This grant builds upon the research from a prior grant: Assessment of IRL757 for the Treatment of Apathy in Parkinson's Disease
Study Rationale: People with PD frequently develop a loss of motivation and initiative. This phenomenon is called apathy and can be a very burdensome symptom of PD, affecting not only the patient but also causing considerable distress for the family and caregivers. Apathy, which is different from depression, is associated with a constellation of symptoms, such as social disengagement, difficulty in thinking, and loss of emotion, that result in impaired ability to initiate and maintain activities. Apathy cannot effectively be treated, and usually gets worse with time.
We have identified a type of chemical compound called IRL757 that could potentially be used as an adjunct treatment to improve certain parts of the brain’s ability to function. This would potentially improve the thinking abilities that underlie apathy and thereby improve quality of life for people and families affected by PD.
Hypothesis: In pre-clinical models, IRL757 displays potential to improve functions in the forebrain, neuronal systems that are dysregulated in people with impaired cognitive function and 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 by 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 and that are suffering from significant apathy. It is not meant to replace actual existing treatments for PD but would rather be an additional tool in the toolbox for the treatment of 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 is binding to certain receptors in the human brain. This would help to assess which doses will be evaluated in further clinical studies.
Trial Phase: Phase 1