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临床试验/NCT04428983
NCT04428983Unknown不适用

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

National Cheng-Kung University Hospital2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年2月3日最近更新:
适应症

试验速览

阶段
不适用
入组人数
80
试验地点
2
主要终点
baseline

研究概览

简要总结

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.

详细描述

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:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
50 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

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

结局指标

主要结局

baseline

时间窗: 0 month

Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

1st

时间窗: 6 momths

Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

2nd

时间窗: 12 months

Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

3rd

时间窗: 18 months

UPDRS

final

时间窗: 24 months

Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yuan-Ting Sun

Doctor

National Cheng-Kung University Hospital

研究点 (2)

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