NCT04428983

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P75+ for not_applicable parkinson-disease

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

February 3, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2023

Completed
Last Updated

June 11, 2020

Status Verified

June 1, 2020

Enrollment Period

2.1 years

First QC Date

November 20, 2019

Last Update Submit

June 9, 2020

Conditions

Parkinson Disease

Keywords

Parkinson Disease, non-motor symptoms

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (2)

Hericium erinaceus mycelium

EXPERIMENTAL

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

Dietary Supplement: Hericium erinaceus mycelium

placebo

PLACEBO COMPARATOR

placebo capsules 1 table tid orally per day for 24 months

Dietary Supplement: Hericium erinaceus mycelium

Interventions

Hericium erinaceus myceliumDIETARY_SUPPLEMENT

Hericium erinaceus capsules 3 tables per day for 24 months

Hericium erinaceus myceliumplacebo

Eligibility Criteria

Age50 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cheng Kung University Hospital

Tainan, 704, Taiwan

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Li-Ya Lee

    Bioengineering Center, Grape King Bio

    STUDY DIRECTOR

Central Study Contacts

Li-Ya Lee

CONTACT

+886-3-4572525ly.lee@grapeking.com.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

November 20, 2019

First Posted

June 11, 2020

Study Start

February 3, 2020

Primary Completion

March 20, 2022

Study Completion

March 20, 2023

Last Updated

June 11, 2020

Record last verified: 2020-06

Locations

TW(1)