModule': {'briefSummary': 'The primary objective of this trial is to assess the ability of Phosphatidylserine-Omega3 to improve cognitive performance in elderly subjects with memory impairment.\n\nThis study is a single-center, open-label 15 weeks duration trial to assess efficacy of Phosphatidylserine-Omega3 in elderly subjects with memory impairment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "INCLUSION CRITERIA\n\n1. Ability to give written informed consent\n2. Age: 90≥ years ≥65\n3. Gender: male and female.\n4. Clinical Dementia Rating Scale (CDR) ≤ 0.5\n5. Mini-Mental State Examination (MMSE) ≥ 26\n6. Memory test performance within or below the mean established for adults, with maximum of four neuropsychological subtests of the computerized test scored as 1.5 SD above the mean\n7. Language: Subjects must be able to read, write and speak Hebrew.\n8. Ability to perform tests and interviews.\n\nEXCLUSION CRITERIA\n\n1. Evidence of delirium, confusion, or other disturbances of consciousness.\n2. 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\n3. History of any infective or inflammatory brain disease including those of viral, fungal, or syphilitic etiologies.\n4. Head injury immediately preceding cognitive deterioration.\n5. Current psychiatric diagnosis according to DSM IV criteria of depression, mania, or any other major psychiatric disorder, or evidence of depression as determined by the Geriatric Depression Scale (GDS15) score of 5 or more.\n6. Current diagnosis or history of alcoholism or drug dependence.\n7. 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.\n8. Use of psychotropic drug or any other drug or supplement that may significantly affect cognitive functioning during the month prior to psychometric testing.\n9. Use of any experimental medication within 1 month prior to screening or as concomitant medications.\n10. History of hypersensitivity or allergy to fish or fish oil."}, 'identificationModule': {'nctId': 'NCT00736034', 'briefTitle': 'The Efficacy of Phosphatidylserine-Omega3 in Elderly Subjects With Memory Impairment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Enzymotec'}, 'officialTitle': 'A Single-Center, Open-Label Study to Assess the Efficacy of SharpPS™-Gold in Elderly Subjects With Memory Impairment', 'orgStudyIdInfo': {'id': 'SharpPS™-Gold 001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Phosphatidylserine-Omega3 (SharpPS™-Gold)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Treatment will consist of capsules containing 100 mg phosphatidylserine-Omega3. Dosage: 1 capsule X 3 times daily, with meals. Duration: 15 weeks'}]}, 'contactsLocationsModule': {'locations': [{'zip': '64239', 'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'The Tel Aviv Sourasky Medical Center, Neurology department', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'overallOfficials': [{'name': 'Veronica Vakhapova, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sourasky Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Enzymotec', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Inbal Eyal M.Sc', 'oldOrganization': 'Enzymotec'}}}}