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

Chung Shan Medical University2 sites in 1 country68 target enrollmentStarted: May 22, 2015Last updated: August 22, 2019

Conditions

Interventions

Trial Snapshot

Phase: Not Applicable
Status: Completed
Sponsor: Chung Shan Medical University
Enrollment: 68
Locations: 2
Primary Endpoint: Neuropsychiatric Inventory (NPI)

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

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.

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel
Primary Purpose: Other
Masking: Triple (Participant, Care Provider, Investigator)

Masking Description

to be completed

Eligibility Criteria

Ages: 50 Years to 90 Years (Adult, Older Adult)
Sex: 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

Arms & Interventions

Placebo

Placebo Comparator

Placebo dietary supplement from week 0 to week 49.

Intervention: Placebo (Dietary Supplement)

Experimental

Erinacine A-enriched Hericium Erinaceus Mycelia dietary supplement from week 0 to week 49.

Intervention: Erinacine A-enriched Hericium Erinaceus Mycelia (Dietary Supplement)

Outcomes

Primary Outcomes

Neuropsychiatric Inventory (NPI)

Time Frame: weeks 0,12, 24, and 49

Assess changes of Neuropsychiatric Inventory (NPI) on 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.

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.

Albumin