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

August 20, 2019 updated by: David Pei-Cheng Lin, Chung Shan Medical University

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

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Taichung, Taiwan, 40201
        • Chung Shan Medical University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
Erinacine A-enriched Hericium Erinaceus Mycelia dietary supplement from week 0 to week 49.
Placebo Comparator: Placebo
Placebo dietary supplement from week 0 to week 49.
Placebo supplement was given to the participants.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: David Pei-Cheng Lin, PhD, Chung Shan Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 22, 2015

Primary Completion (Actual)

May 10, 2016

Study Completion (Actual)

May 10, 2017

Study Registration Dates

First Submitted

August 15, 2019

First Submitted That Met QC Criteria

August 20, 2019

First Posted (Actual)

August 22, 2019

Study Record Updates

Last Update Posted (Actual)

August 22, 2019

Last Update Submitted That Met QC Criteria

August 20, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • CS15049

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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