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Completed

NCT Number: NCT04065061

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

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.

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Key information

Conditions

Supplement Alzheimer Disease Brain Diseases Central Nervous System Diseases Cognition Disorders in Old Age Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies Vision fMRI

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chung Shan Medical University Hospital

Taichung, 40201, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Erinacine A-enriched Hericium Erinaceus Mycelia

Dietary Supplement

Placebo

Dietary Supplement

Placebo supplement was given to the participants.

Primary outcomes

  1. Mini-Mental State Examination(MMSE)

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

    Assess changes of Mini-Mental State Examination(MMSE) on weeks 0, 12, 24, and 49.

  2. Neuropsychiatric Inventory (NPI)

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

    Assess changes of Neuropsychiatric Inventory (NPI) on weeks 0, 12, 24, and 49.

  3. 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.

  4. 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.

  5. Dehydroepiandrosterone sulfate (DHEAS)

    Time frame: weeks 0, 24, and 49

    Assess changes of DHEAS on weeks 0, 24, and 49.

  6. Alpha 1-antichymotrypsin

    Time frame: weeks 0, 24, and 49

    Assess changes of Alpha 1-antichymotrypsinon weeks 0, 24, and 49.

  7. Superoxide Dismutase

    Time frame: weeks 0, 24, and 49

    Assess changes of Superoxide Dismutase on weeks 0, 24, and 49.

  8. Homocysteine

    Time frame: weeks 0, 24, and 49

    Assess changes of Homocysteine on weeks 0, 24, and 49.

  9. Apolipoprotein E

    Time frame: weeks 0, 24, and 49

    Assess changes of Apolipoprotein E on weeks 0, 24, and 49.

  10. Hemoglobin

    Time frame: weeks 0, 24, and 49

    Assess changes of Hemoglobin on weeks 0, 24, and 49.

  11. Calcium

    Time frame: weeks 0, 24, and 49

    Assess changes of Calcium on weeks 0, 24, and 49.

  12. Albumin

    Time frame: weeks 0, 24, and 49

    Assess changes of Albumin on weeks 0, 24, and 49.

  13. Amyloid Beta

    Time frame: weeks 0, 24, and 49

    Assess changes of Amyloid Beta on weeks 0, 24, and 49.

  14. fMRI-Super-resolution Track Density Imaging (TDI)

    Time frame: weeks 0 and 49

    Assess changes of Super-resolution Track Density Imaging (TDI) on weeks 0 and 49.

  15. fMRI-Blood Oxygenation Level-Dependent (BOLD) Signal Mapping

    Time frame: weeks 0 and 49

    Assess changes of Blood Oxygenation Level-Dependent (BOLD) Signal Mapping, on weeks 0 and 49.

  16. Vision Assessments-Visual Acuity (VA)

    Time frame: weeks 0, 24, and 49

    Assess changes of Visual Acuity (VA) on weeks 0, 24, and 49.

  17. Vision Assessments-Contrast Sensitivity (CS)

    Time frame: weeks 0, 24, and 49

    Assess changes of Contrast Sensitivity (CS) on weeks 0, 24, and 49.

Sponsors and collaborators

Lead sponsor

Chung Shan Medical University

Other

Collaborators

  • Grape King Bio Ltd.

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Aug 22, 2019
Registry last updated
Aug 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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