PD-MIND · Parkinson Disease with Mild cognition Impairment treated with Nicotinic agonist Drug

Parkinson Disease (PD) is the second most common neurodegenerative disease after Alzheimer’s disease. There is an unmet clinical need to treat Parkinson disease with mild cognitive impairment (PD-MCI). There is ample evidence from epidemiological studies as well as (pre)clinical research that Nicotinic receptors are involved in PD and cognition. Recently a clinical trial suggested that selective α7 nicotinic receptor agonist improved cognition in PD patients, as a secondary outcome measure. Hence, the main goal of PD-MIND is to show the potential of the Astrazeneca nicotinic α7 agonist AZD0328 in a randomized, placebo-controlled, international multicentre, cross-over study on cognition in people diagnosed with PD-MCI. We will assess the Attention Intensity Index composite score from the CogTrackTM system as primary outcome measure and other clinical aspects (cognition, motor symptoms) as secondary outcomes. In addition, blood, CSF and imaging biomarkers will be assessed as potential predictors of response, and as marker of target involvement. Patients (Public and Patient Involvement) and other stakeholders will be engaged from the start to allow integration of end-user perspectives in the design and execution of the project. PD-MIND will put considerably effort to disseminate and exploit clinical outcome data and biomarker results, and to sustain the partnership for subsequent phase 3 clinical studies. PD-MIND consortium consist of world-leading PD-MCI experts in the area of clinical trials, clinical coordination, project management, data management and analysis, and biomarkers. As such the consortium is well positioned to execute the proposed work and complement the EFPIA members.