The Effect of Hericium Erinaceus Mycelium in Non-motor Symptoms of Parkinson's Disease
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:
- 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:
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
- 否
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
Yuan-Ting Sun
Doctor
National Cheng-Kung University Hospital
