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EVALUATING COGNITION IN PARKINSON’S DISEASE CLINICAL TRIALS: KEY CONSIDERATIONS FOR STUDY DESIGN AND CONDUCT

March 19, 2019 | (11:00 AM)
USA (United States of America)
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 labeling 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: