A Study of AB-1005 Gene Therapy in Japanese Adults With Moderate Parkinson's Disease (J-REGENERATE-PD)

Sponsor
Bayer
Study ID
NCT07566429
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
45 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • AB-1005 — DRUG
    Bilateral image-guided infusion of AAV2-GDNF into putamen, single dose

Study Details

The objective of this Phase 2, open-label, single group, one-time, fixed-dose study is to assess the safety and efficacy of bilateral intraputaminal infusion of AB-1005 (AAV2-GDNF gene therapy) in Japanese patients with moderate Parkinson's Disease (PD).

Key Dates

First listed
May 5, 2026
Start date
Jul 27, 2026
Status verified
May 2026
Primary completion
Dec 15, 2028
Completion
Jun 15, 2032

Study Design

Enrollment
8 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: AB-1005 infusion

Primary Outcome Measure

Incidence of adverse events up to Month 18 after study intervention [ Time Frame: Up to 18 months ]

Central Contacts

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