NCT06285643 A Study of AAV2-GDNF in Adults With Moderate Parkinson's Disease (REGENERATE-PD)
| NCT ID | NCT06285643 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | AskBio Inc |
| Condition | Parkinson Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 127 participants |
| Start Date | 2024-06-11 |
| Primary Completion | 2028-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 127 participants in total. It began in 2024-06-11 with a primary completion date of 2028-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06285643 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, up to 75 Years, studying Parkinson Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06285643 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06285643 currently recruiting?
Yes, NCT06285643 is actively recruiting participants. Contact the research team at askfirst@askbio.com for enrollment information.
Where is the NCT06285643 trial being conducted?
This trial is being conducted at Phoenix, United States, Irvine, United States, Loma Linda, United States, Loma Linda, United States and 11 additional locations.
Who is sponsoring the NCT06285643 clinical trial?
NCT06285643 is sponsored by AskBio Inc. The trial plans to enroll 127 participants.
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