Study to identify eligible patients with Parkinson's Disease for clinical trial in cell transplant of dopamine producing neurons
Official Title
A Screening Study Assessing Eligibility of Idiopathic Parkinson’s Disease Patients for Potential Future Intraputamenal Transplant Study with a Dopaminergic Precursor Product
Purpose
The purpose of this screening study is to identify eligible patients with Parkinson's Disease for a clinical trial in cell transplantation to a part of the brain called the putamen. The cell transplantation will be of precursors of dopamine producing neurons (the precursors are intended to turn into mature neurons).
In the screening study patients will be evaluated for the following:
- To characterize your Parkinson's Disease symptoms using information from clinical assessments, genetic tests, blood tests, and imaging of the brain.
- Determine if you qualify for a future Phase 1b/2a transplant study to the putamen
- To collect imaging information about dopamine function and brain function in Parkinson's Disease using 2 scans called a F-DOPA PET and a FDG PET
- To study your blood and urine for biomarkers
Could this study be right for you?
Inclusion Criteria (summarized)
- Diagnosis of Idiopathic Parkinson’s Disease
- Currently using anti-parkinsonian medications and experience some benefits from the medications.
- Both sides of your body experience symptoms of Parkinson's Disease
- Not currently pregnant or planning to get pregnant
- Willing and able to avoid deep brain stimulation (DBS) during the course of the study and for at least 18 months after transplantation should the study participant be eligible for the interventional phase
- Willing and able to avoid treatment with continuous apomorphine IV infusions or Duodopa® during the course of the study
Exclusion Criteria (summarized)
- Diagnosis of secondary or atypical parkinsonism.
- Previous infusion therapy or surgery for PD.
- Severe dyskinesia (mild to moderate levadopa induced dyskinesia is acceptable)
- Clinically significant hallucinations requiring antipsychotic use in the previous 6 months.
- Use of dopamine antagonists within 90 days of screening.
- Currently active major depression that is not well controlled
- History of any cancer (other than treated basal or squamous cell carcinoma) within past 3 years
- Current participation in another investigational clinical trial and/or receipt of any investigational medication within 90 days prior to screening.
- Known PD gene mutation or causative variant as informed by genetic testing.
- Unable to have a MRI