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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
68
Placebo supplement was given to the participants.
Chung Shan Medical University Hospital
Taichung, Taiwan
Mini-Mental State Examination(MMSE)
Assess changes of Mini-Mental State Examination(MMSE) on weeks 0, 12, 24, and 49.
Time frame: weeks 0,12, 24, and 49
Neuropsychiatric Inventory (NPI)
Assess changes of Neuropsychiatric Inventory (NPI) on weeks 0, 12, 24, and 49.
Time frame: 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.
Time frame: 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.
Time frame: weeks 0,12, 24, and 49
Dehydroepiandrosterone sulfate (DHEAS)
Assess changes of DHEAS on weeks 0, 24, and 49.
Time frame: weeks 0, 24, and 49
Alpha 1-antichymotrypsin
Assess changes of Alpha 1-antichymotrypsinon weeks 0, 24, and 49.
Time frame: weeks 0, 24, and 49
Superoxide Dismutase
Assess changes of Superoxide Dismutase on weeks 0, 24, and 49.
Time frame: weeks 0, 24, and 49
Homocysteine
Assess changes of Homocysteine on weeks 0, 24, and 49.
Time frame: weeks 0, 24, and 49
Apolipoprotein E
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Assess changes of Apolipoprotein E on weeks 0, 24, and 49.
Time frame: weeks 0, 24, and 49
Hemoglobin
Assess changes of Hemoglobin on weeks 0, 24, and 49.
Time frame: weeks 0, 24, and 49
Calcium
Assess changes of Calcium on weeks 0, 24, and 49.
Time frame: weeks 0, 24, and 49
Albumin
Assess changes of Albumin on weeks 0, 24, and 49.
Time frame: weeks 0, 24, and 49
Amyloid Beta
Assess changes of Amyloid Beta on weeks 0, 24, and 49.
Time frame: 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.
Time frame: 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.
Time frame: weeks 0 and 49
Vision Assessments-Visual Acuity (VA)
Assess changes of Visual Acuity (VA) on weeks 0, 24, and 49.
Time frame: weeks 0, 24, and 49
Vision Assessments-Contrast Sensitivity (CS)
Assess changes of Contrast Sensitivity (CS) on weeks 0, 24, and 49.
Time frame: weeks 0, 24, and 49