Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2025-12-26 @ 4:09 AM
Study NCT ID:
NCT04229927
Status:
UNKNOWN
Last Update Posted:
2020-04-22
First Post:
2020-01-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
BPDO-1603 Intervention Trial in Patients With Moderate-to-severe Alzheimer's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 712}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2023-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-20', 'studyFirstSubmitDate': '2020-01-13', 'studyFirstSubmitQcDate': '2020-01-13', 'lastUpdatePostDateStruct': {'date': '2020-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in SIB total scores', 'timeFrame': 'from baseline to Week 24'}, {'measure': 'CIBIC-plus total score', 'timeFrame': 'at Week 24 (Baseline score will be from CIBIS'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ["Moderate-to-severe Alzheimer's Disease"]}, 'descriptionModule': {'briefSummary': "A multicenter, randomized, double-blind, active-controlled, phase III clinical trial to evaluate the efficacy and safety of BPDO-1603 in patients with moderate-to-severe Alzheimer's disease"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* A voluntary, written informed consent from the patient or the patient´s representative.\n* Male or female patients ≥ 45 years of age as of the date of informed consent.\n* Diagnosed with probable AD according to the National Institute on Aging-Alzheimer's Association \\[NIA-AA (2011)\\] criteria.\n* MMSE score of ≥ 5 and ≤ 20 during screening period.\n* CDR-GS of 2 \\~ 3 or GDS of 4 \\~ 7 during screening period.\n* Ongoing cholinesterase inhibitor therapy with stable dose of 10 mg/day donepezil hydrochloride for more than 12 weeks (inclusive) prior to screening, and can continue this therapy until randomization without any change in the dosage regimen of donepezil hydrochloride.\n\nExclusion Criteria:\n\n* Magnetic resonance imaging (MRI) or computed tomography (CT) findings obtained within the past 12 months (ie, 48 weeks) from screening or at screening, as a cause of dementia other than probable AD.\n* History of other organic disease, such as vascular dementia, CNS infections (e.g., human immunodeficiency virus \\[HIV\\], syphilis), head injury, Creutzfeldt-Jakob disease, Niemann-Pick's disease, Huntington's disease, Parkinson's disease, epilepsy, or stroke.\n* Evidence of other neurological disorders which include seizure disorder that may interfere with the patient's cognition or ability to perform the study procedures.\n* Use of Memantine Hydrochloride within 1 month prior to screening"}, 'identificationModule': {'nctId': 'NCT04229927', 'briefTitle': "BPDO-1603 Intervention Trial in Patients With Moderate-to-severe Alzheimer's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Hyundai Pharmaceutical Co., LTD.'}, 'officialTitle': "A Multicenter, Randomized, Double-blind, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of BPDO-1603 in Patients With Moderate-to-severe Alzheimer's Disease", 'orgStudyIdInfo': {'id': 'HT-007-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'interventionNames': ['Drug: BPDO-1603']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm 2', 'interventionNames': ['Drug: BPDO-1603']}], 'interventions': [{'name': 'BPDO-1603', 'type': 'DRUG', 'description': 'Arm1 : 1 tablet of the test drug, and 1 tablet of placebo reference drug\n\nArm2 : 1 tablet of the reference drug, and 1 tablet of placebo test drug', 'armGroupLabels': ['Arm 1', 'Arm 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Incheon', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Seonghye CHOI', 'role': 'CONTACT'}], 'facility': 'Inha University Hospital', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}], 'centralContacts': [{'name': 'Nara LEE', 'role': 'CONTACT', 'email': 'nara.lee@hdpharm.co.kr', 'phone': '82-2-2600-3869'}, {'name': 'Sumin SON', 'role': 'CONTACT', 'email': 'smson@myhdpharm.com', 'phone': '82-2-2600-3817'}], 'overallOfficials': [{'name': 'Seonghye CHOI', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Inha University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hyundai Pharmaceutical Co., LTD.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}