Investigation of Erinacine A-enriched Hericium Erinaceus Mycelia for Improvement of Recognition, Vision, and Functional MRI Alterations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Neuropsychiatric Inventory (NPI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
to be completed
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •vulnerable to injuries
- •loss of self-recognition,
- •loss of behavioral capacity
- •with critical illness
- •with major diseases
研究组 & 干预措施
Placebo
Placebo dietary supplement from week 0 to week 49.
干预措施: Placebo (Dietary Supplement)
Experimental
Erinacine A-enriched Hericium Erinaceus Mycelia dietary supplement from week 0 to week 49.
干预措施: Erinacine A-enriched Hericium Erinaceus Mycelia (Dietary Supplement)
结局指标
主要结局
Neuropsychiatric Inventory (NPI)
时间窗: 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)
时间窗: 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)
时间窗: weeks 0,12, 24, and 49
Assess changes of Cognitive Abilities Screening Instrument (CASI) on weeks 0, 12, 24, and 49.
Albumin
时间窗: weeks 0, 24, and 49
Assess changes of Albumin on weeks 0, 24, and 49.
Amyloid Beta
时间窗: weeks 0, 24, and 49
Assess changes of Amyloid Beta on weeks 0, 24, and 49.
Mini-Mental State Examination(MMSE)
时间窗: weeks 0,12, 24, and 49
Assess changes of Mini-Mental State Examination(MMSE) on weeks 0, 12, 24, and 49.
Dehydroepiandrosterone sulfate (DHEAS)
时间窗: weeks 0, 24, and 49
Assess changes of DHEAS on weeks 0, 24, and 49.
Apolipoprotein E
时间窗: weeks 0, 24, and 49
Assess changes of Apolipoprotein E on weeks 0, 24, and 49.
Homocysteine
时间窗: weeks 0, 24, and 49
Assess changes of Homocysteine on weeks 0, 24, and 49.
Calcium
时间窗: weeks 0, 24, and 49
Assess changes of Calcium on weeks 0, 24, and 49.
fMRI-Super-resolution Track Density Imaging (TDI)
时间窗: weeks 0 and 49
Assess changes of Super-resolution Track Density Imaging (TDI) on weeks 0 and 49.
Alpha 1-antichymotrypsin
时间窗: weeks 0, 24, and 49
Assess changes of Alpha 1-antichymotrypsinon weeks 0, 24, and 49.
Superoxide Dismutase
时间窗: weeks 0, 24, and 49
Assess changes of Superoxide Dismutase on weeks 0, 24, and 49.
Hemoglobin
时间窗: weeks 0, 24, and 49
Assess changes of Hemoglobin on weeks 0, 24, and 49.
fMRI-Blood Oxygenation Level-Dependent (BOLD) Signal Mapping
时间窗: weeks 0 and 49
Assess changes of Blood Oxygenation Level-Dependent (BOLD) Signal Mapping, on weeks 0 and 49.
Vision Assessments-Visual Acuity (VA)
时间窗: weeks 0, 24, and 49
Assess changes of Visual Acuity (VA) on weeks 0, 24, and 49.
Vision Assessments-Contrast Sensitivity (CS)
时间窗: weeks 0, 24, and 49
Assess changes of Contrast Sensitivity (CS) on weeks 0, 24, and 49.
次要结局
未报告次要终点
研究者
David Pei-Cheng Lin
Professor
Chung Shan Medical University