Study Rationale: People with Parkinson’s disease (PD) frequently develop a loss of motivation and initiative. Such apathy can be burdensome for patients and their families and caregivers and is associated with a constellation of symptoms, such as social disengagement, difficulty thinking and loss of emotion, leading to an impaired ability to initiate and maintain activities that worsens with time. We have identified a chemical compound called IRL757 that could potentially be used as an adjunct treatment to improve the cognitive abilities that underlie apathy and thereby improve quality of life for people and families affected by PD.
Hypothesis: In preclinical models, IRL757 displays potential to improve cognitive functions in the forebrain, neuronal systems that are dysregulated in people with apathy. In this study, the aim is to confirm that IRL757 administration is safe in humans and to assess how the study drug is processed by the body.
Study Design: The safety of IRL757 will be assessed in healthy volunteers after single and repeated administrations (14-day treatment) of the compound by monitoring the well-being of all study participants through physical examinations and reported adverse events. Vital signs, blood samples and electrocardiograms will also be analyzed.
Impact on Diagnosis/Treatment of Parkinson’s Disease: IRL757 is intended to be used as an additional treatment for people affected by PD that are suffering from significant apathy. It is not meant to replace existing treatments for PD but would rather be an additional tool in the toolbox for treating the range of symptoms in PD.
Next Steps for Development: If this phase 1 study is successful, the next step would be to conduct another study in healthy volunteers to evaluate how the compound interacts with receptors in the brain. This information would be used to determine which doses will be evaluated in further clinical studies.
Trial Phase: Phase 1