Ignite Creation Date:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2025-12-25 @ 8:22 PM
Study NCT ID:
NCT01600469
Status:
COMPLETED
Last Update Posted:
2013-06-04
First Post:
2012-05-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
NMDA-enhancing Agent for Treatment of Mild Cognitive Impairment and Mild Alzheimer's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], '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'}, {'id': 'D003072', 'term': 'Cognition Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-03', 'studyFirstSubmitDate': '2012-05-14', 'studyFirstSubmitQcDate': '2012-05-15', 'lastUpdatePostDateStruct': {'date': '2013-06-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change from baseline in Alzheimer's disease assessment scale-cognitive subscale in week 8, 16 and 24", 'timeFrame': 'Week 0, 8, 16, 24'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in Mini Mental Status Examination at week 8, 16 and 24', 'timeFrame': 'Week 0, 8, 16, 24'}, {'measure': 'Change from baseline in Instrumental Activities of Daily Living at week 8, 16 and 24', 'timeFrame': 'Week 0, 8, 16, 24'}, {'measure': 'Change from baseline in Verbal learning and memory at week 24', 'timeFrame': 'Week 0, 24'}, {'measure': 'Change from baseline in Digit Span subtest of the Wechsler Memory Scale at week 24', 'timeFrame': 'Week 0, 24'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["Alzheimer's disease", 'mild cognitive impairment', 'NMDA'], 'conditions': ["Alzheimer's Disease", 'Mild Cognitive Impairment']}, 'descriptionModule': {'briefSummary': "NMDA activation plays an important role in learning and memory. NMDA receptors were found to decrease in the frontal lobe and hippocampus of Alzheimer's disease and mild cognitive function impairment. This study is a randomized, double-blind, placebo-controlled drug trial. All patients will be allocated randomly to 2 groups: (1) NMDA enhancer: DAOI-B group (starting dose: 250-500 mg/d); (2) placebo group. The study period is 24 weeks. The investigators hypothesize that DAOI-B may yield better efficacy than placebo for cognitive function in patients with mild cognitive impairment or mild Alzheimer's disease."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Clinical diagnosis of mild cognitive impairment or mild Alzheimer's\n* MMSE between 17-26\n* CDR 0.5 or 1\n\nExclusion Criteria:\n\n* Hachinski Ischemic Score \\> 4\n* substance abuse/dependence\n* Parkinson disease\n* epilepsy\n* major depressive disorder\n* dementia with psychotic features\n* major physical illnesses\n* severe visual or hearing impairment"}, 'identificationModule': {'nctId': 'NCT01600469', 'briefTitle': "NMDA-enhancing Agent for Treatment of Mild Cognitive Impairment and Mild Alzheimer's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': "NMDA-enhancing Agent for Treatment of Mild Cognitive Impairment and Mild Alzheimer's Disease", 'orgStudyIdInfo': {'id': '99-2452A3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DAOI-B', 'interventionNames': ['Drug: DAOI-B']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'DAOI-B', 'type': 'DRUG', 'description': '250-1500 mg/day, oral, for 24 weeks', 'armGroupLabels': ['DAOI-B']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'placebo, oral, for 24 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '886', 'city': 'Kaohsiung', 'state': 'Taiwan', 'country': 'Taiwan', 'facility': 'Kaohsiung Chang Gung Memorial Hospital'}], 'overallOfficials': [{'name': 'Hsien-yuan Lane, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Departments of Psychiatry, China Medical University Hospital, Taichung, Taiwan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}