fMRI Clinical Trial
Official title:
Investigation of Erinacine A-enriched Hericium Erinaceus Mycelia for Improvement of Recognition, Vision, and Functional MRI Alterations
NCT number | NCT04065061 |
Other study ID # | CS15049 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 22, 2015 |
Est. completion date | May 10, 2017 |
Verified date | August 2019 |
Source | Chung Shan Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 68 |
Est. completion date | May 10, 2017 |
Est. primary completion date | May 10, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 90 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Taiwan | Chung Shan Medical University Hospital | Taichung |
Lead Sponsor | Collaborator |
---|---|
Chung Shan Medical University | Grape King Bio Ltd. |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mini-Mental State Examination(MMSE) | Assess changes of Mini-Mental State Examination(MMSE) on weeks 0, 12, 24, and 49. | weeks 0,12, 24, and 49 | |
Primary | Neuropsychiatric Inventory (NPI) | Assess changes of Neuropsychiatric Inventory (NPI) on weeks 0, 12, 24, and 49. | weeks 0,12, 24, and 49 | |
Primary | Cognitive Abilities Screening Instrument (CASI) | Assess changes of Cognitive Abilities Screening Instrument (CASI) on weeks 0, 12, 24, and 49. | weeks 0,12, 24, and 49 | |
Primary | Instrumental Activities of Daily Living (IADL) | Assess changes of Instrumental Activities of Daily Living (IADL) on weeks 0, 12, 24, and 49. | weeks 0,12, 24, and 49 | |
Primary | Dehydroepiandrosterone sulfate (DHEAS) | Assess changes of DHEAS on weeks 0, 24, and 49. | weeks 0, 24, and 49 | |
Primary | Alpha 1-antichymotrypsin | Assess changes of Alpha 1-antichymotrypsinon weeks 0, 24, and 49. | weeks 0, 24, and 49 | |
Primary | Superoxide Dismutase | Assess changes of Superoxide Dismutase on weeks 0, 24, and 49. | weeks 0, 24, and 49 | |
Primary | Homocysteine | Assess changes of Homocysteine on weeks 0, 24, and 49. | weeks 0, 24, and 49 | |
Primary | Apolipoprotein E | Assess changes of Apolipoprotein E on weeks 0, 24, and 49. | weeks 0, 24, and 49 | |
Primary | Hemoglobin | Assess changes of Hemoglobin on weeks 0, 24, and 49. | weeks 0, 24, and 49 | |
Primary | Calcium | Assess changes of Calcium on weeks 0, 24, and 49. | weeks 0, 24, and 49 | |
Primary | Albumin | Assess changes of Albumin on weeks 0, 24, and 49. | weeks 0, 24, and 49 | |
Primary | Amyloid Beta | Assess changes of Amyloid Beta on weeks 0, 24, and 49. | weeks 0, 24, and 49 | |
Primary | fMRI-Super-resolution Track Density Imaging (TDI) | Assess changes of Super-resolution Track Density Imaging (TDI) on weeks 0 and 49. | weeks 0 and 49 | |
Primary | fMRI-Blood Oxygenation Level-Dependent (BOLD) Signal Mapping | Assess changes of Blood Oxygenation Level-Dependent (BOLD) Signal Mapping, on weeks 0 and 49. | weeks 0 and 49 | |
Primary | Vision Assessments-Visual Acuity (VA) | Assess changes of Visual Acuity (VA) on weeks 0, 24, and 49. | weeks 0, 24, and 49 | |
Primary | Vision Assessments-Contrast Sensitivity (CS) | Assess changes of Contrast Sensitivity (CS) on weeks 0, 24, and 49. | weeks 0, 24, and 49 |
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