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AAV2-GDNF for Moderate Parkinson's Disease (REGENERATE-PD)

This study is looking at a gene therapy called AAV2-GDNF for adults with moderate Parkinson's disease. Researchers want to see if this treatment is safe and if it helps improve movement problems. You might be able to join if you are 45-75 years old and have been diagnosed with Parkinson's disease in the last 4-10 years, showing symptoms like slow movement (bradykinesia) along with stiffness, tremor, or balance issues. The main goal is to see how your Parkinson's symptoms change over 18 months, as measured by a daily diary. The current status of the study is unclear, and it plans to enroll 127 people.

Study design
This is a Phase 2, randomized, surgically controlled, double-blinded study. It aims to enroll 127 participants.
What's involved
Participants will receive a single dose of AAV2-GDNF gene therapy or a control surgery. The primary endpoint is measured at 18 months.
Compensation
Not stated in the trial record.
Follow-up
The main outcome of the study is measured at 18 months after the treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06285643

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

Recruiting
PHASE2Ages 45–75InterventionalTreatment
AskBio Inc
~127 participants
Updated 2026-06-29 on ClinicalTrials.gov
What's tested:AAV2-GDNF gene therapycontrol surgery

At a glance

Recruiting sites
30 of 46 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from baseline to Month 18 on PD Motor Diary
Measured over 18 months

Conditions

Parkinson Disease

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Parkinson Disease

NCT06285643

Where you'd take part

This study runs at 46 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • CenExel Rocky Mountain Clinical Research (Neurology)

    Englewood, Coloradostudy coordinator listed

    Recruiting

  • Cleveland Clinic Lou Ruvo (Neurology)

    Las Vegas, Nevadastudy coordinator listed

    Recruiting

  • Columbia University

    New York, New Yorkstudy coordinator listed

    Recruiting

  • Copernicus Podmiot Leczniczy, Szpital św. Wojciecha (Neurology)

    Gdansk, Polandstudy coordinator listed

    Recruiting

  • Duke University (Neurology)

    Durham, North Carolinastudy coordinator listed

    Recruiting

  • EvergreenHealth Research Department (Neurology)

    Kirkland, Washingtonstudy coordinator listed

    Recruiting

  • Georgetown University (Neurology)

    Washington D.C., District of Columbiastudy coordinator listed

    Recruiting

  • Houston Methodist (Neurology)

    Houston, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Nisha Chhabria, MD
[email protected]
919-388-1040
Email the study team

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Eligibility criteria

Inclusion

Rigidity
Rest tremor
Postural instability 2. Presence of motor fluctuations as measured by the PD Motor Diary 3. Stable anti-parkinsonian medication regimen for \>/= 4 weeks prior to screening 4. Must demonstrate responsiveness to levodopa therapy

Exclusion

Known history or current evidence of medical, genetic, or neurological conditions that may provide an alternative to idiopathic PD diagnosis
Presence or history of significant vascular and/or cardiovascular disease
Presence of significant cognitive impairment, poorly controlled depression/anxiety
Presence or history of psychosis or impulse control disorder
History of malignancy other than treated cutaneous squamous or basal cell carcinomas
Presence of clinically relevant conditions that could compromise surgical suitability and/or subject safety
Contraindication to magnetic resonance imaging and/or use gadolinium-based contrast agents
Prior history of brain surgery including, but no limited: DBS, pallidotomy focused ultrasound thalamotomy, or other experimental neurosurgical procedure
Chronic immunosuppressive therapy

What this trial measures

  • Change from baseline to Month 18 on PD Motor Diary18 months

    Normalized Good ON time per Hauser Diary