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The Effect of Hericium Erinaceus Mycelium in Non-motor Symptoms of Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT04428983
Recruitment Status : Recruiting
First Posted : June 11, 2020
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
Yuan-Ting Sun, National Cheng-Kung University Hospital

Brief Summary:
Parkinson disease (PD) is considered a multisystemic neurodegenerative disorder, together with the classic motor disability, and a number of non-motor symptoms (NMS).NMS have a significant negative relation with patients' quality of life. In general, both medicinal and nonmedicinal therapies are often advised for PD patients with NMS, but robust evidences for underpinning the clinical effects are limited. Recently, the search for small preventative neurotrophic compounds that are responsible for the maintenance, survival of neurons has attracted much attention. Erinacine A, which is extracted from Hericium erinaceus is the one showed prominent beneficial effects in the central nervous system. It can increase NGF and catecholamine content in the locus coeruleus and hippocampus of rats. This markedly increases neuronal survival in different brain areas and substantially improve behavioral outcomes in various animal models. In a MPTP-induced Parkinsonism model, treatment with Hericium erinaceus mycelium reduced the loss of dopaminergic cell, eliminated neuronal apoptosis and reversed MPTP-associated motor deficits. Thus, this project intends to hold a randomized, controlled trial to assess the effect of Hericium erinaceus mycelium, which is enriched of Erinacine A, in NMS of PD. This project will enroll 80 patients with PD. Subjects will be randomly allocated into study or placebo group. Subjects will take Hericium erinaceus mycelium for 2 years (one capsule per meal per day) and their treatments for PD will not be altered.

Condition or disease Intervention/treatment Phase
Parkinson Disease Dietary Supplement: Hericium erinaceus mycelium Not Applicable

Detailed Description:

Inclusion criteria:

  1. PD patients aged 50-79 years diagnosed by neurologist (should exclude vascular parkinsonism, secondary parkinsonism( including toxin, drug, heavy metal, CO intoxication), normal pressure hydrocephalus, multiple system atrophy, progressive supranuclear palsy, cortical basal degeneration, dementia with Lewy Body, hereditary parkinson's disease with genetic mutation, Huntington's disease, Wilson disease, spinal cerebellar ataxia with extrapyramidal syndrome, essential tremor, dystonia)
  2. PD at Hoehn and Yahr stage 2-2.5
  3. without cognitive decline

Exclusion criteria:

  1. with diabetes mellitus (DM)
  2. with nephropathy (GFR < 30ml/min)
  3. with significant neurological deficits caused by vascular insults

Measurement parameters:

  1. At recruitment: blood sugar, AST, ALT, BUN, Crea, Ca, Na, K and peripheral blood cell (for the expression levels of KATP)
  2. every 6 months: motor symptoms: UPDRS, evaluate with UDYSRS if presence with dyskinesia Non motor symptoms: self-report: PDQ39, QUIP, PDSS Rated by neurologist: NMSS, HAM-D, BPRS
  3. every 1 year: CASI, tilting table, AST, ALT, BUN, crea, Na, K, Ca

Protocol:

0 month (initial baseline):

  1. blood sugar, AST, ALT, BUN, Crea, Ca, Na, K and peripheral blood cell
  2. Tilting table test (autonomic function)
  3. CASI cognitive test
  4. UPDRS, evaluate with UDYSRS if presence with dyskinesia Non motor symptoms: self-report: PDQ39, QUIP, PDSS Rated by neurologist: NMSS, HAM-D, BPRS
  5. stool microbiota

6 months: UPDRS, evaluate with UDYSRS if presence with dyskinesia Non motor symptoms: self-report: PDQ39, QUIP, PDSS Rated by neurologist: NMSS, HAM-D, BPRS

12 months:

  1. UPDRS, evaluate with UDYSRS if presence with dyskinesia Non motor symptoms: self-report: PDQ39, QUIP, PDSS Rated by neurologist: NMSS, HAM-D, BPRS
  2. CASI cognitive test, tilting table, AST, ALT, BUN, crea, Na, K, Ca

18 months: UPDRS, evaluate with UDYSRS if presence with dyskinesia Non motor symptoms: self-report: PDQ39, QUIP, PDSS Rated by neurologist: NMSS, HAM-D, BPRS

24 months:

  1. UPDRS, evaluate with UDYSRS if presence with dyskinesia Non motor symptoms: self-report: PDQ39, QUIP, PDSS Rated by neurologist: NMSS, HAM-D, BPRS
  2. CASI cognitive test, tilting table, AST, ALT, BUN, crea, Na, K, Ca
  3. stool microbiota

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: The Effect of Hericium Erinaceus Mycelium in Non-motor Symptoms of Parkinson's Disease
Actual Study Start Date : February 3, 2020
Estimated Primary Completion Date : March 20, 2022
Estimated Study Completion Date : March 20, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hericium erinaceus mycelium
Hericium erinaceus capsules 1 table tid orally per day for 24 months
Dietary Supplement: Hericium erinaceus mycelium
Hericium erinaceus capsules 3 tables per day for 24 months

Placebo Comparator: placebo
placebo capsules 1 table tid orally per day for 24 months
Dietary Supplement: Hericium erinaceus mycelium
Hericium erinaceus capsules 3 tables per day for 24 months




Primary Outcome Measures :
  1. baseline [ Time Frame: 0 month ]
    Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

  2. 1st [ Time Frame: 6 momths ]
    Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

  3. 2nd [ Time Frame: 12 months ]
    Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

  4. 3rd [ Time Frame: 18 months ]
    UPDRS

  5. final [ Time Frame: 24 months ]
    Unified Parkinson's Disease Rating Scale (MDS-UPDRS)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • idiopathic PD patients, aged 50-79 years
  • modified Hoehn & Yahr stage 2-2.5
  • Without subjective and objective cognitive decline (objective cognitive decline will be determined by CASI)

Exclusion Criteria:

  • With diabetes
  • With end stage renal disease under hemodialysis
  • With significant vascular insults that resulted in significant neurological deficits

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04428983


Contacts
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Contact: Li-Ya Lee +886-3-4572525 ext 2995 ly.lee@grapeking.com.tw

Locations
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Taiwan
National Cheng Kung University Hospital Recruiting
Tainan, Taiwan, 704
Contact: Yuan-Ting Sun, MD PhD    +886-6-2353535    ytsun@mail.ncku.edu.tw   
Sponsors and Collaborators
National Cheng-Kung University Hospital
Investigators
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Study Director: Li-Ya Lee Bioengineering Center, Grape King Bio
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Responsible Party: Yuan-Ting Sun, Doctor, National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier: NCT04428983    
Other Study ID Numbers: HELPD V4 20191120
First Posted: June 11, 2020    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yuan-Ting Sun, National Cheng-Kung University Hospital:
Parkinson Disease, non-motor symptoms
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases