Advances in clinical trial design methodology for prodromal Parkinson disease
10.19845/j.cnki.zfysjjbzz.2024.0190
- VernacularTitle:帕金森病前驱期临床试验设计方法学的研究进展
- Author:
Yake ZHANG
1
;
Shun WANG
;
Yulin WANG
Author Information
1. 黑龙江中医药大学研究生院,黑龙江 哈尔滨 150000
- Keywords:
Parkinson disease;
Prodromal Parkinson disease;
Clinical trial design;
Strategy selection
- From:
Journal of Apoplexy and Nervous Diseases
2024;41(11):999-1003
- CountryChina
- Language:Chinese
-
Abstract:
The neuropathic damage of Parkinson disease(PD)is irreversible.In recent years,advances in PD re-search frontiers have found that decades before the typical motor symptoms of PD,some pathological changes already hap-pen.This interval prior to diagnosis,or the prodromal phase of PD,is an excellent window for neuroprotective therapy re-search,and this type of research may create a breakthrough in developing effective treatment for PD,reducing the inci-dence of PD,and delaying the progression of PD.This review on prodromal PD-related literature summarizes current clini-cal research design methods,and discusses the decision-making around clinical trial design with regard to study popula-tion,sample size,outcome indicators,safety,and subject diaries,aiming to provide a reference for the design of clinical trials of prodromal PD.
