Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2026-01-22 @ 1:43 PM
Study NCT ID:
NCT02239003
Status:
COMPLETED
Last Update Posted:
2018-01-24
First Post:
2014-09-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NMDA-enhancing Agent for the Treatment of Mild Cognitive Impairment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-23', 'studyFirstSubmitDate': '2014-09-09', 'studyFirstSubmitQcDate': '2014-09-10', 'lastUpdatePostDateStruct': {'date': '2018-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}}, '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'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in speed of processing (Category Fluency) at week 24', 'timeFrame': 'week 0, 24'}, {'measure': "Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input at week 8, 16 and 24", 'timeFrame': 'week 8, 16, 24'}, {'measure': 'Change from baseline in working memory (Wechsler Memory Scale, Spatial Span) at week 24', 'timeFrame': 'week 0, 24'}, {'measure': 'Change from baseline in verbal learning and memory tests (Wechsler Memory Scale, Word Listing) at week 24', 'timeFrame': 'week 0, 24'}]}, 'conditionsModule': {'conditions': ['Mild Cognitive Impairment']}, 'descriptionModule': {'briefSummary': 'NMDA neurotransmission plays an important role in learning and memory. NMDA receptors were found to decrease in the frontal lobe and hippocampus of mild cognitive impairment. This study is a randomized, double-blind, placebo-controlled drug trial. All subjects will be allocated randomly to 2 groups: (1) NMDA-enhancer: DAOIB group (starting dose: 250-500 mg/d); (2) placebo group. The study period is 24 weeks. The investigators hypothesize that DAOIB may yield better efficacy than placebo for cognitive function in patients with mild cognitive impairment.'}, '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\n* MMSE between 17-26\n* CDR 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': 'NCT02239003', 'briefTitle': 'NMDA-enhancing Agent for the Treatment of Mild Cognitive Impairment', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'orgStudyIdInfo': {'id': '103-3642C'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DAOIB', 'description': '250-1500 mg/day, oral, for 24 weeks', 'interventionNames': ['Drug: DAOIB']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'placebo, oral, for 24 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'DAOIB', 'type': 'DRUG', 'armGroupLabels': ['DAOIB']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '886', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Kaohsiung Chang Gung Memorial Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}], 'overallOfficials': [{'name': 'Chieh-Hsin Lin, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chang Gung Memorial Hospital'}, {'name': 'Hsien-Yuan Lane, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'China Medical University, China'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Chieh-Hsin Lin', 'investigatorAffiliation': 'Chang Gung Memorial Hospital'}}}}