NCT07688213RecruitingPhase 2
A Study to Investigate the Safety and Effectiveness of SAR448851 in Participants With Early Alzheimer's Disease
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
Source: ClinicalTrials.gov · Last updated 23 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- First submitted
- 30 Jun 2026
- Start date
- 28 Jul 2026
- Primary completion date
- 31 Jul 2029
- Lead sponsor
- Sanofi
- Diseases
- Alzheimer disease
- NCT number
- NCT07688213
- EU CT number
- 2025-524581-14-00
- EudraCT number
- 2025-524581-14
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 160
- From 28 Jul 2026 to the primary completion date, 31 Jul 2029
- 29 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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).
Other
- 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).
Who the study is looking for
- 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.
Age in the registry: 55 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (29)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Ivanhoe | Australia | Recruiting |
| - Coordinator of this site? Confirm its status | Macquarie Park | Australia | Recruiting |
| - Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| - Coordinator of this site? Confirm its status | Ottawa | Canada | Recruiting |
| Kallmann Neurologie Neurologische Praxis Coordinator of this site? Confirm its status | Bamberg | Germany | Recruiting |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Gesundheit Nord gGmbH Klinikverbund Bremen Coordinator of this site? Confirm its status | Bremen | Germany | Recruiting |
| Universitaetsklinikum Koeln AöR Coordinator of this site? Confirm its status | Cologne | Germany | Recruiting |
| Medizinische Hochschule Hannover Coordinator of this site? Confirm its status | Hanover | Germany | Recruiting |
| Barcelonabeta Brain Research Center Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Fundació ACE, Institut Català de Neurociències Aplicades Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario Quironsalud Madrid Coordinator of this site? Confirm its status | Pozuelo de Alarcón | Spain | Recruiting |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Clinica Montecanal S.L. Coordinator of this site? Confirm its status | Zaragoza | Spain | Recruiting |
| - Coordinator of this site? Confirm its status | Bath | United Kingdom | Recruiting |
| - Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| - Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| - Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Kerwin Medical Center- Site Number : 8400006 Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Healthy Brain Clinic- Site Number : 8400011 Coordinator of this site? Confirm its status | Long Beach | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Naples | United States | Recruiting |
| Boston Center for Memory - Newton- Site Number : 8400007 Coordinator of this site? Confirm its status | Newton | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Oakland | United States | Recruiting |
| K2 Medical Research - Orlando - South Orlando Avenue- Site Number : 8400008 Coordinator of this site? Confirm its status | Orlando | United States | Recruiting |
| Flourish Research - Keystone Clinical Studies- Site Number : 8400003 Coordinator of this site? Confirm its status | Plymouth Meeting | United States | Recruiting |
| Summit Research Network - Portland - Northwest Vaughn Street- Site Number : 8400002 Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
| The Cognitive and Research Center of New Jersey - Springfield- Site Number : 8400005 Coordinator of this site? Confirm its status | Springfield | United States | Recruiting |
| Charter Research - Lady Lake- Site Number : 8400004 Coordinator of this site? Confirm its status | The Villages | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.