- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04065061
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
Status
Completed
Conditions
Intervention / Treatment
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
-
-
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Taichung, Taiwan, 40201
- Chung Shan Medical University Hospital
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-
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.
Sponsor
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
Additional Relevant MeSH Terms
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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