LY4006896 for Parkinson's (NCT06809400)
Assess safety of Parkinson medication
- Trial ID
- NCT06809400
- Official Title
- A Single- and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY4006896 in Healthy Participants and Participants With Parkinson's Disease
- Goal
- Assess safety of Parkinson medication
- Phase
- PHASE1
- Status
- RECRUITING
- Sponsor
- Eli Lilly and Company
- Study Type
- INTERVENTIONAL
- Enrollment
- 127 participants
- Conditions
- Parkinson Disease
- Interventions
- LY4006896, Placebo
Summary For Families
The goal is to find out whether a new medication is safe, comfortable to take, and how it is absorbed and cleared by the body in both healthy people and people with Parkinson's disease. Participants receive the new medication or a placebo by infusion into a vein, with single dose testing in healthy adults and multiple increasing dose levels in people with Parkinson's, and the study follows people for many months to monitor effects and how the drug behaves, up to about 78 weeks total for those with Parkinson's and up to 53 weeks for healthy volunteers. Healthy adults aged 30 to 85 with a body mass index of 18 to 34 can join the single-dose part, and people with Parkinson's aged 40 to 85 who meet standard United Kingdom clinical criteria, score at least 24 on a brief thinking and memory test, and are either untreated but stable or on a stable dose of Parkinson's medicines for at least 90 days can join the multiple-dose part; people with implanted neurostimulation devices, ongoing continuous-infusion Parkinson's therapies, serious immune or allergy problems, uncontrolled high blood pressure, or significant anemia are not eligible.
Locations
- Collaborative Neuroscience Network - CNS, Los Alamitos, California, United States
- Collaborative Neuroscience Network - CNS, Los Alamitos, California, United States
- K2 Medical Research, LLC, Maitland, Florida, United States
- Aqualane Clinical Research, Naples, Florida, United States
- Charter Research, Orlando, Florida, United States
- Progressive Medical Research, Port Orange, Florida, United States
- K2 Medical Research, LLC, The Villages, Florida, United States
- Charter Research, The Villages, Florida, United States
- QUEST Research Institute, Farmington Hills, Michigan, United States
- PPD Development, LP, Austin, Texas, United States
- Evergreen Health Research, Kirkland, Washington, United States
- Inland Northwest Research, Spokane, Washington, United States
- P-One Clinic, Hachiōji, Japan
- Oita University Hospital, Yufu, Japan
Frequently Asked Questions
- What is this trial testing?
- This trial is studying LY4006896. The goal is to find out whether a new medication is safe, comfortable to take, and how it is absorbed and cleared by the body in both healthy people and people with Parkinson's disease. Participants receive the new medication or a placebo by infusion into a vein, with single dose testing in healthy adults and multiple increasing dose levels in people with Parkinson's, and the study follows people for many months to monitor effects and how the drug behaves, up to about 78 weeks total for those with Parkinson's and up to 53 weeks for healthy volunteers. Healthy adults aged 30 to 85 with a body mass index of 18 to 34 can join the single-dose part, and people with Parkinson's aged 40 to 85 who meet standard United Kingdom clinical criteria, score at least 24 on a brief thinking and memory test, and are either untreated but stable or on a stable dose of Parkinson's medicines for at least 90 days can join the multiple-dose part; people with implanted neurostimulation devices, ongoing continuous-infusion Parkinson's therapies, serious immune or allergy problems, uncontrolled high blood pressure, or significant anemia are not eligible.
- Who can participate?
- Participants must be between 30 Years and 85 Years.
- Where is this trial located?
- This trial is recruiting at 14 locations.
- Does it cost anything to join?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This Phase 1 trial is estimated to last approximately 2 years and 10 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.