Landmark 160 · Trial in people
REGENERATE-PD AB-1005
It will tell us whether this gene therapy gives more good on-time than sham surgery at 18 months. GDNF infusions improved scans but not patients.
In short
A sham-surgery-controlled Phase 2 of a one-time GDNF gene therapy in moderate Parkinson's; primary completion estimated August 2028.
- What it is
- Trial in people
- Outcome
- Result due Aug 2028
- When
- 2024–2028
- Size
- 127 people · Phase 2
- Approach
- Replace or repair what's lost
- Research lane
- Growth factors
- Trial registry
- NCT06285643
- Last checked
- 18 Oct 2026
The research record
This is the project's file for this landmark, as written and checked. Sources are listed at the end; anything not yet confirmed is marked "Not yet verified".
Who
AskBio (Bayer). Registry NCT06285643; sites in the US, Germany, Poland and the UK.
What is being tested
AB-1005, a virus carrying the GDNF gene, infused into both putamens in one operation, against sham surgery (partial burr holes with no dura penetration). Ages 45–75. Started 11 Jun 2024; first randomisations announced Jan 2025; registry shows active, not recruiting. Builds on landmark 39. A Japanese study, J-REGENERATE-PD (NCT07566429), is separate.
What would count as success
Primary: change from baseline at month 18 in diary good ON time (Hauser diary). A clear gain over sham, ideally with scan evidence of more dopamine terminals, would revive growth factors after the infusion trials failed.
Surgery uses real-time MRI-guided convection-enhanced infusion (landmark 253).
Sources
- ClinicalTrials.gov NCT06285643
- Bayer, first participants randomised
- Not yet verified: enrolment (brief says about 87; the registry now shows 127 estimated); whether the registry's August 2028 date matches the sponsor's.
How it connects
Built on
- builds on GDNF: the growth-factor idea, from infusions to gene therapy · 2003
- uses MRI-guided convection-enhanced delivery · 2005
Led to
None recorded.