Ignite Creation Date:
2025-12-24 @ 2:47 PM
Ignite Modification Date:
2026-01-01 @ 9:37 PM
Study NCT ID:
NCT03249259
Status:
COMPLETED
Last Update Posted:
2019-10-08
First Post:
2017-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Choline Alfoscerate on Improvement of Cognitive Function in Elderly Patients With Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005997', 'term': 'Glycerylphosphorylcholine'}, {'id': 'D002794', 'term': 'Choline'}], 'ancestors': [{'id': 'D005994', 'term': 'Glycerophosphates'}, {'id': 'D000073999', 'term': 'Triose Sugar Alcohols'}, {'id': 'D013402', 'term': 'Sugar Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D020404', 'term': 'Glycerophospholipids'}, {'id': 'D010712', 'term': 'Phosphatidic Acids'}, {'id': 'D010743', 'term': 'Phospholipids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D054709', 'term': 'Lecithins'}, {'id': 'D010713', 'term': 'Phosphatidylcholines'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D050337', 'term': 'Trimethyl Ammonium Compounds'}, {'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D009861', 'term': 'Onium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'double blind placebo controlled study.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-04', 'studyFirstSubmitDate': '2017-08-09', 'studyFirstSubmitQcDate': '2017-08-11', 'lastUpdatePostDateStruct': {'date': '2019-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Hypoglycemia', 'timeFrame': '6 months', 'description': 'Incidence of hypoglycemia'}], 'primaryOutcomes': [{'measure': 'Cognitive function', 'timeFrame': '6 months', 'description': 'Change of MMSE Score'}], 'secondaryOutcomes': [{'measure': 'Glucose metabolism', 'timeFrame': '6 months', 'description': 'Changes in HbA1c'}, {'measure': 'Glucose metabolism', 'timeFrame': '6 months', 'description': 'Changes in fasting glucose concentration'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'In this study, the investigators are going to investigate the efficacy of choline alfoscerate on improvement of cognitive function assessed by MMSE compared to plaebo.', 'detailedDescription': 'The investigators will enroll patients with type 2 diabetes whose age is equal to higher than 60, and randomly assigned study drug or placebo at 1:1 ratio. The treatment duration is 6 months and extension study will be continued to 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* type 2 diabetes\n* baseline MMSE score 25-28\n\nExclusion Criteria:\n\n* type 1 diabetes\n* diabetes ketoacidosis or hyperosmolar hyperglycemic crisis\n* HbA1c over than 9.0%\n* MMSE less than 25\n* abnormal TSH levels\n* vitamin B12 deficiency\n* severe infection, perioperative state, trauma\n* hypopituitarism or adrenal insufficiency\n* any conditions that lead to hospitalization\n* chronic alcoholics within 1 year\n* any drugs that can influence to cognitive function within 3 months'}, 'identificationModule': {'nctId': 'NCT03249259', 'briefTitle': 'The Effect of Choline Alfoscerate on Improvement of Cognitive Function in Elderly Patients With Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Bundang Hospital'}, 'officialTitle': 'The Effect of Choline Alfoscerate on Improvement of Cognitive Function in Elderly Patients With Diabetes', 'orgStudyIdInfo': {'id': 'B-1508-312-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Choline alfoscerate', 'description': 'choline alfoscerate 400mg (2 caps - 1 cap bid)', 'interventionNames': ['Drug: Choline alfoscerate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Placebo (2 caps - 1 cap bid)', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Choline alfoscerate', 'type': 'DRUG', 'otherNames': ['Choline'], 'description': "Treatment duration is 6 months and can be extended to 12 months with participant's agreement.", 'armGroupLabels': ['Choline alfoscerate']}, {'name': 'Placebo', 'type': 'DRUG', 'description': "Treatment duration is 6 months and can be extended to 12 months with participant's agreement.", 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '463-707', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Soo Lim', 'investigatorAffiliation': 'Seoul National University Bundang Hospital'}}}}