Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SAR448851 · 1 trial · 2 indications
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)
| Arm | Type | Description |
|---|---|---|
| SAR448851 | EXPERIMENTAL | Participants will receive SAR448851 dose 1 or dose 2 oral daily for 48 weeks |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo oral daily for 48 weeks |
| Name | Type | Description |
|---|---|---|
| SAR448851 | DRUG | Pharmaceutical form: Capsule Route of administration: Oral |
| Placebo | DRUG | Pharmaceutical form: Capsule Route of administration: Oral |
Inclusion Criteria: * Participant must be 55 to 85 years (inclusive) of age, at the time of signing the informed consent. * Diagnosis of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) (National Institute on Aging-Alzheimer's Association \[NIA-AA\] Stage 3) or mild AD dementia (NIA-...
SAR448851 is an investigational small molecule drug being developed by Sanofi for the treatment of early Alzheimer's disease. It is currently in Phase 2 clinical development and has not been approved for any indication. The drug is being studied for its safety and effectiveness in participants with early Alzheimer's disease.
SAR448851 is being studied for the treatment of Dementia, Alzheimer's Type, specifically in participants with early Alzheimer's disease. It is an investigational therapy and is not approved for any use. The ongoing Phase 2 trial is evaluating its safety and effectiveness in this patient population.
SAR448851 is being developed by Sanofi, a global pharmaceutical company. Sanofi trades on the Nasdaq under the ticker symbol SNY. The company is responsible for the clinical development of this investigational small molecule for early Alzheimer's disease.
SAR448851 is in Phase 2 clinical development. The ongoing trial is a randomized, double-blind, placebo-controlled study. It is currently recruiting participants and has not yet been completed. The drug remains investigational and has not received regulatory approval for any indication.
SAR448851 is being evaluated in a Phase 2 clinical trial identified as NCT07688213. The study is titled "A Study to Investigate the Safety and Effectiveness of SAR448851 in Participants With Early Alzheimer's Disease." It is currently recruiting and plans to enroll 160 participants across the United States, Australia, and Japan.
The Phase 2 trial NCT07688213 is a randomized, double-blind, placebo-controlled study evaluating SAR448851 in participants with early Alzheimer's disease. It plans to enroll 160 participants aged 55 years and older, of all sexes, who are not healthy volunteers. The trial is recruiting in the United States, Australia, and Japan.