Study Rationale: People with Lewy body disorders, including Parkinson’s disease (PD) and dementia with Lewy bodies (DLB), often experience cognitive impairment that can impact function, independence and quality of life. At present, there are few effective therapeutics for cognitive symptoms, and no treatments that slow or halt cognitive decline in PD or DLB. Most clinical trials have used cognitive tests that are not necessarily specific for PD or DLB. Whether these measures are optimally suited for use in symptomatic or disease-modifying trials for PD and DLB cognition remains unclear.
Hypothesis: By identifying which cognitive tests are best suited for clinical trials in PD and DLB, we hypothesize that we can develop evidence-based recommendations that can be used along the FDA regulatory path of clinical trials to advance cognitive treatments for PD and DLB.
Study Design: We will conduct a review of cognitive measures used in the published literature and in clinical trials of PD and DLB to examine how these tests are used to assess cognitive changes, the evidence that supports their use and the gaps that still need to be filled to use them effectively. We will then evaluate these cognitive measures and their use to develop a set of data-driven recommendations through group consensus.
Impact on Diagnosis/Treatment of Parkinson’s disease: This project could impact how researchers design and conduct clinical trials for cognitive impairment in PD and DLB, including symptomatic and disease-modifying therapies. Our results will help guide clinicians, researchers and regulatory agencies in industry and the FDA in their approaches to measure cognitive changes and effects of interventions in Lewy body disorders.
Next Steps for Development: Next steps towards the clinical application of study results will include implementing test recommendations from this project and developping additional cognitive test measures for Lewy body disorders.