NCT04065061

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Chung Shan Medical University · Academic / Other
• Sex: All
• Age: 50 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Supplement
• Cognition Disorders in Old Age
• Vision
• fMRI

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Erinacine A-enriched Hericium Erinaceus Mycelia
DIETARY_SUPPLEMENT	Placebo	Placebo supplement was given to the participants.

Timeline

• Start date: 2015-05-22
• Primary completion: 2016-05-10
• Completion: 2017-05-10
• First posted: 2019-08-22
• Last updated: 2019-08-22

Locations

1 site across 1 country: Taiwan