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

• Sponsor: Chung Shan Medical University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04065061
• Collaborator: Grape King Bio Ltd. (Industry)
• Enrollment: 68
• Location: 1
• Arms: 2
• Actual Duration (Months): 23.6
• Patients Per Site Per Month: 2.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Supplement; Cognition Disorders in Old Age; Vision; fMRI	Dietary Supplement: Erinacine A-enriched Hericium Erinaceus Mycelia; Dietary Supplement: Placebo	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 68 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized Double Blinded placebo studyRandomized Double Blinded placebo study
• Masking: Triple (Participant, Care Provider, Investigator)
• Masking Description: to be completed
• Primary Purpose: Other
• Official Title: Investigation of Erinacine A-enriched Hericium Erinaceus Mycelia for Improvement of Recognition, Vision, and Functional MRI Alterations
• Actual Study Start Date: May 22, 2015
• Actual Primary Completion Date: May 10, 2016
• Actual Study Completion Date: May 10, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Mini-Mental State Examination(MMSE) [weeks 0,12, 24, and 49]

   Assess changes of Mini-Mental State Examination(MMSE) on weeks 0, 12, 24, and 49.

2. Neuropsychiatric Inventory (NPI) [weeks 0,12, 24, and 49]

   Assess changes of Neuropsychiatric Inventory (NPI) on weeks 0, 12, 24, and 49.

3. Cognitive Abilities Screening Instrument (CASI) [weeks 0,12, 24, and 49]

   Assess changes of Cognitive Abilities Screening Instrument (CASI) on weeks 0, 12, 24, and 49.

4. Instrumental Activities of Daily Living (IADL) [weeks 0,12, 24, and 49]

   Assess changes of Instrumental Activities of Daily Living (IADL) on weeks 0, 12, 24, and 49.

5. Dehydroepiandrosterone sulfate (DHEAS) [weeks 0, 24, and 49]

   Assess changes of DHEAS on weeks 0, 24, and 49.

6. Alpha 1-antichymotrypsin [weeks 0, 24, and 49]

   Assess changes of Alpha 1-antichymotrypsinon weeks 0, 24, and 49.

7. Superoxide Dismutase [weeks 0, 24, and 49]

   Assess changes of Superoxide Dismutase on weeks 0, 24, and 49.

8. Homocysteine [weeks 0, 24, and 49]

   Assess changes of Homocysteine on weeks 0, 24, and 49.

9. Apolipoprotein E [weeks 0, 24, and 49]

   Assess changes of Apolipoprotein E on weeks 0, 24, and 49.

10. Hemoglobin [weeks 0, 24, and 49]

    Assess changes of Hemoglobin on weeks 0, 24, and 49.

11. Calcium [weeks 0, 24, and 49]

    Assess changes of Calcium on weeks 0, 24, and 49.

12. Albumin [weeks 0, 24, and 49]

    Assess changes of Albumin on weeks 0, 24, and 49.

13. Amyloid Beta [weeks 0, 24, and 49]

    Assess changes of Amyloid Beta on weeks 0, 24, and 49.

14. fMRI-Super-resolution Track Density Imaging (TDI) [weeks 0 and 49]

    Assess changes of Super-resolution Track Density Imaging (TDI) on weeks 0 and 49.

15. fMRI-Blood Oxygenation Level-Dependent (BOLD) Signal Mapping [weeks 0 and 49]

    Assess changes of Blood Oxygenation Level-Dependent (BOLD) Signal Mapping, on weeks 0 and 49.

16. Vision Assessments-Visual Acuity (VA) [weeks 0, 24, and 49]

    Assess changes of Visual Acuity (VA) on weeks 0, 24, and 49.

17. Vision Assessments-Contrast Sensitivity (CS) [weeks 0, 24, and 49]

    Assess changes of Contrast Sensitivity (CS) on weeks 0, 24, and 49.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chung Shan Medical University Hospital	Taichung		Taiwan	40201

Sponsors and Collaborators

• Chung Shan Medical University
• Grape King Bio Ltd.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: David Pei-Cheng Lin, Professor, Chung Shan Medical University
• ClinicalTrials.gov Identifier: NCT04065061
• Other Study ID Numbers: CS15049
• First Posted: Aug 22, 2019
• Last Update Posted: Aug 22, 2019
• Last Verified: Aug 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by David Pei-Cheng Lin, Professor, Chung Shan Medical University: Erinacine A, supplement, Alzheimer's disease
• Additional relevant MeSH terms: Cognition Disorders

Study Results

No Results Posted as of Aug 22, 2019