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RECRUITING
NCT07688213
PHASE2

A Study to Investigate the Safety and Effectiveness of SAR448851 in Participants With Early Alzheimer's Disease

Sponsor: Sanofi

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

55 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2026-07-28

Completion Date

2029-07-31

Last Updated

2026-09-22

Healthy Volunteers

No

Interventions

DRUG

SAR448851

Pharmaceutical form: Capsule Route of administration: Oral

DRUG

Placebo

Pharmaceutical form: Capsule Route of administration: Oral

Locations (11)

Oakland Clinical- Site Number : 8400010

Oakland, California, United States

Aqualane Clinical Research- Site Number : 8400001

Naples, Florida, United States

Charter Research - Lady Lake- Site Number : 8400004

The Villages, Florida, United States

Boston Center for Memory - Newton- Site Number : 8400007

Newton, Massachusetts, United States

The Cognitive and Research Center of New Jersey - Springfield- Site Number : 8400005

Springfield, New Jersey, United States

Summit Research Network - Portland - Northwest Vaughn Street- Site Number : 8400002

Portland, Oregon, United States

Flourish Research - Keystone Clinical Studies- Site Number : 8400003

Plymouth Meeting, Pennsylvania, United States

Kerwin Medical Center- Site Number : 8400006

Dallas, Texas, United States

Investigational Site Number : 0360001

Macquarie Park, New South Wales, Australia

Investigational Site Number : 0360004

Melbourne, Victoria, Australia

Investigational Site Number : 3920001

Kurashiki, Okayama-ken, Japan