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

Primary Purpose

Supplement, Cognition Disorders in Old Age, Vision

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Erinacine A-enriched Hericium Erinaceus Mycelia
Placebo
Sponsored by
Chung Shan Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Supplement focused on measuring Erinacine A, supplement, Alzheimer's disease

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chung Shan Medical University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental

Placebo

Arm Description

Erinacine A-enriched Hericium Erinaceus Mycelia dietary supplement from week 0 to week 49.

Placebo dietary supplement from week 0 to week 49.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 15, 2019
Last Updated
August 20, 2019
Sponsor
Chung Shan Medical University
Collaborators
Grape King Bio Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04065061
Brief Title
Erinacine A-enriched Hericium Erinaceus Mycelia for Improvement of Recognition, Vision, and Functional MRI Alterations
Official Title
Investigation of Erinacine A-enriched Hericium Erinaceus Mycelia for Improvement of Recognition, Vision, and Functional MRI Alterations
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
May 22, 2015 (Actual)
Primary Completion Date
May 10, 2016 (Actual)
Study Completion Date
May 10, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chung Shan Medical University
Collaborators
Grape King Bio Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Supplement, Cognition Disorders in Old Age, Vision, fMRI
Keywords
Erinacine A, supplement, Alzheimer's disease

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Double Blinded placebo study
Masking
ParticipantCare ProviderInvestigator
Masking Description
to be completed
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
Erinacine A-enriched Hericium Erinaceus Mycelia dietary supplement from week 0 to week 49.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo dietary supplement from week 0 to week 49.
Intervention Type
Dietary Supplement
Intervention Name(s)
Erinacine A-enriched Hericium Erinaceus Mycelia
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo supplement was given to the participants.
Primary Outcome Measure Information:
Title
Mini-Mental State Examination(MMSE)
Description
Assess changes of Mini-Mental State Examination(MMSE) on weeks 0, 12, 24, and 49.
Time Frame
weeks 0,12, 24, and 49
Title
Neuropsychiatric Inventory (NPI)
Description
Assess changes of Neuropsychiatric Inventory (NPI) on weeks 0, 12, 24, and 49.
Time Frame
weeks 0,12, 24, and 49
Title
Cognitive Abilities Screening Instrument (CASI)
Description
Assess changes of Cognitive Abilities Screening Instrument (CASI) on weeks 0, 12, 24, and 49.
Time Frame
weeks 0,12, 24, and 49
Title
Instrumental Activities of Daily Living (IADL)
Description
Assess changes of Instrumental Activities of Daily Living (IADL) on weeks 0, 12, 24, and 49.
Time Frame
weeks 0,12, 24, and 49
Title
Dehydroepiandrosterone sulfate (DHEAS)
Description
Assess changes of DHEAS on weeks 0, 24, and 49.
Time Frame
weeks 0, 24, and 49
Title
Alpha 1-antichymotrypsin
Description
Assess changes of Alpha 1-antichymotrypsinon weeks 0, 24, and 49.
Time Frame
weeks 0, 24, and 49
Title
Superoxide Dismutase
Description
Assess changes of Superoxide Dismutase on weeks 0, 24, and 49.
Time Frame
weeks 0, 24, and 49
Title
Homocysteine
Description
Assess changes of Homocysteine on weeks 0, 24, and 49.
Time Frame
weeks 0, 24, and 49
Title
Apolipoprotein E
Description
Assess changes of Apolipoprotein E on weeks 0, 24, and 49.
Time Frame
weeks 0, 24, and 49
Title
Hemoglobin
Description
Assess changes of Hemoglobin on weeks 0, 24, and 49.
Time Frame
weeks 0, 24, and 49
Title
Calcium
Description
Assess changes of Calcium on weeks 0, 24, and 49.
Time Frame
weeks 0, 24, and 49
Title
Albumin
Description
Assess changes of Albumin on weeks 0, 24, and 49.
Time Frame
weeks 0, 24, and 49
Title
Amyloid Beta
Description
Assess changes of Amyloid Beta on weeks 0, 24, and 49.
Time Frame
weeks 0, 24, and 49
Title
fMRI-Super-resolution Track Density Imaging (TDI)
Description
Assess changes of Super-resolution Track Density Imaging (TDI) on weeks 0 and 49.
Time Frame
weeks 0 and 49
Title
fMRI-Blood Oxygenation Level-Dependent (BOLD) Signal Mapping
Description
Assess changes of Blood Oxygenation Level-Dependent (BOLD) Signal Mapping, on weeks 0 and 49.
Time Frame
weeks 0 and 49
Title
Vision Assessments-Visual Acuity (VA)
Description
Assess changes of Visual Acuity (VA) on weeks 0, 24, and 49.
Time Frame
weeks 0, 24, and 49
Title
Vision Assessments-Contrast Sensitivity (CS)
Description
Assess changes of Contrast Sensitivity (CS) on weeks 0, 24, and 49.
Time Frame
weeks 0, 24, and 49

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Pei-Cheng Lin, PhD
Organizational Affiliation
Chung Shan Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chung Shan Medical University Hospital
City
Taichung
ZIP/Postal Code
40201
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32581767
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.
Results Reference
derived

Learn more about this trial

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

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