A Phase 2 interventional study of AB-1005 in Parkinson Disease, sponsored by Bayer. Not yet recruiting at 6 sites in Japan. Open to participants aged 45 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by Bayer · Phase 2, Interventional, and Treatment
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).
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's planned enrollment of 8 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
Diagnosed with Parkinson's disease in the past 4-10 years (inclusive) and currently meeting all the following criteria:
Exclusion Criteria:
Drug: AB-1005
Bilateral image-guided infusion of AAV2-GDNF into putamen, single dose
Incidence of adverse events up to Month 18 after study intervention
Number and proportion of participants with at least one adverse event
Time frame: Up to 18 months
Change from Baseline to Month 18 in normalized Good ON time measured with PD Motor Diary
Time frame: Up to 18 months
Plan to share: No — Currently, there is no established plan for the sharing of Individual Patient Data (IPD) from this study. The availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA 'Principles for responsible clinical trial data sharing.' This pertains to the scope, timepoint, and process of data access. As such, Bayer commits to considering requests from qualified researchers for patient- / study-level clinical trial data, and documents from clinical trials involving medicines and indications approved in the US and EU. However, this commitment does not reflect an active IPD sharing plan. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Researchers can use www.vivli.org to request access to IPD and documents from clinical studies to conduct research. Information on Bayer's criteria for listing studies is provided in the member section of the portal.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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