A Phase 2, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of 48-week SAR448851 treatment followed by open-label extension in participants with early Alzheimer’s disease.

Condition studied

Dementia Alzheimer's type

Investigational medicinal product(s)

Eligibility

Primary endpoint

Part A and optional dose 2 cohort: change from baseline to Week 48 in plasma p-tau217: From baseline to Week 48, Part B: Number of participants experiencing at least one TEAE: from Week 48 to Week 96

Endpoint detail

Part A and optional dose 2 cohort: Change from baseline to Week 48 in plasma glial fibrillary acidic protein (GFAP) and cerebrospinal fluid (CSF) neurogranin (Ng): From baseline to Week 48, Part A and optional dose 2 cohort: Change from baseline to Week 48 in brain amyloid plaque deposition as measured by amyloid positron emission tomography (PET): From baseline to Week 48, Part A and optional dose 2 cohort: Change from baseline to Week 48 in CSF soluble triggering receptor expressed on myeloid cells 2 (sTREM2): From baseline to Week 48, Part A and optional dose 2 cohort: Number of participants with TEAEs and serious adverse events (SAEs), and discontinuations due to TEAEs and SAEs (including laboratory assessments, vital sign measurements, ECGs and the CSSRS): From baseline to Week 48, Part A and optional dose 2 cohort: Number of participants with ARIA-E and ARIA-H assessed by brain MRIs: From baseline to Week 48, Part A and optional dose 2 cohort: Plasma and CSF concentrations of SAR448851: From baseline to Week 48, Part B: Change from baseline to Week 96 in AD biomarkers: plasma p-tau217, plasma GFAP, CSF Ng: From baseline to Week 96, Part B: Change from Week 48 to Week 96 in AD biomarkers: plasma p-tau217, plasma GFAP, CSF Ng: From Week 48 to Week 96