NCT06402838

A Study to Evaluate the Safety and Biomarker Effects of RO7269162 in Participants at Risk for or at the Prodromal Stage of Alzheimer's Disease (AD)

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 256 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 60 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial is recruiting people who either are at risk of AD - have build-up of beta-amyloid, but have no clinical symptoms, or with a diagnosis of mild cognitive impairment. People can take part if they have a certain level of plaques (beta-amyloid) in the brain, shown by a positron emission tomography (PET) scan, a medical imaging technique in which tracers are injected to visualize specific pathological processes in the brain. People who take part in this clinical trial (participants) will be given RO7269162 OR placebo for up to about 1 and a half years. The clinical trial team will see them every 3 weeks in the first 3 months and then every 6 weeks until the end of the trial. These hospital visits will include checks to see how the participant responds to the treatment and any side effects they may have. The total time of participation in the clinical trial will be 90 weeks.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	RO7269162	Participants will receive daily doses (one of three dose levels) of RO7269162 for up to 72 weeks.
DRUG	Placebo	Participants will receive daily doses of placebo for up to 72 weeks.

Timeline

• Start date: 2024-05-02
• Primary completion: 2026-11-19
• Completion: 2026-11-19
• First posted: 2024-05-07
• Last updated: 2026-02-18

Locations

47 sites across 9 countries: Chile, Denmark, France, Germany, Italy, Poland, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study