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

NCT ID: NCT07688213
Registry status: Recruiting
Study type: Interventional
Phase: Phase 2
Sponsor: Sanofi
Conditions: Alzheimer's Disease, Dementia, Alzheimer's Type

Overview

ClinicalTrials.gov lists this study as Recruiting.

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

Enrollment: 160 participants (Estimated).

What is being studied

Drug: Placebo
Drug: SAR448851

Who may be eligible

Ages: 55 Years to 85 Years
Sex: All
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following eligibility criteria.

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-AA Stage 4). * Have a global Clinical Dementia Rating (CDR) score 0.5 to 1.0 and a CDR-Memory Box score ≥ 0.5 at screening. * Have a study partner who must provide separate written informed consent at screening. Study partner should be \>18 years of age, have known participant for at least 1 year, and have a minimum of 8 hours per week contact with participant. * The participant has evidence of cerebral amyloid pathology confirmed by positive visual read on amyloid positron emission tomography (PET) at screening. Exclusion Criteria: * The participant has any history of significant neurological disease including but not limited to, frontotemporal dementia, Lewy body dementia, Huntington's disease, serious infection of the brain, Parkinson's disease, multiple concussions, multiple sclerosis, or epilepsy or recurrent seizures (except febrile childhood seizures). * The participant has evidence of more than 4 microhemorrhages (\<10 mm in diameter) or superficial siderosis. * The participant carries two copies of the apolipoprotein-E epsilon 4 (APOE4) allele (APOE4/4). * The participant is currently receiving or has previously received any anti-amyloid immunotherapy (including, but not limited to, aducanumab, lecanemab, or donanemab) or triggering receptor expressed on myeloid cells 2 (TREM-2) targeting therapy. * The participant is currently receiving anticoagulant therapies. * The participant has had malignancy in the 3 years prior to Screening, excluding basal cell carcinoma, squamous cell carcinoma of the skin, melanoma in situ, Stage 1 or 2 prostate cancer, fully resected renal cell cancers, or cervical carcinoma in situ that has been successfully treated. The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Study locations

11 study locations are listed.

Recruiting site status is explicitly provided for 11 locations; 11 are listed as Recruiting.

Countries: Australia, Japan, United States

New South Wales, Australia: 1
Victoria, Australia: 1
Okayama-ken, Japan: 1
California, United States: 1
Florida, United States: 2
Massachusetts, United States: 1
New Jersey, United States: 1
Oregon, United States: 1
Pennsylvania, United States: 1
Texas, United States: 1

Sample of listed locations

Investigational Site Number : 0360001 — Macquarie Park, New South Wales, 2113, Australia — Recruiting
Investigational Site Number : 0360004 — Melbourne, Victoria, 3004, Australia — Recruiting
Investigational Site Number : 3920001 — Kurashiki, Okayama-ken, 701-0813, Japan — Recruiting
Oakland Clinical- Site Number : 8400010 — Oakland, California, 94609, United States — Recruiting
Aqualane Clinical Research- Site Number : 8400001 — Naples, Florida, 34105, United States — Recruiting
Charter Research - Lady Lake- Site Number : 8400004 — The Villages, Florida, 32162, United States — Recruiting
Boston Center for Memory - Newton- Site Number : 8400007 — Newton, Massachusetts, 02459, United States — Recruiting
The Cognitive and Research Center of New Jersey - Springfield- Site Number : 8400005 — Springfield, New Jersey, 07081, United States — Recruiting
Summit Research Network - Portland - Northwest Vaughn Street- Site Number : 8400002 — Portland, Oregon, 97210, United States — Recruiting
Flourish Research - Keystone Clinical Studies- Site Number : 8400003 — Plymouth Meeting, Pennsylvania, 19462, United States — Recruiting
Kerwin Medical Center- Site Number : 8400006 — Dallas, Texas, 75231, United States — Recruiting

Study details

Start date: July 28, 2026
Primary completion date: July 31, 2029
Completion date: July 31, 2029
First posted: July 7, 2026

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT07688213
Registry last updated: September 22, 2026
QualifiedStudies registry data refreshed: September 28, 2026
QualifiedStudies record fetched: September 28, 2026

View NCT07688213 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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