A Phase 2 interventional study of SAR448851 and Placebo in Dementia, Alzheimer's Type and Alzheimer's Disease, sponsored by Sanofi. Recruiting at 11 sites in 3 countries. Open to participants aged 55 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Sanofi · Phase 2, Interventional, and Treatment
This is a randomized, placebo-controlled Phase 2 study to evaluate the efficacy and safety of SAR448851 in early Alzheimer's disease (AD) participants. The purpose of this study is to measure efficacy and safety with once daily oral SAR448851 compared to placebo in participants with mild cognitive impairment due to AD or mild AD dementia and with evidence of cerebral amyloid pathology.
This Phase 2 study has 2 parts: Part A is a randomized, double-blind, parallel-group, placebo-controlled study with SAR448851 oral once daily. Part B is an open-label extension. All participants who complete Part A may continue to Part B. An optional dose 2 cohort will be considered to evaluate the efficacy and safety of SAR448851 dose 2 oral once daily.
The study duration will be up to 111 weeks for Part A and B, and up to 63 weeks for the dose 2 cohort. The treatment duration will be up to 96 weeks for Part A and B, and up to 48 weeks for the dose 2 cohort.
Up to 160 participants will be included in this study.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's planned enrollment of 160 is above the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Participants will receive SAR448851 dose 1 or dose 2 oral daily for 48 weeks
Drug: SAR448851
Participants will receive placebo oral daily for 48 weeks
Drug: Placebo
Pharmaceutical form: Capsule Route of administration: Oral
Pharmaceutical form: Capsule Route of administration: Oral
Part A and optional dose 2 cohort: change from baseline to Week 48 in plasma p-tau217
Time frame: From baseline to Week 48
Part B: Number of participants with treatment-emergent adverse events (TEAE), including ARIA-E and ARIA-H by brain MRI, laboratory assessments, vital sign measurements, ECGs and the C-SSRS
Number of participants experiencing at least one treatment-emergent adverse event (TEAE), including amyloid-related imaging abnormalities with edema (ARIA-E) and amyloid-related imaging abnormalities with hemosiderin (ARIA-H) by brain magnetic resonance imaging (MRI), laboratory assessments, vital sign measurements, electrocardiograms (ECGs) and the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: From Week 48 to Week 96
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)
Time frame: 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)
Time frame: 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)
Time frame: 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 C-SSRS)
Number of participants experiencing at least one treatment-emergent adverse event (TEAE), serious adverse event (SAE) or discontinuation due to TEAEs and SAEs (including laboratory assessments, vital sign measurements, electrocardiograms \[ECGs\] and the Columbia-Suicide Severity Rating Scale \[C-SSRS\])
Time frame: 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
Number of participants with amyloid-related imaging abnormalities with edema (ARIA-E) and amyloid-related imaging abnormalities with hemosiderin (ARIA-H) assessed by brain magnetic resonance imaging (MRI). ARIA event: adverse event causing brain swelling or bleeding that requires close monitoring.
Time frame: From baseline to Week 48
Part A and optional dose 2 cohort: Plasma and CSF concentrations of SAR448851
Time frame: From baseline to Week 48
Part B: Change from baseline to Week 96 in AD biomarkers: plasma p-tau217, plasma GFAP, CSF Ng
Change in Alzheimer's disease (AD) biomarkers: plasma p-tau217, plasma glial fibrillary acidic protein (GFAP) and cerebrospinal fluid (CSF) neurogranin (Ng)
Time frame: From baseline to Week 96
Part B: Change from Week 48 to Week 96 in AD biomarkers: plasma p-tau217, plasma GFAP, CSF Ng
Change in Alzheimer's disease (AD) biomarkers: plasma p-tau217, plasma glial fibrillary acidic protein (GFAP) and cerebrospinal fluid (CSF) neurogranin (Ng)
Time frame: From Week 48 to Week 96
Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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