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New treatment option for Parkinson Disease
Official title A Study of AAV2-GDNF in Adults With Moderate Parkinson's Disease (REGENERATE-PD)
ClinicalTrials.gov ID: NCT06285643
What this study is testing
What is AAV2-GDNF gene therapy?
AAV2-GDNF gene therapy is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for parkinson disease.
Also referred to as Biological.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 75
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility criteria
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Irvine, California, United States
- Loma Linda, 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
- 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
+ 18 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Irvine, California, United States; Loma Linda, California, United States; San Francisco, California, United States; Englewood, Colorado, United States; Washington D.C., District of Columbia, United States and 32 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.