Overview
The past two decades have seen multiple industry trials explore the impact of drug treatments (primarily dopaminergic therapies and cholinesterase inhibitors) on cognition in Parkinson’s disease (PD) and PD dementia (PDD). This activity resulted in the approval of rivastigmine for PDD in 2007 but has not resulted in any further approvals or in labelling for cognition endpoints. And with respect to cognition, the focus for industry trials has remained on secondary or exploratory outcomes in idiopathic PD, or primary outcomes in PDD. In recent years, three important efforts have begun to alter planned clinical development programs in important ways:
- Diagnostic criteria for Mild Cognitive Impairment in PD (PD-MCI), published in 2012
- The FDA Parkinson’s Disease “Voice of the Patient” meeting, held in 2015
- Development of potentially disease-modifying therapies (DMTs), especially those targeted at α-synuclein (e.g. Prasinezumab (RO7046015/PRX002)) Phase II, ongoing
Given these efforts, it is clear that the symptoms of cognitive impairment in people with PD are considered significant. In this webinar, our featured speakers address important trends in the identification of patient populations suitable for trials of cognition-enhancing or disease-modifying therapies, related issues of trial design and key considerations in the selection and successful application of clinical outcomes assessments, with a focus on cognitive outcomes.
Featured Speakers
- Eric Siemers, Distinguished Medical Adviser, Cogstate
- Chris Edgar, Senior Vice President, Clinical Science, Cogstate
- Lisle Kingery, Clinical Science Director, Cogstate
- Paul Maruff, Chief Science Officer, Cogstate
