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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04065061
Other study ID # CS15049
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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