Clinical Study to Test the Safety of CDNF by Brain Infusion in Patients With Parkinson's Disease

Exclusion Criteria

• •1. Diagnosed with atypical parkinsonism or any known secondary parkinsonian syndrome.
• •2. Signs or symptoms suggestive of atypical parkinsonian syndrome.
• •3. Drug-resistant rest tremor.
• •4. Prior neurosurgical treatment for PD, including lesioning or deep brain stimulation
• •5. Significant neurological disorder other than PD including clinically significant head trauma, cerebrovascular disease, epilepsia, CSF shunt or other implanted CNS device
• •6. Presence of significant depression as defined as a BDI score ≥ 20
• •7. Current psychosis requiring therapy.
• •8. Presence of clinically significant impulse control disorder ((QUIP-RS) score \> 20), or, presence of dopamine dysregulation syndrome.
• •9. MoCA score \< 24.
• •10. Use within 3 months of planned catheter insertion of concomitant medications known to affect PD symptoms other than prescribed PD therapy.
• •11. Any medical condition, which might impair outcome measure assessments or safety measures including ability to undergo MRI or DAT-PET.
• •12. Hypersensitivity or allergy to gadolinium or to any of excipients of macrocyclic GBCA used for the surgical planning MRI.
• •13. Screening and/or planning MRI demonstrating any abnormality, which would suggest an alternative cause for patient's parkinsonism or preclude neurosurgery.
• •14. Any medical condition that would put the patient at undue risk from surgical treatment or chronic implants including but not limited to bleeding disorders, chronic infections, or immunosuppressive illness
• •15. History within the last 5 years of cancer with the exception of basal cell carcinoma of the skin
• •16. History of drug or alcohol abuse within 2 years of screening
• •17. Use of any investigational drug or device within 90 days of screening
• •18. Active breastfeeding