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Predicting disease progression in progressive supranuclear palsy in multicenter clinical trials
Jee Bang1, Iryna V Lobach2, Anthony E Lang3
1Memory and Aging Center, Department of Neurology, University of California San Francisco, 675 Nelson Rising Lane, Suite 190, San Francisco, CA, USA 94158.
Parkinsonism & Related Disorders
|May 14, 2016
Summary
This study identified key clinical and MRI measures for tracking progressive supranuclear palsy (PSP) progression in trials. These validated tools accurately capture disease decline and predict outcomes in multicenter studies.
Area of Science:
- Neurology
- Clinical Trials
- Neuroimaging
Background:
- Progressive Supranuclear Palsy (PSP) disease progression tracking requires validated measures for multicenter clinical trials.
- Existing clinical and MRI assessments need robust evaluation for efficacy in capturing disease decline.
Purpose of the Study:
- To identify optimal clinical and MRI measurements for tracking disease progression in Progressive Supranuclear Palsy (PSP).
- To evaluate the sensitivity of various measures in predicting clinical decline and patient dropout in multicenter PSP trials.
Main Methods:
- Utilized longitudinal data from a phase 2/3 clinical trial of davunetide for PSP (n=303).
- Assessed clinical rating scales, neuropsychological tests, and volumetric MRI data.
- Identified measurements with the largest effect size, strongest correlation with clinical change, and best predictive ability for decline or dropout over one year.
Main Results:
- Repeatable Battery for Assessing Neuropsychological Status (RBANS) at baseline correlated with attrition.
- PSP Rating Scale (PSPRS) and Clinical Global Impression (CGI) showed the largest effect sizes for change.
- Annual changes in CGI, RBANS, color trails, and MRI midbrain/ventricular volumes strongly correlated with PSPRS annual change.
Conclusions:
- Baseline cognitive status and mood significantly influence PSP disease progression rates.
- Multiple clinical, neuropsychological, and volumetric MRI measures are sensitive to one-year changes in PSP.
- These validated measures are suitable for use in multicenter clinical trials for Progressive Supranuclear Palsy.
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