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Towards regulatory acceptance of digital outcome measures for Parkinson’s Disease

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If you have a question about this talk, please contact Cecilia Mascolo.


Parkinson’s is the second most common age-related neurodegenerative disease and no treatments exist that can affect its underlying cause. Currently available medications can modify symptoms but do not prevent or delay disease progression: Levodopa, discovered in the 1960s, continues to be the most efficacious drug. While the number of candidate compounds for new medicines continues to expand, over the past three decades the number of new licensed compounds has been sparse. A key reason for this lack of progress is the paucity of objective, sensitive, and clinically interpretable measures that can capture meaningful aspects of the disease. This situation is compounded by the considerable heterogeneity in clinical manifestations of Parkinson’s across patients and the highly fluctuating nature of its symptoms. Digital health technologies, typically incorporating smartphone apps and wearable sensors, offer the potential to enable the objective, decentralised, and frequent measurement of Parkinson’s signs and symptoms in natural living environments. This talk reports on recent developments and key remaining challenges towards providing conclusive evidence aligned to regulator expectations so that outcomes measures created using such digital technologies can be adopted in drug development studies.

This talk is part of the Mobile and Wearable Health Seminar Series series.

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