Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2025-12-27 @ 9:40 PM
Study NCT ID:
NCT05582161
Status:
RECRUITING
Last Update Posted:
2024-02-07
First Post:
2022-10-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Biomarkers of DAOIB for Dementia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 123}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-06', 'studyFirstSubmitDate': '2022-10-13', 'studyFirstSubmitQcDate': '2022-10-13', 'lastUpdatePostDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change from baseline in the Alzheimer's disease assessment scale - cognitive subscale at week 8, 16 and 24", 'timeFrame': 'week 0, 8, 16, 24', 'description': "Alzheimer's disease assessment scale-cognitive subscale scores range from 0 (best) to 70 (worst)"}], 'secondaryOutcomes': [{'measure': 'Change from baseline in the composite score of a battery of additional cognitive tests at week 24', 'timeFrame': 'week 0, 24', 'description': 'The battery of additional cognitive tests include speed of processing (Category Fluency), working memory (Wechsler Memory Scale, Spatial Span), verbal/nonverbal learning and memory tests (Wechsler Memory Scale, Word Listing)'}, {'measure': "Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input score at week 8, 16 and 24", 'timeFrame': 'week 8, 16, 24', 'description': "Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input score at week 8, 16 and 24"}, {'measure': "Change from baseline in Alzheimer's disease Cooperative Study scale for ADL in MCI (ADCS-MCI-ADL) score at week 8, 16 and 24", 'timeFrame': 'week 0, 8, 16, 24', 'description': 'The assessment appears to be a suitable instrument for evaluating activities of daily living in early-phase dementia. Its scores range from 0 (worst) to 78 (best)'}, {'measure': 'Change from baseline of Geriatric Depression Scale', 'timeFrame': 'week 0, 8, 16, 24', 'description': 'Assessment of geriatric depressive symptoms'}, {'measure': 'Change from baseline in Mini-Mental Status examination score at week 8, 16 and 24', 'timeFrame': 'week 0, 8, 16, 24', 'description': 'Change from baseline in Mini-Mental Status examination score at week 8, 16 and 24'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dementia']}, 'descriptionModule': {'briefSummary': 'This open-label clinical trial will enroll patients with aMCI or mild AD, and they will be treated with DAOIB for 24 weeks. We will assess the patients before entering the study, 8 weeks, 16 weeks, and end point (24 weeks) of the study, and measure blood NMDA and oxidative stress - related biomarkers every 8 weeks. We hypothesize that NMDA and oxidative stress - related biomarkers can predict the efficacy of DAOIB for patients with aMCI or mild AD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Clinical diagnosis of Alzheimer's disease or mild cognitive impairment\n* MMSE between 10-26\n* CDR 1 or 0.5\n\nExclusion Criteria:\n\n* Hachinski Ischemic Score \\> 4\n* Substance abuse/dependence\n* Parkinson disease, epilepsy, dementia with psychotic features\n* Major depressive disorder\n* Major physical illnesses\n* Severe visual or hearing impairment"}, 'identificationModule': {'nctId': 'NCT05582161', 'briefTitle': 'Efficacy Biomarkers of DAOIB for Dementia', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'Efficacy Biomarkers of DAOIB for Dementia', 'orgStudyIdInfo': {'id': '202101070A3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DAOIB', 'interventionNames': ['Drug: DAOIB']}], 'interventions': [{'name': 'DAOIB', 'type': 'DRUG', 'description': 'The DAOIB dose will be adjusted every 8 weeks according to clinical evaluation.', 'armGroupLabels': ['DAOIB']}]}, 'contactsLocationsModule': {'locations': [{'zip': '886', 'city': 'Kaohsiung City', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Chieh-Hsin Lin, MD, PhD', 'role': 'CONTACT', 'email': 'cyndi36@gmail.com', 'phone': '886-7-7317123', 'phoneExt': '8907'}, {'name': 'Chieh-Hsin Lin, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chang Gung Memorial Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'city': 'Taichung', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Hsien-Yuan Lane, MD, PhD', 'role': 'CONTACT', 'email': 'hylane@gmail.com', 'phone': '886-4-22052121'}], 'facility': 'China Medical University Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}