Evaluating Cognition in Parkinson’s Disease Clinical Trials: Key Considerations for Study Design and Conduct

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 will 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.

Speakers

Eric Siemers, Distinguished Medical Adviser, Cogstate

Dr. Eric Siemers’ experience in clinical trials of neurodegenerative disease spans over 25 years, with a research focus on biomarkers in investigational drug research, the development of trial designs that fully characterize the effects of investigational drugs on chronic diseases, and more specifically, the development of strategies for treating individuals before the onset of symptoms of neurodegenerative diseases. He most recently served as Distinguished Medical Fellow for Eli Lilly and Company’s Alzheimer’s Disease (AD) Global Development Team, where he was responsible for the design and implementation of five large phase III clinical studies of AD sponsored by Lilly, in addition to playing a major collaborative role in two public-private partnership studies. Prior to his appointments at Lilly, Dr. Siemers founded and headed the Indiana University Movement Disorder Clinic. His researchincluded investigations of Parkinson’s disease and Huntington’s disease, and he established one of the first centers for surgical PD treatments in the US.

Dr. Siemers earned his MD with highest distinction from the Indiana University School of Medicine, where he completed an internship in the Department of Internal Medicine and residency in the Department of Neurology.

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Chris Edgar, Senior Vice President, Clinical Science, Cogstate

Dr. Chris Edgar is an experienced leader in cognitive assessment and clinical endpoint strategy who provides expert guidance to Cogstate’s pharmaceutical customers through all stages of trial conduct, from study design and test selection to final analysis. He is also a key advisor to Cogstate’s commercial and product teams for the development of new technologies and approaches in line with industry needs. Dr. Edgar joins Cogstate from Roche where he oversaw clinical endpoint strategy for multiple neuroscience indications in the Patient-Centered Outcomes Research group. He has also held other strategic positions including clinical scientist at Roche on schizophrenia and Alzheimer’s disease drug development programs, senior clinical lead for rater training and data quality at Bracket and scientific director at Cognitive Drug Research Ltd., a computerized cognitive assessment company.

He holds a PhD in Psychopharmacology from Northumbria University and has nearly two decades of pharmaceutical industry experience. 

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Lisle Kingery, Clinical Science Director, Cogstate

Lisle Kingery, PhD is a licensed clinical psychologist (neuropsychologist) with 20 years’ clinical and research experience in clinical psychology and neuropsychology. He has directed rater training programs in over 20 Alzheimer’s disease clinical trials, three Parkinson’s disease trials, and several other trials for other CNS indications, as well as evaluated and trained raters globally at dozens of clinical trial investigator meetings.

Dr. Kingery completed a PhD in clinical psychology at the University of Maine, an internship in clinical neuropsychology at the Ann Arbor VA Healthcare System/the University of Michigan and a postdoctoral fellowship in clinical neuropsychology at Johns Hopkins University School of Medicine in the Division of Medical Psychology, Department of Psychiatric and Behavioral Sciences. After teaching neuropsychological assessment and biopsychology for one year at Loyola University of Maryland, Baltimore, Dr. Kingery joined the Clinical Training and Assessment division of i3 research in 2006, where he contributed to both the operational and scientific components of clinical assessment services in global clinical trials.

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Paul Maruff, Chief Science Officer, Cogstate

Professor Paul Maruff is a founder of Cogstate and a neuropsychologist with expertise in the measurement of subtle behavioral and cognitive dysfunction in neuropsychiatric/neurological disease and in brain injury.  His research integrates conventional and computerized neuropsychological testing with cognitive neuroscientific methods, neuroimaging, genetics and clinical assessment to guide decision-making in clinical medicine in drug development. Paul has worked extensively to develop methods for identification of the nature and magnitude of cognitive impairment, and to assess the efficacy of licensed and experimental drugs and procedures, in Alzheimer’s disease, mild cognitive impairment and the HIV dementia complex. 

He has extended these methods to the identification of cognitive dysfunction and the effects of treatment in psychiatric diseases such as schizophrenia, attention deficit disorder and obsessive-compulsive disorder, major depressive disorder and substance abuse in adults and children. In addition to being responsible for the scientific progress at Cogstate, Paul is also appointed Professor at the Florey Institute for Neuroscience and Mental Health where is an active member of the Alzheimer’s disease research group.

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