Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
Eligibility Criteria
- 1. Participants voluntarily agree to participate in this study and sign an Institutional Review Board (IRB)-approved informed consent form (ICF) prior to performing any of the screening procedures.
- 2. Diagnosis of Parkinson's disease (PD) with motor symptom improvement from levodopa, if applicable.
- 3. Less than 5 years from the initial PD diagnosis, at the time of ICF.
- 4. Early-stage PD, with mild symptoms based on standard clinical staging in OFF state.
- 5. Participants who are on immediate-release levodopa-carbidopa/benserazide.
- 6. No active cancer, unless in remission for ≥10 years without ongoing treatment, except fully removed basal cell carcinoma.
- 7. Free of significant health issues that might interfere with study participation.
- 8. Negative screening for illegal drugs (excluding cannabis), with willingness to abstain during the study and avoid cannabis or alcohol effects during visits.
- 1. History of sudden, unexpected PD medication OFF episodes.
- 2. Severe motor complications or disabling symptoms that may impact study involvement.
- 3. Any condition or health concern deemed a safety risk or likely to interfere with study results.
- 4. Severe psychiatric disorders, including psychosis or substance addiction.
- 5. Allergies or sensitivities to specific study-related treatments or substances.
- 6. Any prior history of a severe infusion reaction.
- 7. Pregnancy, breastfeeding, or plans for pregnancy or ova donation during or shortly after the study.
- 8. Recent use of investigational drugs or therapeutic antibodies.
Ages Eligible for Study
50 Years to 80 Years
Sexes Eligible for Study
ALL
Accepts Healthy Volunteers
No