Phase 1/2a Clinical Trial of PR001 (LY3884961) in Patients With Parkinson's Disease With at Least One GBA1 Mutation (PROPEL) (NCT04127578)
A Phase 1/2a Open-Label Ascending Dose Study to Evaluate the Safety and Effects of LY3884961 in Patients With Parkinson's Disease With at Least One GBA1 Mutation (PROPEL)
🩺 Plain-English Summary (8th-Grade Level)
Study J3Z-MC-OJAA is a Phase 1/2a, multicenter, open-label, ascending dose, first in-human study that will evaluate the safety of intracisternal LY3884961 administration in patients with moderate to severe Parkinson's disease with at least 1 pathogenic GBA1 mutation. Two dose level cohorts of LY3884961 are planned (Dose Level 1 and Dose Level 2). The duration of the study is 5 years. During the first year, patients will be evaluated for the effect of LY3884961 on safety, tolerability, immunogenicity, biomarkers, and clinical efficacy measures. Patients will continue to be followed for an additional 4 years to continue to monitor safety as well as selected biomarker and efficacy measures.
Who can join: Review the eligibility criteria below.
Location: Mayo Clinic, 13400 E. Shea Boulevard — Scottsdale, Arizona
Age range: 35 Years to 80 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (15 Sites)
- Mayo Clinic, 13400 E. Shea Boulevard — Scottsdale, Arizona
- Esperanza Clinical, 25220 Hancock Avenue — Murrieta, California
- Rocky Mountain Clinical Research - CenExel - PPDS, 701 East Hampden Avenue Suite 510 — Englewood, Colorado
- K2 Medical Research, 101 Southhall Lane, Suite 150 — Maitland, Florida
- PPD, 100 West Gore Street, Suite 202 — Orlando, Florida
- Northwestern University Feinberg School of Medicine, Dept. of Neurology, Parkinson's Disease & Movement Disorders Center, 710 N. Lake Shore Drive, 11th Floor — Chicago, Illinois
- Mayo Clinic, 200 First Street SW — Rochester, Minnesota
- Mount Sinai Beth Israel, 10 Union Square East, Suite 5H — New York, New York
- Joan and Sanford I. Weill Department of Medicine, 525 E 68th Street — New York, New York
- Hospital of the University of Pennsylvania, 330 S. 9th Street — Philadelphia, Pennsylvania
- Vanderbilt University Medical Center, 1500 21st Avenue South Suite 2600 — Nashville, Tennessee
- Shaare Zedek Medical Center, 12 Shmuel Biet Street — Jerusalem,
- Hadassah Medical Center, Hadassah Ein Kerem, Dept. of Neurology, P.O. Box 12000 — Jerusalem,
- Sheba Medical Center, Tel Hashomer — Ramat Gan,
- Tel Aviv Sourasky Medical Center, 6 Weizmann St. — Tel Aviv,
📞 Contact the Study Coordinator
Phone: (800) 664-4580
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.