Alzheimer’s Disease
Conditions
Brief summary
1. Nature, incidence, severity, and outcome of AEs, 2. Changes from baseline in vital signs, ECG parameters, Columbia-Suicide Severity Rating Scale (C-SSRS) and safety laboratory findings, 3. Change from baseline in brain amyloid load, as measured by amyloid PET scan
Detailed description
1. Change from baseline in Aβ37, Aβ38, Aβ40 and Aβ42 in CSF and Aβ40 and Aβ42 in plasma, 2. Plasma concentrations of RO7269162 (and its metabolite[s] as appropriate), 3. CSF concentrations of RO7269162 (and its metabolite[s] as appropriate)
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, incidence, severity, and outcome of AEs, 2. Changes from baseline in vital signs, ECG parameters, Columbia-Suicide Severity Rating Scale (C-SSRS) and safety laboratory findings, 3. Change from baseline in brain amyloid load, as measured by amyloid PET scan | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change from baseline in Aβ37, Aβ38, Aβ40 and Aβ42 in CSF and Aβ40 and Aβ42 in plasma, 2. Plasma concentrations of RO7269162 (and its metabolite[s] as appropriate), 3. CSF concentrations of RO7269162 (and its metabolite[s] as appropriate) | — |
Countries
Denmark, France, Germany, Italy, Poland, Spain
Outcome results
None listed