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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Supplement, Cognition Disorders in Old Age, Vision, fMRI

Intervention / Treatment
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* Dietary Supplement: Erinacine A-enriched Hericium Erinaceus Mycelia
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Double Blinded placebo study
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Neuropsychiatric Inventory (NPI) | Assess changes of Neuropsychiatric Inventory (NPI) on weeks 0, 12, 24, and 49. | 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. | 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. | weeks 0,12, 24, and 49 | 
| Dehydroepiandrosterone sulfate (DHEAS) | Assess changes of DHEAS on weeks 0, 24, and 49. | weeks 0, 24, and 49 | 
| Alpha 1-antichymotrypsin | Assess changes of Alpha 1-antichymotrypsinon weeks 0, 24, and 49. | weeks 0, 24, and 49 | 
| Superoxide Dismutase | Assess changes of Superoxide Dismutase on weeks 0, 24, and 49. | weeks 0, 24, and 49 | 
| Homocysteine | Assess changes of Homocysteine on weeks 0, 24, and 49. | weeks 0, 24, and 49 | 
| Apolipoprotein E | Assess changes of Apolipoprotein E on weeks 0, 24, and 49. | weeks 0, 24, and 49 | 
| Hemoglobin | Assess changes of Hemoglobin on weeks 0, 24, and 49. | weeks 0, 24, and 49 | 
| Calcium | Assess changes of Calcium on weeks 0, 24, and 49. | weeks 0, 24, and 49 | 
| Albumin | Assess changes of Albumin on weeks 0, 24, and 49. | weeks 0, 24, and 49 | 
| Amyloid Beta | Assess changes of Amyloid Beta on weeks 0, 24, and 49. | 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. | 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. | weeks 0 and 49 | 
| Vision Assessments-Visual Acuity (VA) | Assess changes of Visual Acuity (VA) on weeks 0, 24, and 49. | weeks 0, 24, and 49 | 
| Vision Assessments-Contrast Sensitivity (CS) | Assess changes of Contrast Sensitivity (CS) on weeks 0, 24, and 49. | weeks 0, 24, and 49 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Erinacine A, supplement, Alzheimer's disease