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

Not Applicable

• Conditions: Parkinson Disease
• Interventions: Dietary Supplement: Hericium erinaceus mycelium

• Registration Number: NCT04428983
• Lead Sponsor: 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.

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

Study Timeline

• Study First Submitted: 2019-11-20
• Study Start: 2020-02-03
• Status Verified: 2020-06
• Study First Submitted QC: 2020-06-09
• Last Update Submitted: 2020-06-09
• Study First Posted: 2020-06-11
• Last Update Posted: 2020-06-11
• Primary Completion: 2022-03-20
• Study Completion: 2023-03-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hericium erinaceus mycelium	Hericium erinaceus mycelium	Hericium erinaceus capsules 1 table tid orally per day for 24 months
placebo	Hericium erinaceus mycelium	placebo capsules 1 table tid orally per day for 24 months

Primary Outcome Measures

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

Trial Locations

Locations (1)

National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan