ClinicaliQ Trial Snapshot
- A Clinical Trial of LY3962681 in Healthy Volunteers and in Patients With Parkinson’s Disease — Recruiting • Phase I • Neurology • NCT06565195.
- Drug being tested: LY3962681, a novel investigational compound undergoing evaluation for safety, tolerability, and pharmacokinetic/pharmacodynamic properties in both healthy volunteers and Parkinson's disease patients through single and multiple ascending dose study designs.
- Patient eligibility overview: The trial includes two populations—healthy volunteer controls and patients with confirmed Parkinson's disease diagnosis—allowing comparison of drug response between disease-free and affected populations across different dose escalation phases.
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What This Trial Is Studying
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics/pharmacodynamics (PK/PD) of LY3962681 in healthy volunteers and patients with Parkinson's disease. The study consists of two parts, the Single Ascending Dose (SAD) study and the Multiple Ascending Dose (MAD) study. During the SAD portion of the study, healthy volunteers will receive a single dose of LY3962681 or placebo (artificial cerebrospinal fluid [aCSF]) administered intrathecally (into the spinal fluid). During the MAD portion of the study, patients with Parkinson's disease will receive two doses of either LY3962681 or…
Eligibility Snapshot
- : * 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. MAD study only * 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. * 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 20 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…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.