Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2026-01-01 @ 8:16 PM
Study NCT ID:
NCT05050604
Status:
UNKNOWN
Last Update Posted:
2021-09-20
First Post:
2021-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Trial to Evaluate the Efficacy and Safety of Choline Alfoscerate in Vascular Cognitive Impairment Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005997', 'term': 'Glycerylphosphorylcholine'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double Blind (Participant, Investigator)'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 418}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-10', 'studyFirstSubmitDate': '2021-09-10', 'studyFirstSubmitQcDate': '2021-09-10', 'lastUpdatePostDateStruct': {'date': '2021-09-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The proportion of subjects whose cognitive function is maintained/improved at 48 weeks compared to baseline', 'timeFrame': 'Baseline to 48 weeks'}], 'secondaryOutcomes': [{'measure': 'The proportion of subjects reduced by more than or eual 0 points for modified ADAS-Cog score at 24 weeks compared to baseline', 'timeFrame': 'Baseline to 24 weeks', 'description': "ADAS-Cog: Alzheimer's Disease Assessment Scale-Cognitive Subscale"}, {'measure': 'The proportion of subjects reduced by more than 2 points of modified ADAS-Cog score at 24 to 48 weeks compared to baseline', 'timeFrame': 'Baseline, 24 weeks, 48 weeks'}, {'measure': 'The proportion of subjects reduced by more than 4 points of modified ADAS-Cog score at 24 to 48 compared to baseline', 'timeFrame': 'Baseline, 24 weeks, 48 weeks'}, {'measure': 'The change of Modified ADAS-Cog score at 24 to 48 weeks compared to baseline', 'timeFrame': 'Baseline, 24 weeks, 48 weeks'}, {'measure': 'The proportion of subjects increased by more than 0 point of K-MMSE-2 score at 24 and 48 weeks compared to baseline', 'timeFrame': 'Baseline, 24 weeks, 48 weeks', 'description': 'K-MMSE-2: Korean version Mini-Mental State Exam-2'}, {'measure': 'The change of K-MMSE-2 score at 24 to 48 weeks compared to baseline', 'timeFrame': 'Baseline, 24 weeks, 48 weeks'}, {'measure': 'The change of Modified K-MoCA score at 24 to 48 weeks compared to baseline', 'timeFrame': 'Baseline, 24 weeks, 48 weeks', 'description': 'K-MoCA: Korean-Montreal Cognitive Assessment'}, {'measure': 'The change of CDR-SB score at 48 weeks compared to baseline', 'timeFrame': 'Baseline to 48 weeks', 'description': 'CDR-SB: Sum of Boxes of Clinical Dementia Rating'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vascular Cognitive Impairment', 'Choline Alfoscerate'], 'conditions': ['Vascular Cognitive Impairment']}, 'descriptionModule': {'briefSummary': 'This is a multi-center, randomized, double-blind, placebo-controlled, Phase IV Trial to evaluate the efficacy and safety of Choline Alfoscerate compared to placebo in Mild Cognitive Impairment Patients with Cerebrovascular Disease', 'detailedDescription': "Subject will be randomised in a 1:1 ratio to receive either Choline Alfoscerate or it's placebo. Investigational Product(IP, Choline Alfoscerate or it's placebo) will be administered 3 times a day per oral during the treatment"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 50 years\n* Patients with vascular cognitive impairment according to modified Fazekas scale grade 2\\~3 and/or more than 3 of lacunar infarction in Supratentorial\n* Patients with Clinical Deterioration Rating(CDR) score of 0.5\n* Patients with Korean-Montreal Cognitive Assessment (K-MoCA) score of 23 or less\n* Walk or move using walking aids (i.e., walkers, walking sticks or wheelchairs)\n* Written informed consent\n\nExclusion Criteria:\n\n* Clinical diagnosis of dementia (including secondary dementia due to Alzheimer's disease, vascular dementia, infections of the central nervous system (e.g., HIV, syphilis), Creutzfeld-Jacob disease, Pixie disease, Huntington's disease, Parkinson's disease, etc.)\n* Medication of dementia within the past 3 months. (e.g., donepezil, galantamine, rivastigmine, memantine)\n* Medication of brain functional improvement medication within the past 6 weeks. (e.g., citicoline, oxiracetam, piracetam, choline alfoscerate, Nicergoline, Nimodipine, ginko-biloba, acetyl-l carnitine)\n* No studies (no regular school entrance), illiteracy\n* Stroke within the past 3 months\n* Abnormal results from Vitamin B12, Thyroid Stimulated Hormone Test (TSH), HIV-Ab, and VDRL test contribute to or contribute to cognitive impairment of the subject\n* Serious mental disorders such as severe depression, schizophrenia, alcoholism, drug dependence, etc.\n* Severe cardiovascular disease such as myocardial infarction, unstable angina or heart failure within the past 6 months"}, 'identificationModule': {'nctId': 'NCT05050604', 'briefTitle': 'A Clinical Trial to Evaluate the Efficacy and Safety of Choline Alfoscerate in Vascular Cognitive Impairment Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chong Kun Dang Pharmaceutical'}, 'officialTitle': 'A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase IV Trial to Evaluate the Efficacy and Safety of Choline Alfoscerate Compared to Placebo in Mild Cognitive Impairment Patients With Cerebrovascular Disease', 'orgStudyIdInfo': {'id': 'INFINITE-V (B78_03VCI2004)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Choline Alfoscerate', 'interventionNames': ['Drug: Choline Alfoscerate 400mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo of Choline Alfoscerate', 'interventionNames': ['Drug: Placebo of Choline Alfoscerate 400mg']}], 'interventions': [{'name': 'Choline Alfoscerate 400mg', 'type': 'DRUG', 'description': 'Choline Alfoscerate 400mg per oral 3 times a day during the entrie treatment period', 'armGroupLabels': ['Choline Alfoscerate']}, {'name': 'Placebo of Choline Alfoscerate 400mg', 'type': 'DRUG', 'description': 'Placebo of Choline Alfoscerate 400mg per oral 3 times a day during the entrie treatment period', 'armGroupLabels': ['Placebo of Choline Alfoscerate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05505', 'city': 'Seoul', 'country': 'South Korea', 'contacts': [{'name': 'Sun U Kwon', 'role': 'CONTACT', 'email': 'sukwon@amc.seooul.kr', 'phone': '+82230103440'}], 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Sun U Kwon, MD, PhD', 'role': 'CONTACT', 'email': 'sukwon@amc.seoul.kr', 'phone': '+82230103440'}], 'overallOfficials': [{'name': 'Sun U Kwon, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chong Kun Dang Pharmaceutical', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Choline Alfoscerate Re-evaluation Consortium (57 pharmaceutical companies)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}