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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
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

Full criteria on ClinicalTrials.gov

Sites (29)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
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IvanhoeAustraliaRecruiting
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Macquarie ParkAustraliaRecruiting
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MelbourneAustraliaRecruiting
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OttawaCanadaRecruiting
Kallmann Neurologie Neurologische Praxis
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BambergGermanyRecruiting
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyRecruiting
Gesundheit Nord gGmbH Klinikverbund Bremen
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BremenGermanyRecruiting
Universitaetsklinikum Koeln AöR
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CologneGermanyRecruiting
Medizinische Hochschule Hannover
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HanoverGermanyRecruiting
Barcelonabeta Brain Research Center
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BarcelonaSpainRecruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainRecruiting
Fundació ACE, Institut Català de Neurociències Aplicades
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BarcelonaSpainRecruiting
Hospital Universitario Quironsalud Madrid
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Pozuelo de AlarcónSpainRecruiting
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainRecruiting
Clinica Montecanal S.L.
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ZaragozaSpainRecruiting
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BathUnited KingdomRecruiting
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LondonUnited KingdomRecruiting
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LondonUnited KingdomRecruiting
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LondonUnited KingdomRecruiting
Kerwin Medical Center- Site Number : 8400006
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DallasUnited StatesRecruiting
Healthy Brain Clinic- Site Number : 8400011
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Long BeachUnited StatesRecruiting
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NaplesUnited StatesRecruiting
Boston Center for Memory - Newton- Site Number : 8400007
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NewtonUnited StatesRecruiting
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OaklandUnited StatesRecruiting
K2 Medical Research - Orlando - South Orlando Avenue- Site Number : 8400008
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OrlandoUnited StatesRecruiting
Flourish Research - Keystone Clinical Studies- Site Number : 8400003
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Plymouth MeetingUnited StatesRecruiting
Summit Research Network - Portland - Northwest Vaughn Street- Site Number : 8400002
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PortlandUnited StatesRecruiting
The Cognitive and Research Center of New Jersey - Springfield- Site Number : 8400005
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SpringfieldUnited StatesRecruiting
Charter Research - Lady Lake- Site Number : 8400004
Coordinator of this site? Confirm its status
The VillagesUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.