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
Hoffmann-La Roche·Phase 2·ClinicalTrials.gov·drugRecruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
Alzheimer's Disease
Drug/Device/Intervention
RO7269162
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Hoffmann-La Roche
Location
Bron cedex,Paris,Toulouse,Gyeonggi-do,Incheon,Incheon, France,South Korea
Timeline & enrollment
Phase
Phase 2
Start date
May 02, 2024
End date
May 19, 2027
Enrollment
245 participants
Primary outcome

Incidence of adverse events (AEs),Change from baseline in brain amyloid load, as measured by amyloid positron emission tomography ( PET) scan

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.

ICD-10 classifications
Alzheimer diseaseAlzheimer disease, unspecifiedOther Alzheimer diseaseDementia in Alzheimer diseaseDementia in Alzheimer disease, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06402838
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06402838 through Pure Global AI's free database. This Phase 2 trial is sponsored by Hoffmann-La Roche and is currently Recruiting. The study focuses on Alzheimer's Disease. Target enrollment is 245 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.