GDNF Gene Therapy for Parkinson's Disease

Recruiting in Palo Alto (17 mi)

+2 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Brain Neurotherapy Bio, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?The objective of this Phase 1b investigation is to evaluate the safety and potential clinical effect of AAV2-GDNF delivered to the putamen in subjects with either a recent or a long-standing diagnosis of PD.

Eligibility Criteria

This trial is for adults aged 35-75 with Parkinson's Disease (PD), diagnosed within the last 5 years with mild to moderate symptoms or at least 4 years ago with moderate to severe symptoms. Participants must respond to levodopa treatment, not have atypical parkinsonism, severe dyskinesia, dementia, psychosis, substance abuse issues or severe depression. They can't have had prior brain surgery or be on investigational drugs.

Inclusion Criteria

I was diagnosed with Parkinson's disease over 4 years ago and have moderate to severe symptoms.

I was diagnosed with Parkinson's disease recently.

I am between 35 and 75 years old.

+4 more

Exclusion Criteria

I experience severe involuntary movements.

I have a history of cancer or medical conditions that could make surgery risky.

Currently taking a medication that is still being tested and not approved for general use.

+4 more

Participant Groups

The study tests AAV2-GDNF gene therapy delivered to a part of the brain called putamen in people with PD. It aims to assess safety and potential benefits of this treatment for those newly diagnosed or living long-term with PD.

2Treatment groups

Experimental Treatment

Group I: Later stage PDExperimental Treatment1 Intervention

Group II: Earlier stage PDExperimental Treatment1 Intervention