AI-based Progression and Medication Response Prediction Study in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Classification performance of the Parkinson's disease (PD) progression prediction model
研究概览
简要总结
The study aims to provide initial PoC validation data of two AI models to predict disease progression and treatment side effects in PD patients using as input patients' demographic, clinical and genetic information, as well as digital biomarker measurements in daily living collected via a smartwatch and a mobile application.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parkinson's disease diagnosis according to MDS criteria (Postuma et al., 2015)
- •Disease duration ranging from 5 to 10 years
- •Age 40-80
- •Patients in stages 2 and 3 of the Hoehn and Yahr (a functional disability scale) in the ON condition
- •The participant is using a compatible smartphone
- •Written informed consent
排除标准
- •Atypical Parkinsonian Syndrome
- •Second-line device-aided treatments
- •Patients with >4 daily doses of L-DOPA
- •Daily levodopa equivalent dose > 1500 mg
- •Ongoing hallucinations requiring short-term treatment adjustment
- •Inability to provide informed consent or participate in the study
- •Inability to use the smartwatch and/or the mAI-Care app - as judged by investigator
- •Lacking motivation to participate in study procedures - as judged by investigator
- •Under adult autonomy protection system, legal guardianship or incapacitation
- •Pregnant and breast-feeding women
结局指标
主要结局
Classification performance of the Parkinson's disease (PD) progression prediction model
时间窗: Between baseline and 12 months
Classification performance of the model in predicting observed motor disease progression, defined as a binary outcome: the condition of a patient is classified as worsened if either the Movement Disorder Society Unified Parkinson's Disease (MDS-UPDRS) rating scale part III score in ON-state increases by more than 3 points (\>3), or the Levodopa Equivalent Daily Dose (LEDD) increases by more than 10%.
次要结局
- Usability of the mAI-Care app(12 month visit)
- Usability of the mAI-Insights app(12 month visit)