A Study of AAV2-GDNF in Adults With Moderate Parkinson's Disease (REGENERATE-PD)
Recruiting · NCT06285643 · Interventional (participants receive a specific treatment) · Lead sponsor: AskBio Inc
View the official record on ClinicalTrials.gov →Interventions studied
AAV2-GDNF gene therapycontrol surgery
What this trial is about
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 take part
Age range
45 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Age
- 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:
- Rigidity
- Rest tremor
- Postural instability
- 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
Exclusion criteria
- 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
Where it is running
46 locations listed across 20 US states.
- Mayo Clinic - Phoenix, Arizona, United States
- 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
- University of Florida - Gainesville, Florida, United States
- University of Miami - Miami, Florida, United States
- Orlando Health Neuroscience Institute - Orlando, 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
- Columbia University - New York, New York, 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
- Texas Movement Disorder Specialists - Georgetown, Texas, United States
- Houston Methodist (Neurology) - Houston, Texas, United States
- Houston Methodist (Surgical) - Houston, Texas, United States
- University of Utah - Salt Lake City, Utah, United States
- EvergreenHealth Research Department (Neurology) - Kirkland, Washington, United States
- University of Wisconsin (Neurology) - Madison, Wisconsin, United States
- Charité - Universitätsmedizin Berlin (Surgical) - Berlin, Germany
- North Bristol NHS Trust - Southmead Hospital (Neurology) - Bristol, United Kingdom
- University Hospital of Wales (Surgical) - Cardiff, United Kingdom
- Copernicus Podmiot Leczniczy, Szpital św. Wojciecha (Neurology) - Gdansk, Poland
- Specjalistyczna Praktyka Lekarska Prof. Grzegorz Opala (Neurology) - Katowice, Poland
- Philipps-Universität Marburg (Neurology) - Marburg, Germany
- Universitätsklinikum Tübingen (Neurology) - Tübingen, Germany
- Universitätsklinikum Tübingen (Surgical) - Tübingen, Germany
- Mazowiecki Szpital Bródnowski (Neurology) - Warsaw, Poland
- Mazowiecki Szpital Bródnowski (Surgical) - Warsaw, Poland
- Samodzielny Publiczny Szpital Kliniczny im. Prof. W. Orłowskiego CMKP (Neurology) - Warsaw, Poland
- Universitätsklinikum Würzburg (Neurology) - Würzburg, Germany