Erinacine A-enriched Hericium Erinaceus Mycelia for Improvement of Recognition, Vision, and Functional MRI Alterations

Not Applicable

Completed

• Conditions: Vision; Cognition Disorders in Old Age; fMRI; Supplement
• Interventions: Dietary Supplement: Erinacine A-enriched Hericium Erinaceus Mycelia; Dietary Supplement: Placebo

• Registration Number: NCT04065061
• Lead Sponsor: Chung Shan Medical University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2015-05-22
• Primary Completion: 2016-05-10
• Study Completion: 2017-05-10
• Status Verified: 2019-08
• Study First Submitted: 2019-08-15
• Study First Submitted QC: 2019-08-20
• Last Update Submitted: 2019-08-20
• Study First Posted: 2019-08-22
• Last Update Posted: 2019-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• Aged between 50 and 90
• 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)

Exclusion Criteria

• vulnerable to injuries
• loss of self-recognition,
• loss of behavioral capacity
• with critical illness
• with major diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Erinacine A-enriched Hericium Erinaceus Mycelia	Erinacine A-enriched Hericium Erinaceus Mycelia dietary supplement from week 0 to week 49.
Placebo	Placebo	Placebo dietary supplement from week 0 to week 49.

Primary Outcome Measures

Name	Time	Method
fMRI-Blood Oxygenation Level-Dependent (BOLD) Signal Mapping	weeks 0 and 49	Assess changes of Blood Oxygenation Level-Dependent (BOLD) Signal Mapping, on weeks 0 and 49.
Vision Assessments-Visual Acuity (VA)	weeks 0, 24, and 49	Assess changes of Visual Acuity (VA) on weeks 0, 24, and 49.
Vision Assessments-Contrast Sensitivity (CS)	weeks 0, 24, and 49	Assess changes of Contrast Sensitivity (CS) on weeks 0, 24, and 49.
Neuropsychiatric Inventory (NPI)	weeks 0,12, 24, and 49	Assess changes of Neuropsychiatric Inventory (NPI) on weeks 0, 12, 24, and 49.
Instrumental Activities of Daily Living (IADL)	weeks 0,12, 24, and 49	Assess changes of Instrumental Activities of Daily Living (IADL) on weeks 0, 12, 24, and 49.
Cognitive Abilities Screening Instrument (CASI)	weeks 0,12, 24, and 49	Assess changes of Cognitive Abilities Screening Instrument (CASI) on weeks 0, 12, 24, and 49.
Albumin	weeks 0, 24, and 49	Assess changes of Albumin on weeks 0, 24, and 49.
Amyloid Beta	weeks 0, 24, and 49	Assess changes of Amyloid Beta on weeks 0, 24, and 49.
Mini-Mental State Examination(MMSE)	weeks 0,12, 24, and 49	Assess changes of Mini-Mental State Examination(MMSE) on weeks 0, 12, 24, and 49.
Dehydroepiandrosterone sulfate (DHEAS)	weeks 0, 24, and 49	Assess changes of DHEAS on weeks 0, 24, and 49.
Apolipoprotein E	weeks 0, 24, and 49	Assess changes of Apolipoprotein E on weeks 0, 24, and 49.
Homocysteine	weeks 0, 24, and 49	Assess changes of Homocysteine on weeks 0, 24, and 49.
Calcium	weeks 0, 24, and 49	Assess changes of Calcium on weeks 0, 24, and 49.
fMRI-Super-resolution Track Density Imaging (TDI)	weeks 0 and 49	Assess changes of Super-resolution Track Density Imaging (TDI) on weeks 0 and 49.
Alpha 1-antichymotrypsin	weeks 0, 24, and 49	Assess changes of Alpha 1-antichymotrypsinon weeks 0, 24, and 49.
Superoxide Dismutase	weeks 0, 24, and 49	Assess changes of Superoxide Dismutase on weeks 0, 24, and 49.
Hemoglobin	weeks 0, 24, and 49	Assess changes of Hemoglobin on weeks 0, 24, and 49.

Trial Locations

Locations (1)

Chung Shan Medical University Hospital; 🇨🇳 Taichung, Taiwan