Clinical trial NCT04065061: Erinacine A-enriched Hericium Erinaceus Mycelia for Improvement of Recognition, Vision, and Functional MRI Alterations
Official title: Investigation of Erinacine A-enriched Hericium Erinaceus Mycelia for Improvement of Recognition, Vision, and Functional MRI Alterations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Supplement
Cognition Disorders in Old Age
Vision
fMRI
Keywords: Erinacine A, supplement, Alzheimer's disease
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
Collaborators: name: Grape King Bio Ltd.
First posted: 2019-08-22
Enrollment: 68
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Double Blinded placebo study
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mini-Mental State Examination(MMSE)
timeFrame: weeks 0,12, 24, and 49
measure: Neuropsychiatric Inventory (NPI)
timeFrame: weeks 0,12, 24, and 49
measure: Cognitive Abilities Screening Instrument (CASI)
timeFrame: weeks 0,12, 24, and 49
measure: Instrumental Activities of Daily Living (IADL)
timeFrame: weeks 0,12, 24, and 49
measure: Dehydroepiandrosterone sulfate (DHEAS)
timeFrame: weeks 0, 24, and 49
measure: Alpha 1-antichymotrypsin
timeFrame: weeks 0, 24, and 49
measure: Superoxide Dismutase
timeFrame: weeks 0, 24, and 49
measure: Homocysteine
timeFrame: weeks 0, 24, and 49
measure: Apolipoprotein E
timeFrame: weeks 0, 24, and 49
measure: Hemoglobin
timeFrame: weeks 0, 24, and 49
measure: Calcium
timeFrame: weeks 0, 24, and 49
measure: Albumin
timeFrame: weeks 0, 24, and 49
measure: Amyloid Beta
timeFrame: weeks 0, 24, and 49
measure: fMRI-Super-resolution Track Density Imaging (TDI)
timeFrame: weeks 0 and 49
measure: fMRI-Blood Oxygenation Level-Dependent (BOLD) Signal Mapping
timeFrame: weeks 0 and 49
measure: Vision Assessments-Visual Acuity (VA)
timeFrame: weeks 0, 24, and 49
measure: Vision Assessments-Contrast Sensitivity (CS)
timeFrame: weeks 0, 24, and 49
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
Study officials:
affiliation: Chung Shan Medical University
name: David Pei-Cheng Lin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li IC, Chang HH, Lin CH, Chen WP, Lu TH, Lee LY, Chen YW, Chen YP, Chen CC, Lin DP. Prevention of Early Alzheimer's Disease by Erinacine A-Enriched Hericium erinaceus Mycelia Pilot Double-Blind Placebo-Controlled Study. Front Aging Neurosci. 2020 Jun 3;12:155. doi: 10.3389/fnagi.2020.00155. eCollection 2020.