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