A Study to Investigate the Safety and Effectiveness of SAR448851 in Participants With Early Alzheimer's Disease
Start Date
7/28/2026
Completion Date
7/31/2029
Summary
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.
Eligibility Criteria
Age Range: 55 years to 85 years
Interventions
SAR448851
Placebo
Conditions
Locations
Oakland Clinical- Site Number : 8400010
Oakland, California 94609
United States
Aqualane Clinical Research- Site Number : 8400001
Naples, Florida 34105
United States
Charter Research - Lady Lake- Site Number : 8400004
The Villages, Florida 32162
United States
Boston Center for Memory - Newton- Site Number : 8400007
Newton, Massachusetts 02459
United States
The Cognitive and Research Center of New Jersey - Springfield- Site Number : 8400005
Springfield, New Jersey 07081
United States
Summit Research Network - Portland - Northwest Vaughn Street- Site Number : 8400002
Portland, Oregon 97210
United States
Flourish Research - Keystone Clinical Studies- Site Number : 8400003
Plymouth Meeting, Pennsylvania 19462
United States
Kerwin Medical Center- Site Number : 8400006
Dallas, Texas 75231
United States
Investigational Site Number : 0360001
Macquarie Park, New South Wales 2113
Australia
Investigational Site Number : 0360004
Melbourne, Victoria 3004
Australia
Investigational Site Number : 3920001
Kurashiki, Okayama-ken 701-0813
Japan