ClinicalTrials.gov ID: NCT06285643
Ages Eligible: 45-75 years
Sexes Eligible: All
Study Phase: Interventional
Study Completion (Estimated): End of 2026
Principal Investigator: Dr. Pinky Agarwal
Contact Information:
EvergreenHealth Research Department
425-899-5385
EvergreenResearch@evergreenhealthcare.org
Summary:
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 Criteria:
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
