๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-06-25

A Study of AAV2-GDNF in Adults With Moderate Parkinson's Disease (REGENERATE-PD) (NCT06285643)

A Phase 2, Randomized, Double-blind, Sham Surgery-controlled Study of the Efficacy and Safety of Intraputaminal AAV2-GDNF in the Treatment of Adults With Moderate Stage Parkinson's Disease

๐ŸŸข Recruiting Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: AskBio Inc

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

The objective of this randomized, surgically controlled, double-blinded, Phase 2 study is to evaluate the safety and efficacy of AAV2-GDNF delivered to the putamen in subjects with moderate Parkinson's Disease.

Who can join: Review the eligibility criteria below.

Location: Mayo Clinic โ€” Phoenix, Arizona

Age range: 45 Years to 75 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (46 Sites)

Showing the first 25 of 46 sites.

  • Mayo Clinic โ€” Phoenix, Arizona
  • UCI Alpha Clinic (Neurology) โ€” Irvine, California
  • Loma Linda University (Neurology) โ€” Loma Linda, California
  • Loma Linda University (Surgical) โ€” Loma Linda, California
  • University of California San Francisco (Neurology) โ€” San Francisco, California
  • University of San Francisco (Surgical) โ€” San Francisco, California
  • CenExel Rocky Mountain Clinical Research (Neurology) โ€” Englewood, Colorado
  • Georgetown University (Neurology) โ€” Washington D.C., District of Columbia
  • Parkinson's Disease and Movement Disorders Center of Boca Raton (Neurology) โ€” Boca Raton, Florida
  • University of Florida โ€” Gainesville, Florida
  • University of Miami โ€” Miami, Florida
  • Orlando Health Neuroscience Institute โ€” Orlando, Florida
  • Parkinson's Disease Treatment Center of Southwest Florida (Neurology) โ€” Port Charlotte, Florida
  • Emory University (Surgical) โ€” Atlanta, Georgia
  • Rush University Medical Center (Neurology) โ€” Chicago, Illinois
  • University of Kansas Medical Center (Neurology) โ€” Kansas City, Kansas
  • Massachusetts General Hospital (Neurology) โ€” Boston, Massachusetts
  • Massachusetts General Hospital (Surgical) โ€” Boston, Massachusetts
  • Michigan State University (Neurology) โ€” East Lansing, Michigan
  • Quest Research Institute (Neurology) โ€” Farmington Hills, Michigan
  • Cleveland Clinic Lou Ruvo (Neurology) โ€” Las Vegas, Nevada
  • Columbia University โ€” New York, New York
  • University of North Carolina (Neurology) โ€” Chapel Hill, North Carolina
  • Duke Neurosurgery (Surgical) โ€” Durham, North Carolina
  • Duke University (Neurology) โ€” Durham, North Carolina

๐Ÿ“ž Contact the Study Coordinator

Phone: (919) 388-1040

Email: askfirst@askbio.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ 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 ยง 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.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—