ClinicaliQ Trial Snapshot
- A Study of AAV2-GDNF in Adults With Moderate Parkinson’s Disease (REGENERATE-PD) — Recruiting • Phase II • Neurology • NCT06285643.
- What is being tested: AAV2-GDNF is a gene therapy delivered surgically to the putamen (a key brain region affected in Parkinson's Disease) to potentially restore dopamine-producing nerve function through glial cell line-derived neurotrophic factor expression.
- Patient eligibility overview: Adults with moderate Parkinson's Disease are enrolled in this randomized, double-blinded Phase 2 trial, with surgical delivery requiring careful patient selection based on disease stage and ability to tolerate neurosurgical intervention.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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 Snapshot
- : 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
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.