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

Study Overview
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Brief Summary
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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.

Detailed Description
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Inclusion criteria: 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) PD at Hoehn and Yahr stage 2-2.5 without cognitive decline Exclusion criteria: with diabetes mellitus (DM) with nephropathy (GFR < 30ml/min) with significant neurological deficits caused by vascular insults Measurement parameters: At recruitment: blood sugar, AST, ALT, BUN, Crea, Ca, Na, K and peripheral blood cell (for the expression levels of KATP) 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 every 1 year: CASI, tilting table, AST, ALT, BUN, crea, Na, K, Ca Protocol: 0 month (initial baseline): blood sugar, AST, ALT, BUN, Crea, Ca, Na, K and peripheral blood cell Tilting table test (autonomic function) CASI cognitive test UPDRS, evaluate with UDYSRS if presence with dyskinesia Non motor symptoms: self-report: PDQ39, QUIP, PDSS Rated by neurologist: NMSS, HAM-D, BPRS 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: UPDRS, evaluate with UDYSRS if presence with dyskinesia Non motor symptoms: self-report: PDQ39, QUIP, PDSS Rated by neurologist: NMSS, HAM-D, BPRS 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: UPDRS, evaluate with UDYSRS if presence with dyskinesia Non motor symptoms: self-report: PDQ39, QUIP, PDSS Rated by neurologist: NMSS, HAM-D, BPRS CASI cognitive test, tilting table, AST, ALT, BUN, crea, Na, K, Ca stool microbiota

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

Conditions
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Parkinson Disease

Intervention / Treatment
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* Dietary Supplement: Hericium erinaceus mycelium


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hericium erinaceus mycelium<br>Hericium erinaceus capsules 1 table tid orally per day for 24 months | Dietary Supplement: Hericium erinaceus mycelium<br>* Hericium erinaceus capsules 3 tables per day for 24 months<br>|
| Placebo Comparator: placebo<br>placebo capsules 1 table tid orally per day for 24 months | Dietary Supplement: Hericium erinaceus mycelium<br>* Hericium erinaceus capsules 3 tables per day for 24 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| baseline | Unified Parkinson's Disease Rating Scale (MDS-UPDRS) | 0 month | 
| 1st | Unified Parkinson's Disease Rating Scale (MDS-UPDRS) | 6 momths | 
| 2nd | Unified Parkinson's Disease Rating Scale (MDS-UPDRS) | 12 months | 
| 3rd | UPDRS | 18 months | 
| final | Unified Parkinson's Disease Rating Scale (MDS-UPDRS) | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson Disease, non-motor symptoms