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
- 108 participants
- Conditions
- Parkinson's Disease
- Interventions
- LY3962681, Placebo (aCSF)
Plain-Language Summary
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.