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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04428983
Enrollment
80
Registered
2020-06-11
Start date
2020-02-03
Completion date
2023-03-20
Last updated
2020-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Keywords

Parkinson Disease, non-motor symptoms

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

Interventions

DIETARY_SUPPLEMENTHericium erinaceus mycelium

Hericium erinaceus capsules 3 tables per day for 24 months

Sponsors

National Cheng-Kung University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
50 Years to 79 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
baseline0 monthUnified Parkinson's Disease Rating Scale (MDS-UPDRS)
1st6 momthsUnified Parkinson's Disease Rating Scale (MDS-UPDRS)
2nd12 monthsUnified Parkinson's Disease Rating Scale (MDS-UPDRS)
3rd18 monthsUPDRS
final24 monthsUnified Parkinson's Disease Rating Scale (MDS-UPDRS)

Countries

Taiwan

Contacts

Primary ContactLi-Ya Lee
ly.lee@grapeking.com.tw+886-3-4572525

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026