UB-312 Vaccine for Parkinson's & Multiple System Atrophy
Trial Summary
Will I have to stop taking my current medications?
The trial requires that participants have stable treatment of permitted antiparkinsonian medications for at least 30 days before the first study drug administration, or 60 days for MAO-B inhibitors, and remain stable throughout the study. Some medications are prohibited, so you may need to adjust your current medications based on the trial's requirements.
What data supports the effectiveness of the UB-312 vaccine for Parkinson's and Multiple System Atrophy?
Is the UB-312 vaccine safe for humans?
A first-in-human study of UB-312, a vaccine targeting alpha-synuclein, suggests it is generally safe, though specific safety data from this study is not detailed. Another study on similar vaccines for multiple system atrophy reported mild to moderate side effects, mostly injection-site reactions, indicating a good safety profile.34678
How is the UB-312 treatment different from other treatments for Parkinson's and Multiple System Atrophy?
UB-312 is a vaccine that targets alpha-synuclein, a protein involved in Parkinson's and Multiple System Atrophy, aiming to prevent its harmful accumulation in the brain and gut. This approach is unique because it uses the body's immune system to produce antibodies against the toxic forms of alpha-synuclein, potentially modifying the disease process rather than just alleviating symptoms.34679
What is the purpose of this trial?
This trial tests a new vaccine called UB-312, which aims to help patients with MSA and PD by teaching their immune systems to attack harmful brain proteins.
Research Team
Horacio Kaufmann, MD
Principal Investigator
NYU Langone Health
Eligibility Criteria
This trial is for adults aged 40-75 with Parkinson's Disease or Multiple System Atrophy, confirmed by specific criteria. Participants must have a certain cognitive score, be within a specified weight range, and agree to use contraception if of childbearing potential. They should not have had recent investigational drug use, significant allergies, autoimmune disorders, or conditions that could interfere with the study.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive active treatment and placebo injections over a period of 97 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Placebo Injection
- UB-312 Injection
Find a Clinic Near You
Who Is Running the Clinical Trial?
NYU Langone Health
Lead Sponsor