Not Yet RecruitingPhase 2

A Study of AB-1005 Gene Therapy in Japanese Adults With Moderate Parkinson's Disease

Japan8 participantsStarted 2026-07-27

Plain-language summary

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).

Who can participate

Age range45 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Presence of bradykinesia PLUS any of the following: rigidity, rest tremor, postural instability
✓. Presence of motor fluctuations as measured by the PD Motor Diary
✓. Stable anti-parkinsonian medication regimen for 4 weeks or more, prior to screening
✓. Responsiveness to levodopa therapy

What they're measuring

Incidence of adverse events up to Month 18 after study intervention

Timeframe: Up to 18 months

Change from Baseline to Month 18 in normalized Good ON time measured with PD Motor Diary

Timeframe: Up to 18 months

Trial details

NCT IDNCT07566429

SponsorBayer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-12-15

Contact for this trial

Bayer Clinical Trials Contact

18888422937 clinical-trials-contact@bayer.com

View on ClinicalTrials.gov More Parkinson Disease trials