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Recruiting NCT07777484

An Unblinded, Single Arm, Pilot Observational Study to Test the Safety, Tolerability, Immunogenicity and the Biological Effects of TRB-001 Vaccination in Individuals Who Have Previously Undergone aSyn Immunotherapy

Conditions: Parkinson's Disease

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 6
Sponsor: Tridem Bioscience FlexCo

Location: PROSENEX Study Centre at the ATOMOS Klinik Währing Vienna

Summary

An unblinded, single arm, pilot observational study to test the safety, tolerability, immunogenicity and the biological effects of TRB-001 vaccination in individuals who have previously undergone aSyn immunotherapy

Eligibility Criteria

Inclusion Criteria: * At least 18-years of age * Female or male with previous treatment with active aSyn immunotherapy * Parkinson's disease diagnosis (any stage) * Understands and agrees to comply with the study procedures and provides written informed consent Exclusion Criteria: * Women of childbearing potential without use of contraception * Women who are pregnant or lactating * Contraindication for MRI or lumbar puncture * Known or suspected allergy, or history of anaphylaxis, to vaccines or their excipients, if considered relevant by the investigator * Presence or history of autoimmune disease or immunodeficiency, if considered relevant by the investigator * Presence of active infectious disease (hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)) * Significant cognitive impairment or clinical dementia, or a Montreal Cognitive Assessment (MoCA) score \

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07777484). StuddyBuddy aggregates publicly available trial information.