Reduce toxic brain protein clumps
- Trial ID
- NCT06565195
- Official Title
- A Randomized, Double-blind (Sponsor-unblinded), Placebo-controlled, Single-ascending-dose Study in Healthy Volunteers and a Double-blind (Sponsor-unblinded), Placebo-controlled, Multiple-ascending-dose Study in Patients With Parkinson's Disease to Evaluate the Safety, Tolerability, and PK/PD of LY3962681
- Goal
- Reduce toxic brain protein clumps
- Phase
- PHASE1
- Status
- RECRUITING
- Sponsor
- Prevail Therapeutics
- Study Type
- INTERVENTIONAL
- Enrollment
- 124 participants
- Conditions
- Parkinson's Disease
- Interventions
- LY3962681, Placebo (aCSF)
Summary For Families
The goal is to test whether LY3962681 can be safely given into the cerebrospinal fluid and alter alpha-synuclein-related biology that is thought to drive Parkinson's progression, by studying safety, tolerability, and how the drug moves and acts in the body. LY3962681 is an experimental agent delivered by lumbar puncture into the CSF, intended to engage and reduce toxic alpha-synuclein seeds in the brain, and it is being compared to placebo while allowing participants to stay on stable Parkinson medications, including levodopa. The trial enrolls healthy adults for single ascending doses and people with early-stage Parkinson's aged 30 to 80, with Hoehn and Yahr stage 1 to 2.5 OFF, a positive CSF alpha-synuclein assay and supportive tests like DaT-SPECT or smell loss, plus a MoCA of 24 or higher. People with other major neurological diseases, unstable medical conditions, or bleeding risks that would make lumbar puncture unsafe are excluded.
Locations
- Austin Clinic PPD, Austin, Texas, United States
- Ehime University Hospital, Tōon, Ehime, Japan
- Oita University Hospital, Yufu, Oita Prefecture, Japan
- P-One Clinic, Keikokai Medical Corporation, Hachiōji, Tokyo, Japan
Frequently Asked Questions
- What is this trial testing?
- This trial is studying LY3962681. The goal is to test whether LY3962681 can be safely given into the cerebrospinal fluid and alter alpha-synuclein-related biology that is thought to drive Parkinson's progression, by studying safety, tolerability, and how the drug moves and acts in the body. LY3962681 is an experimental agent delivered by lumbar puncture into the CSF, intended to engage and reduce toxic alpha-synuclein seeds in the brain, and it is being compared to placebo while allowing participants to stay on stable Parkinson medications, including levodopa. The trial enrolls healthy adults for single ascending doses and people with early-stage Parkinson's aged 30 to 80, with Hoehn and Yahr stage 1 to 2.5 OFF, a positive CSF alpha-synuclein assay and supportive tests like DaT-SPECT or smell loss, plus a MoCA of 24 or higher. People with other major neurological diseases, unstable medical conditions, or bleeding risks that would make lumbar puncture unsafe are excluded.
- Who can participate?
- Participants must be between 30 Years and 80 Years.
- Where is this trial located?
- This trial is recruiting at 4 locations.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This Phase 1 trial is estimated to last approximately 4 years and 8 months.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- 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.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- 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.