Early stages of idiopathic Parkinson's Disease
Conditions
Brief summary
Safety and Tolerability: Adverse events; physical and neurological examination results; global assessment of tolerability; vital signs; brain MRI; ectrocardiogram; routine laboratory tests (eg, hematology and biochemistry evaluation) in blood and urine; suicidality as measured with the Columbia Suicide Severity Rating Scale., Immunogenicity: Antibody response induced by the study vaccine.
Detailed description
Absolute levels and change from baseline in a-syn related fluid biomarkers, including pathogenic a-syn oligomer species and/or differentially phosphorylated synuclein species, in any collected blood and/or CSF sample., Change from baseline in DaT-SPECT at 48 weeks and 100 weeks., Absolute values and change from baseline in the MDS-UPDRS Part III score over 100 weeks.
Interventions
DRUGACI-7104.056
DRUGPlacebo (PBS-ALH02)
DRUGadjuvanted solution matching the study vaccine formulation
Sponsors
AC Immune S.A.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and Tolerability: Adverse events; physical and neurological examination results; global assessment of tolerability; vital signs; brain MRI; ectrocardiogram; routine laboratory tests (eg, hematology and biochemistry evaluation) in blood and urine; suicidality as measured with the Columbia Suicide Severity Rating Scale., Immunogenicity: Antibody response induced by the study vaccine. | — |
Secondary
| Measure | Time frame |
|---|---|
| Absolute levels and change from baseline in a-syn related fluid biomarkers, including pathogenic a-syn oligomer species and/or differentially phosphorylated synuclein species, in any collected blood and/or CSF sample., Change from baseline in DaT-SPECT at 48 weeks and 100 weeks., Absolute values and change from baseline in the MDS-UPDRS Part III score over 100 weeks. | — |
Countries
Germany, Spain
Outcome results
None listed