A Study of AB-1005 Gene Therapy in Japanese Adults With Moderate Parkinson's Disease (J-REGENERAT… (NCT07566429) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Study of AB-1005 Gene Therapy in Japanese Adults With Moderate Parkinson's Disease (J-REGENERATE-PD)
Japan8 participantsStarted 2027-01-25
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 range
45 Years – 75 Years
Sex
ALL
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing AB-1005 gene therapy, which involves directly altering genes to treat Parkinson's — can you explain what that procedure actually involves and what risks come with it that are different from my current medications?
2The trial is still in Phase 2 and hasn't started recruiting yet, which means there's limited long-term safety data available — given where I am in my disease right now, does it make more sense to consider this kind of early-phase study or stick with established treatments first?
3One of the main things this study is measuring is how much 'Good ON time' I have over 18 months — can you help me understand what that means for my specific situation and whether my current ON/OFF patterns would even make this a meaningful measure for me?
4Since this trial is specifically for Japanese adults and hasn't started recruiting yet, is this something that could realistically be an option for me in the near future, or is the timeline too uncertain to factor into my treatment planning right now?
5The study tracks adverse events all the way out to 18 months after the gene therapy intervention — what kinds of side effects or complications are doctors watching for most closely with this type of gene therapy in Parkinson's patients?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of adverse events up to Month 18 after study intervention
Timeframe: Up to 18 months
2
Change from Baseline to Month 18 in normalized Good ON time measured with PD Motor Diary