Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2026-01-17 @ 11:17 AM
Study NCT ID:
NCT06761066
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-13
First Post:
2024-12-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of NVP-NK4146 in Patients with Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-09', 'studyFirstSubmitDate': '2024-12-17', 'studyFirstSubmitQcDate': '2025-01-04', 'lastUpdatePostDateStruct': {'date': '2025-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'amyloid PET scan', 'timeFrame': 'baseline and 36 weeks', 'description': 'Changes in brain amyloid measured by amyloid PET scan from baseline to 36 weeks'}], 'secondaryOutcomes': [{'measure': "ADAS-Cog(Alzheimer's Disease Assessment Scale-Cognitive Subscale)13", 'timeFrame': 'baseline and 36 weeks', 'description': 'Changes in ADAS-Cog 13 total score, memory score, and subscales from baseline to 36 weeks'}, {'measure': 'CDR-SB(Clinical Dementia Rating-Sum of Boxes)', 'timeFrame': 'baseline and 36 weeks', 'description': 'Changes in CDR-SB(Clinical Dementia Rating-Sum of Boxes) and CDR total score from baseline to 36 weeks'}, {'measure': 'GDS (Global Deterioration Scale)', 'timeFrame': 'baseline and 36 weeks', 'description': 'Change in GDS total score from baseline to 36 weeks'}, {'measure': 'K-MMSE (the Korean Mini-Mental State Examination)', 'timeFrame': 'baseline and 36 weeks', 'description': 'Change in K-MMSE total score from baseline to 36 weeks'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alzheimer Disease']}, 'descriptionModule': {'briefSummary': "The purpose of this clinical trial is to exploratively evaluate the efficacy and safety of NVP -NK4146 in improving mild cognitive impairment (MCI) in patients with due to Alzheimer's disease (AD) compared to placebo", 'detailedDescription': '36-week, single-center, randomized, double-blind, parallel-design, placebo-controlled trial'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male and female adults aged 60 or older\n2. Subject who meet the National Institute of Aging and Alzheimer's Associations (NIA-AA) core clinical criteria for MCI and have positive readings from amyloid PET\n3. Subject who can read and understand the Informed Consent Form and legends and who voluntarily decided to participate in current clinical trial and have signed the Informed Consent Form\n\nExclusion Criteria:\n\n1. Subject diagnosed with dementia according to the criteria of DSM-5 or ICD-10\n2. Subject currently receiving treatment for malignant tumors (except those who have fully recovered from cancer for more than 5 years or those with basal cell carcinoma, squamous cell carcinoma, or prostate cancer may participate at the investigator's discretion)\n3. Subject who are illiterate and/or without any education\n4. Any other factors deemed by the investigator to be likely to ineligible for the study"}, 'identificationModule': {'nctId': 'NCT06761066', 'briefTitle': "Efficacy and Safety of NVP-NK4146 in Patients with Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'NVP Healthcare'}, 'officialTitle': "36-week, Single-center, Randomized, Double-blind, Parallel-design, Placebo-controlled Trial to Determine the Safety and Efficacy of NVP-NK4146 in Patients with Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease", 'orgStudyIdInfo': {'id': 'NVP-NK4146_HS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active Group', 'description': 'NVP-NK4146', 'interventionNames': ['Dietary Supplement: NVP-NK4146']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group', 'description': 'NVP-NK4146 Placebo', 'interventionNames': ['Dietary Supplement: NVP-NK4146 Placebo']}], 'interventions': [{'name': 'NVP-NK4146', 'type': 'DIETARY_SUPPLEMENT', 'description': 'BID for 36 weeks orally', 'armGroupLabels': ['Active Group']}, {'name': 'NVP-NK4146 Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'BID for 36 weeks orally', 'armGroupLabels': ['Placebo Group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Hyun Kook Lim, M.D./Ph.D.', 'role': 'CONTACT', 'email': 'drblues@catholic.ac.kr', 'phone': '+82-2-3779-1880'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NVP Healthcare', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}