A Study of AAV2-GDNF in Adults With Moderate Parkinson's Disease (REGENERATE-PD)
NCT ID: NCT06285643
Last Updated: 2025-11-14
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
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RECRUITING
PHASE2
87 participants
INTERVENTIONAL
2024-06-11
2027-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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
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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
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Eligibility Criteria
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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 regiment 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
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Bayer
INDUSTRY
AskBio Inc
INDUSTRY
Responsible Party
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Locations
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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
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Central Contacts
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Facility Contacts
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Role: primary
Julie Lacanlale
Role: primary
Aaron Daley
Role: primary
Role: primary
Luke Lovelace
Role: primary
Lauren Salmon
Role: primary
Neepa J. Patel, MD
Role: primary
Sarina Fay
Role: primary
Nisha Kabir
Role: primary
Leigh Whittet
Role: primary
Denise Morgott
Role: primary
Liliana Dumitrescu
Role: primary
Hans Nettesheim
Role: primary
Karen White-Tong
Role: primary
Neda Almassi
Role: primary
Haley Kling
Role: primary
Daniel Arnaud Dominguez
Role: primary
Gowri Rajendran
Role: primary
Amy Nagel
Role: primary
Stefanie Spriewald
Role: primary
Gabriele König
Role: primary
Christine Leypold
Role: primary
Anna Roszmann
Role: primary
Magdalena Łyniewska
Role: primary
Joanna Kralka
Role: primary
Marta Piaścik-Gromada
Role: primary
Dominika Kruszynska
Role: primary
Related Links
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Nurse Navigator Service for Potential Participants
Other Identifiers
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ASK-PD5-CS201
Identifier Type: -
Identifier Source: org_study_id