A Study of AAV2-GDNF in Adults With Moderate Parkinson's Disease (REGENERATE-PD)
NCT ID: NCT06285643
Last Updated: 2025-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
127 participants
INTERVENTIONAL
2024-06-11
2028-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
GDNF Gene Therapy for Parkinson's Disease
NCT04167540
Study of AAV-GAD Gene Transfer Into the Subthalamic Nucleus for Parkinson's Disease
NCT00643890
AAV2-GDNF for Advanced Parkinson s Disease
NCT01621581
A Double-blind Study to Evaluate the Safety of Glutamic Acid Decarboxylase Gene Transfer in Parkinson's Participants
NCT05603312
A Study of AAV-hAADC-2 in Subjects With Parkinson's Disease
NCT00229736
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
AAV2-GDNF
AAV2-GDNF gene therapy
Bilateral image-guided infusion of AAV2-GDNF into putamen, single dose
Control Surgery
control surgery
Bilateral partial burr/twist holes without dural penetration
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
AAV2-GDNF gene therapy
Bilateral image-guided infusion of AAV2-GDNF into putamen, single dose
control surgery
Bilateral partial burr/twist holes without dural penetration
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. Male and female adults 45-75 years of age inclusive, at the time of signing of informed consent Type of Subject and Disease Characteristics
2. Diagnosed with Parkinson's disease in the past 4-10 years (inclusive) as defined by the following:
1. Presence of bradykinesia PLUS any of the following:
* 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 Criteria
* 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
45 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bayer
INDUSTRY
AskBio Inc
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UCI Alpha Clinic (Neurology)
Irvine, California, United States
Loma Linda University (Neurology)
Loma Linda, California, United States
Loma Linda University (Surgical)
Loma Linda, California, United States
University of California San Francisco (Neurology)
San Francisco, California, United States
University of San Francisco (Surgical)
San Francisco, California, United States
CenExel Rocky Mountain Clinical Research (Neurology)
Englewood, Colorado, United States
Georgetown University (Neurology)
Washington D.C., District of Columbia, United States
Parkinson's Disease and Movement Disorders Center of Boca Raton (Neurology)
Boca Raton, Florida, United States
Parkinson's Disease Treatment Center of Southwest Florida (Neurology)
Port Charlotte, Florida, United States
Emory University (Surgical)
Atlanta, Georgia, United States
Rush University Medical Center (Neurology)
Chicago, Illinois, United States
University of Kansas Medical Center (Neurology)
Kansas City, Kansas, United States
Massachusetts General Hospital (Neurology)
Boston, Massachusetts, United States
Massachusetts General Hospital (Surgical)
Boston, Massachusetts, United States
Michigan State University (Neurology)
East Lansing, Michigan, United States
Quest Research Institute (Neurology)
Farmington Hills, Michigan, United States
Cleveland Clinic Lou Ruvo (Neurology)
Las Vegas, Nevada, United States
University of North Carolina (Neurology)
Chapel Hill, North Carolina, United States
Duke Neurosurgery (Surgical)
Durham, North Carolina, United States
Duke University (Neurology)
Durham, North Carolina, United States
Ohio State University (Surgical)
Columbus, Ohio, United States
University of Pennsylvania (Neurology)
Philadelphia, Pennsylvania, United States
Vanderbilt University (Neurology)
Nashville, Tennessee, United States
Houston Methodist (Neurology)
Houston, Texas, United States
Houston Methodist (Surgical)
Houston, Texas, United States
EvergreenHealth Research Department (Neurology)
Kirkland, Washington, United States
University of Wisconsin (Neurology)
Madison, Wisconsin, United States
Charité - Universitätsmedizin Berlin (Surgical)
Berlin, , Germany
Philipps-Universität Marburg (Neurology)
Marburg, , Germany
Universitätsklinikum Tübingen (Neurology)
Tübingen, , Germany
Universitätsklinikum Tübingen (Surgical)
Tübingen, , Germany
Universitätsklinikum Würzburg (Neurology)
Würzburg, , Germany
Copernicus Podmiot Leczniczy, Szpital św. Wojciecha (Neurology)
Gdansk, , Poland
Specjalistyczna Praktyka Lekarska Prof. Grzegorz Opala (Neurology)
Katowice, , Poland
Mazowiecki Szpital Bródnowski (Neurology)
Warsaw, , Poland
Mazowiecki Szpital Bródnowski (Surgical)
Warsaw, , Poland
Samodzielny Publiczny Szpital Kliniczny im. Prof. W. Orłowskiego CMKP (Neurology)
Warsaw, , Poland
North Bristol NHS Trust - Southmead Hospital (Neurology)
Bristol, , United Kingdom
University Hospital of Wales (Surgical)
Cardiff, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Role: primary
Role: primary
Neepa J. Patel, MD
Role: primary
Related Links
Access external resources that provide additional context or updates about the study.
Nurse Navigator Service for Potential Participants
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ASK-PD5-CS201
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.