Alzheimer's disease
Conditions
Brief summary
1. Nature, frequency, severity, and timing of AEs, including – for Part 1 only – DLAEs. Significant assessments reported as AEs include clinical laboratory assessments and vital signs, physical and neurological examination, 12-lead ECG, and brain MRI findings (including the occurrence of vasogenic edema and hemorrhage) (Part 1-4), 2. Change from baseline in brain amyloid load, as measured by amyloid PET scan (Part 3)
Detailed description
1. Change from baseline in brain amyloid load, as measured by amyloid PET scan (Part 1, 2 and 4 only), 2. Plasma Concentration of RO7126209 at specified timepoints, 3. CSF concentration of RO7126209, 4. Incidence and titer of anti-RO7126209 ADAs over time
Interventions
Sponsors
F. Hoffmann-La Roche AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Nature, frequency, severity, and timing of AEs, including – for Part 1 only – DLAEs. Significant assessments reported as AEs include clinical laboratory assessments and vital signs, physical and neurological examination, 12-lead ECG, and brain MRI findings (including the occurrence of vasogenic edema and hemorrhage) (Part 1-4), 2. Change from baseline in brain amyloid load, as measured by amyloid PET scan (Part 3) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change from baseline in brain amyloid load, as measured by amyloid PET scan (Part 1, 2 and 4 only), 2. Plasma Concentration of RO7126209 at specified timepoints, 3. CSF concentration of RO7126209, 4. Incidence and titer of anti-RO7126209 ADAs over time | — |
Countries
Poland, Spain
Outcome results
None listed