Ignite Creation Date:
2025-12-24 @ 11:58 AM
Ignite Modification Date:
2026-02-01 @ 10:23 AM
Study NCT ID:
NCT04065061
Status:
COMPLETED
Last Update Posted:
2019-08-22
First Post:
2019-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Erinacine A-enriched Hericium Erinaceus Mycelia for Improvement of Recognition, Vision, and Functional MRI Alterations
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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'to be completed'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized Double Blinded placebo study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2017-05-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-20', 'studyFirstSubmitDate': '2019-08-15', 'studyFirstSubmitQcDate': '2019-08-20', 'lastUpdatePostDateStruct': {'date': '2019-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-05-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mini-Mental State Examination(MMSE)', 'timeFrame': 'weeks 0,12, 24, and 49', 'description': 'Assess changes of Mini-Mental State Examination(MMSE) on weeks 0, 12, 24, and 49.'}, {'measure': 'Neuropsychiatric Inventory (NPI)', 'timeFrame': 'weeks 0,12, 24, and 49', 'description': 'Assess changes of Neuropsychiatric Inventory (NPI) on weeks 0, 12, 24, and 49.'}, {'measure': 'Cognitive Abilities Screening Instrument (CASI)', 'timeFrame': 'weeks 0,12, 24, and 49', 'description': 'Assess changes of Cognitive Abilities Screening Instrument (CASI) on weeks 0, 12, 24, and 49.'}, {'measure': 'Instrumental Activities of Daily Living (IADL)', 'timeFrame': 'weeks 0,12, 24, and 49', 'description': 'Assess changes of Instrumental Activities of Daily Living (IADL) on weeks 0, 12, 24, and 49.'}, {'measure': 'Dehydroepiandrosterone sulfate (DHEAS)', 'timeFrame': 'weeks 0, 24, and 49', 'description': 'Assess changes of DHEAS on weeks 0, 24, and 49.'}, {'measure': 'Alpha 1-antichymotrypsin', 'timeFrame': 'weeks 0, 24, and 49', 'description': 'Assess changes of Alpha 1-antichymotrypsinon weeks 0, 24, and 49.'}, {'measure': 'Superoxide Dismutase', 'timeFrame': 'weeks 0, 24, and 49', 'description': 'Assess changes of Superoxide Dismutase on weeks 0, 24, and 49.'}, {'measure': 'Homocysteine', 'timeFrame': 'weeks 0, 24, and 49', 'description': 'Assess changes of Homocysteine on weeks 0, 24, and 49.'}, {'measure': 'Apolipoprotein E', 'timeFrame': 'weeks 0, 24, and 49', 'description': 'Assess changes of Apolipoprotein E on weeks 0, 24, and 49.'}, {'measure': 'Hemoglobin', 'timeFrame': 'weeks 0, 24, and 49', 'description': 'Assess changes of Hemoglobin on weeks 0, 24, and 49.'}, {'measure': 'Calcium', 'timeFrame': 'weeks 0, 24, and 49', 'description': 'Assess changes of Calcium on weeks 0, 24, and 49.'}, {'measure': 'Albumin', 'timeFrame': 'weeks 0, 24, and 49', 'description': 'Assess changes of Albumin on weeks 0, 24, and 49.'}, {'measure': 'Amyloid Beta', 'timeFrame': 'weeks 0, 24, and 49', 'description': 'Assess changes of Amyloid Beta on weeks 0, 24, and 49.'}, {'measure': 'fMRI-Super-resolution Track Density Imaging (TDI)', 'timeFrame': 'weeks 0 and 49', 'description': 'Assess changes of Super-resolution Track Density Imaging (TDI) on weeks 0 and 49.'}, {'measure': 'fMRI-Blood Oxygenation Level-Dependent (BOLD) Signal Mapping', 'timeFrame': 'weeks 0 and 49', 'description': 'Assess changes of Blood Oxygenation Level-Dependent (BOLD) Signal Mapping, on weeks 0 and 49.'}, {'measure': 'Vision Assessments-Visual Acuity (VA)', 'timeFrame': 'weeks 0, 24, and 49', 'description': 'Assess changes of Visual Acuity (VA) on weeks 0, 24, and 49.'}, {'measure': 'Vision Assessments-Contrast Sensitivity (CS)', 'timeFrame': 'weeks 0, 24, and 49', 'description': 'Assess changes of Contrast Sensitivity (CS) on weeks 0, 24, and 49.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Erinacine A, supplement, Alzheimer's disease"], 'conditions': ['Supplement', 'Cognition Disorders in Old Age', 'Vision', 'fMRI']}, 'referencesModule': {'references': [{'pmid': '32581767', 'type': 'DERIVED', 'citation': "Li IC, Chang HH, Lin CH, Chen WP, Lu TH, Lee LY, Chen YW, Chen YP, Chen CC, Lin DP. Prevention of Early Alzheimer's Disease by Erinacine A-Enriched Hericium erinaceus Mycelia Pilot Double-Blind Placebo-Controlled Study. Front Aging Neurosci. 2020 Jun 3;12:155. doi: 10.3389/fnagi.2020.00155. eCollection 2020."}]}, 'descriptionModule': {'briefSummary': 'This study was designed as randomized double blind placebo study to investigate the efficacy of Erinacine A-enriched Hericium erinaceus mycelia for improvement of recognition, vision, and functional MRI alterations.', 'detailedDescription': "Patients were recruited with diagnosis of mild or medium dementia, according to criteria by NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association) as probable or possible Alzheimer's disease. Upon signature of informed consent, they were subject to: (1) Cognitive assessments, including Mini-Mental State Examination(MMSE), Neuropsychiatric Inventory (NPI), Cognitive Abilities Screening Instrument (CASI), and Instrumental Activities of Daily Living (IADL) on weeks 0, 12, 24, and 49, (2) Blood Markers Tests, including DHEAS, Alpha 1-antichymotrypsin, Superoxide Dismutase, and Homocysteine, Apolipoprotein E, Hemoglobin, Calcium, Albumin, and Amyloid Beta on weeks 0, 24, and 49, (3) fMRI Assessments for Super-resolution Track Density Imaging (TDI), and Blood Oxygenation Level-Dependent (BOLD) Signal Mapping, on weeks 0 and 49, (4) Vision Assessments, including Visual Acuity (VA) and Contrast Sensitivity (CS), on weeks 0, 24, and 49. Mann-Whitney U test and Wilcoxon tests were applied to examine the data before and after dietary intake of Erinacine A-enriched Hericium Erinaceus Mycelia after 49 weeks."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Aged between 50 and 90\n* Confirmed diagnosis of mild and intermediate Alzheimer's disease based on clinical assessments according to criteria of NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association)\n\nExclusion Criteria:\n\n* vulnerable to injuries\n* loss of self-recognition,\n* loss of behavioral capacity\n* with critical illness\n* with major diseases"}, 'identificationModule': {'nctId': 'NCT04065061', 'briefTitle': 'Erinacine A-enriched Hericium Erinaceus Mycelia for Improvement of Recognition, Vision, and Functional MRI Alterations', 'organization': {'class': 'OTHER', 'fullName': 'Chung Shan Medical University'}, 'officialTitle': 'Investigation of Erinacine A-enriched Hericium Erinaceus Mycelia for Improvement of Recognition, Vision, and Functional MRI Alterations', 'orgStudyIdInfo': {'id': 'CS15049'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'Erinacine A-enriched Hericium Erinaceus Mycelia dietary supplement from week 0 to week 49.', 'interventionNames': ['Dietary Supplement: Erinacine A-enriched Hericium Erinaceus Mycelia']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo dietary supplement from week 0 to week 49.', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Erinacine A-enriched Hericium Erinaceus Mycelia', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Experimental']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo supplement was given to the participants.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40201', 'city': 'Taichung', 'country': 'Taiwan', 'facility': 'Chung Shan Medical University Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'overallOfficials': [{'name': 'David Pei-Cheng Lin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chung Shan Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chung Shan Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Grape King Bio Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'David Pei-Cheng Lin', 'investigatorAffiliation': 'Chung Shan Medical University'}}}}