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

NCT06285643

RecruitingPhase 2

Sponsor: AskBio Inc

Conditions: Parkinson Disease

Interventions: AAV2-GDNF gene therapy, control surgery

Countries: United States, Germany, Poland, United Kingdom

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.

Eligibility overview

Sex: ALL

Age: 45 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

Age

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:

* 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
Locations (46)
  • Phoenix, Arizona, United States
  • Irvine, California, United States
  • Loma Linda, California, United States
  • Loma Linda, California, United States
  • San Francisco, California, United States
  • San Francisco, California, United States
  • Englewood, Colorado, United States
  • Washington D.C., District of Columbia, United States
  • Boca Raton, Florida, United States
  • Gainesville, Florida, United States
  • Miami, Florida, United States
  • Orlando, Florida, United States
  • Port Charlotte, Florida, United States
  • Atlanta, Georgia, United States
  • Chicago, Illinois, United States
  • Kansas City, Kansas, United States
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States
  • East Lansing, Michigan, United States
  • Farmington Hills, Michigan, United States
  • Las Vegas, Nevada, United States
  • New York, New York, United States
  • Chapel Hill, North Carolina, United States
  • Durham, North Carolina, United States
  • Durham, North Carolina, United States
  • Columbus, Ohio, United States
  • Philadelphia, Pennsylvania, United States
  • Nashville, Tennessee, United States
  • Georgetown, Texas, United States
  • Houston, Texas, United States
  • + 16 more on CT.gov