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A Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Multicenter, Parallel-Group Study to Investigate the Safety, Tolerability, and the Effect of RO7269162 on Amyloid and Non-Amyloid Disease-Related Biomarkers following Daily Oral Administration in Participants at Risk for or at the Prodromal Stage of Alzheimer’s Disease

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-506183-13-00
Acronym
BP44745
Enrollment
202
Registered
2024-03-11
Start date
2024-03-29
Completion date
Unknown
Last updated
2025-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer’s Disease

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

DRUGPlacebo RO7269162
DRUGFLORBETABEN (18F)

Sponsors

F. Hoffmann-La Roche AG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime 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

MeasureTime 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

Source: EU CTIS · Data processed: Feb 4, 2026