A Clinical Trial of LY3962681 in Healthy Volunteers and in Patients With Parkinson's Disease

Launched by PREVAIL THERAPEUTICS · Aug 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new drug called LY3962681 to see how safe it is and how it works in healthy volunteers and patients with Parkinson's disease. The trial has two parts: in the first part, healthy volunteers will receive a single dose of the drug or a placebo (which is a substance with no active drug) directly into their spinal fluid. In the second part, patients with Parkinson's disease will receive two doses of either LY3962681 or a placebo into their spinal fluid, with some time in between the doses.

To participate in this trial, healthy volunteers need to be in good health, while patients must have a confirmed diagnosis of Parkinson's disease and meet certain criteria related to their condition. Participants can expect to be monitored closely during the treatment period, which lasts from one to two days, and they will have follow-up visits for up to 52 weeks afterward. It's important to know that this trial is currently recruiting participants, and there are specific health requirements that must be met to ensure everyone's safety.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Participant is overtly healthy as determined by medical evaluation. Rescreening is allowed in this study.
• • A Montreal Cognitive Assessment score greater than or equal to 24.
• • Stable use of background medications at least 8 weeks prior to IP administration, including but not limited to those used for treatment of Parkinson's disease (including deep brain stimulation), and the investigator must expect that participant can tolerate a minimum of 6 months without dose adjustment.
• • MAD study only
• • Participant has a diagnosis of Parkinson's disease per UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria.
• • Modified Hoehn and Yahr Stage 1 to 2.5 in the practically defined OFF state.
• • A positive result on CSF alpha-synuclein Seed Amplification Assay. (A prior positive result \[within 1 year of screening\] accepted with sponsor approval if patient did not participate in another Parkinson's disease clinical trial during this period.) (US and Japan only)
• • UPSIT score of 10 percentile or less, corrected for age and sex (EU and UK only).
• • An abnormal DaT-SPECT consistent with parkinsonism. (History of an abnormal DaTSPECT with the report confirmed by study investigator will be accepted.)
• • For participants not taking Parkinson's disease medications, not expected to initiate treatment within 6 months.
• • Have a body weight within 40 kg (88 pounds) to 110 kg (242 pounds), inclusive, and body mass index within the range of 17 to 34 kg/m\^2, inclusive.
• Exclusion Criteria:
• • MAD study only: Significant neurological disease affecting the central nervous system other than Parkinson's disease that may be a cause for the participant's clinical symptoms or may confound study objectives.
• • Current concomitant disease or serious or unstable illnesses, including central nervous system (SAD study only), cardiovascular, hepatic, renal, gastroenterology, respiratory, endocrinologic, neurologic (MAD study only: other than Parkinson's disease), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with the conduct of the study or that would, in the opinion of the investigator, pose an unacceptable safety risk to the participant.
• • Participant is generally frail or has any medical disorders that, in the opinion of the investigator, could interfere with study-related procedures (including safe performance of IT injection or LP), such as prohibitive spinal diseases, bleeding diathesis, clinically significant coagulopathy, thrombocytopenia, or increased intracranial pressure.
• • Have a 12-lead ECG abnormality at screening that, in the opinion of the investigator, increases the risks associated with participating in the study or may confound ECG data analysis.
• • MAD study only: Treatment with continuous intestinal delivery Parkinson's disease medication (for example, Duodopa).
• • Other protocol-defined inclusion/exclusion criteria may apply.