RecruitingPhase 2

A Study of AAV2-GDNF in Adults With Moderate Parkinson's Disease (REGENERATE-PD)

United States, Germany, Poland127 participantsStarted 2024-06-11

Plain-language summary

The objective of this randomized, surgically controlled, double-blinded, Phase 2 study is to evaluate the safety and efficacy of AAV2-GDNF delivered to the putamen in subjects with moderate Parkinson's Disease.

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

. Male and female adults 45-75 years of age inclusive, at the time of signing of informed consent Type of Subject and Disease Characteristics
. Diagnosed with Parkinson's disease in the past 4-10 years (inclusive) as defined by the following:
. Presence of bradykinesia PLUS any of the following:
. Presence of motor fluctuations as measured by the PD Motor Diary
. Stable anti-parkinsonian medication regimen for \>/= 4 weeks prior to screening
. Must demonstrate 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.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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

Change from baseline to Month 18 on PD Motor Diary

Timeframe: 18 months

Trial details

NCT IDNCT06285643

SponsorAskBio Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-08-31

Contact for this trial

Nisha Chhabria, MD

919-388-1040 askfirst@askbio.com

View on ClinicalTrials.gov More Parkinson Disease trials