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

fMRI Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04065061
• Other study ID #: CS15049
• Status: Completed
• Phase: N/A
• Start date: May 22, 2015
• Est. completion date: May 10, 2017

Study information

• Verified date: August 2019
• Source: Chung Shan Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: May 10, 2017
• Est. primary completion date: May 10, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognition Disorders
• Cognition Disorders in Old Age
• fMRI
• Supplement
• Vision

Intervention

Dietary Supplement:
• Erinacine A-enriched Hericium Erinaceus Mycelia

• Placebo
Placebo supplement was given to the participants.

Locations

Country	Name	City	State
Taiwan	Chung Shan Medical University Hospital	Taichung

Sponsors (2)

Lead Sponsor	Collaborator
Chung Shan Medical University	Grape King Bio Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

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