Trial | NCT04428983  Report issue

Official Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    80
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.
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
Study Started
Feb 03
2020
Primary Completion
Mar 20
2022
Anticipated
Study Completion
Mar 20
2023
Anticipated
Last Update
Jun 11
2020

Dietary Supplement Hericium erinaceus mycelium

Hericium erinaceus capsules 3 tables per day for 24 months

Hericium erinaceus mycelium Experimental

Hericium erinaceus capsules 1 table tid orally per day for 24 months

placebo Placebo Comparator

placebo capsules 1 table tid orally per day for 24 months

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
No Results Posted