MotOr, cogniTIVe and Imaging charactErization of Progressive Supranuclear Palsy Phenotypes: a Longitudinal Prospective Study Looking for Biomarkers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 165
- 试验地点
- 3
- 主要终点
- Progressive Supranuclear Palsy rating scale
研究概览
简要总结
Progressive Supranuclear Palsy (PSP) is a rapidly progressive neurodegenerative disease characterized by falls and oculomotor disturbances. Several clinical trials are currently evaluating the efficacy of new pharmacological compounds in slowing disease progression. Yet, both early diagnosis and evaluation of disease progression remain challenging.
Study aims include verifying if specific motor, cognitive, language, cerebrospinal fluid and imaging assessments represent reliable biomarkers of PSP diagnosis, phenotypization and progression over 1-year follow up. Motor evaluation will include recordings from wearable sensors.
Expected results include 1) improvement of PSP diagnosis and phenotypization; 2)improvement of evaluation of disease progression in the context of clinical trial; 3)enhancement of strategies to prevent falls and fractures in such patients leading, in turn, to significant cost savings for the National Health System.
详细描述
Hyphotesis and Significance:
1)Cross-sectional phase:verify if specific motor, cognitive, language, cerebrospinal fluid (CSF) and imaging assessments represent reliable biomarkers of diagnosis in PSP in the earliest stages of disease compared to Parkinson's disease (PD) and healthy controls (HC) and are able characterize the different PSP clinical phenotype 2)12-month longitudinal phase:verify if specific motor, cognitive, language, CSF and imaging assessments represent reliable biomarkers of disease progression also according to the clinical phenotype
Preliminary Data:
Cross-sectional data suggest that current motor, cognitive, language and imaging assessments may be useful in supporting the diagnosis of PSP compared to PD and HC, but not in characterizing the PSP clinical phenotypes. No robust data on wearable sensors and CSF biomarkers is available.
Longitudinal data on such biomarkers are lacking. As for cognition, preliminary data suggest that the Repeatable Battery for the assessment of neuropsychological status (RBANS) may evaluate cognitive trajectories in PSP with Richardson's syndrome.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Progressive Supranuclear Palsy based on current available clinical criteria
- •ability to walk for at least 5 steps
排除标准
- •Comorbidities interfering with study assessments
- •Significant MRI abnormalities as cerebrovascular diseases, tumors.
结局指标
主要结局
Progressive Supranuclear Palsy rating scale
时间窗: 1-year follow up
Progression of disease as assessed with the standard clinical scale rating (scoring 0-100, higher scores indicate worse scores) Progressive Supranuclear Palsy symptoms and signs
次要结局
- MRI(1-year follow up)
- Cognitive progression(1-year follow up)
- Behavioral progression(1-year follow up)
- Gait speed(1-year follow up)
研究者
Marina Picillo
Doctor
University of Salerno