Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2026-02-26 @ 7:07 AM
Study NCT ID:
NCT02648906
Status:
UNKNOWN
Last Update Posted:
2016-11-02
First Post:
2016-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Trial for an Evaluation of Choline Alfoscerate and Donepezil for Cognitive Improvements of Patients With Cerebrovascular Injury in Alzheimer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, '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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 128}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2016-01-05', 'studyFirstSubmitQcDate': '2016-01-05', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change of ADAS-cog score compared with Baseline', 'timeFrame': '48 weeks', 'description': 'Primary outcome will be evaluated with ADAS-cog questionnaire 48 weeks after taking investigational product.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Alzheimer Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate efficacy and safety of Choline alfoscerate and Donepezil for cognitive improvements of patients with cerebrovascular injury in Alzheimer patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '56 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. 56\\~90 male and female\n2. Mini-Mental State Evaluation (MMSE) between 24 and 12\n3. Score ≥ 2 at the New Rating Scale for Age-related White Matter Changes (ARWMC), the rating scale of cerebral ischemic injury evaluated with MRI\n4. Score 0.5, 1, 2 at CDR\n5. presence of at least two of the following vascular risk factors: hypertension, diabetes, obesity, ischemic heart disease, dyslipidemia, hyperhomocysteinemia, smoking, previous cerebrovascular events and familiar history of cardio-cerebrovascular diseases.\n6. donepezil 10mg from 3 months ago, dose not changed during clinical trials\n7. A subject who provided written informed consent to participate in this study and cooperative with regard to compliance with study related constraints\n\nExclusion Criteria:\n\n1. Subjects allergic to or sensitive to the Investigational Product or applicable ingredients\n2. subject who has taken below medication 1 month before screening 1) Cholinesterase Inhibitors 2) NMDA receptor antagonists 3) blood circulation supplements 4) Acetyl-L-Carnitines 5) Nicergoline 6) Subject who has taken another medication that can affect the result of primary outcome\n3. subject that can't be evaluated with ADAS-cog, MMSE, NPI, ADL, CDR, Attention Questionnaire Scale etc.\n4. Asthma, COPD\n5. Decompensated heart disease\n6. Chronic renal failure or chronic liver disease\n7. Malignant tumor\n8. Subject that cant' be followed up for 12 months after Investigational drug was taken.\n\n9 Subjects who are pregnant, lactating or who plan to be pregnant during the clinical period or females of child bearing years who do not use available contraceptive methods 10. Subject who has taken other clinical or licensed medication from another clinical trial within 30 days prior screening period 11.Other subjects who are deemed not to be appropriate for this clinical study in the discretion of investigator"}, 'identificationModule': {'nctId': 'NCT02648906', 'briefTitle': 'A Clinical Trial for an Evaluation of Choline Alfoscerate and Donepezil for Cognitive Improvements of Patients With Cerebrovascular Injury in Alzheimer Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daewoong Pharmaceutical Co. LTD.'}, 'orgStudyIdInfo': {'id': 'DWB_GTM001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Choline alfoscerate', 'description': 'Drug: Choline alfoscerate and Donepezil\n\nconcomitant administration', 'interventionNames': ['Drug: Choline alfoscerate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Drug: Donepezil only', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Choline alfoscerate', 'type': 'DRUG', 'armGroupLabels': ['Choline alfoscerate']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sungnam', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital'}], 'centralContacts': [{'name': 'Jina Song', 'role': 'CONTACT', 'email': 'jnsong058@daewoong.co.kr', 'phone': '82-2-550-8865'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daewoong Pharmaceutical Co. LTD.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}