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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
256
Participants will receive daily doses (one of three dose levels) of RO7269162 for up to 72 weeks.
Participants will receive daily doses of placebo for up to 72 weeks.
Centro de Investigación Clínica UC-CICUC
Santiago, Chile
Hospital Clinico Univ de Chile
Santiago, Chile
Aarhus Universitetshospital Skejby
Aarhus N, Denmark
Rigshospitalet, Hukommelsesklinikken
Koebenhavn Oe, Denmark
Groupement Hospitalier Est - Hôpital Neurologique
Bron, France
Hopital B Roger Salengro
Incidence of adverse events (AEs)
Time frame: up to week 72
Change from baseline in brain amyloid load, as measured by amyloid positron emission tomography ( PET) scan
Time frame: Baseline to Week 72
Change from baseline in Aβ37 in cerebrospinal fluid (CSF)
Time frame: Baseline to Week 72
Change from baseline in Aβ38 in CSF
Time frame: Baseline to Week 72
Change from baseline in Aβ40 in CSF
Time frame: Baseline to Week 72
Change from baseline in Aβ42 in CSF
Time frame: Baseline to Week 72
Change from baseline in Aβ40 in plasma
Time frame: Baseline to Week 72
Change from baseline in Aβ42 in plasma
Time frame: Baseline to Week 72
Plasma concentrations of RO7269162
Time frame: Baseline to Week 72
CSF concentrations of RO7269162
Time frame: Baseline to Week 72
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Lille, France
Hôpital de la Timone
Marseille, France
Hôpital Lariboisière
Paris, France
CHU de Rouen Hopital
Rouen, France
Hop Guillaume Et Rene Laennec
Saint-Herblain, France
...and 38 more locations