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

Study of an Investigational Study Drug for Early Alzheimer’s Disease

Age
55 years - 85 years
Gender
All
Phase
Phase 2
Participants needed
160
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Study Overview

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

You may be eligible for this study if you meet the following criteria:

  • Conditions: Dementia, Alzheimer's Type, Alzheimer's Disease
  • Age: 55 years - 85 years
  • Gender: All

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.

The purpose of this research study is to learn about the effects and safety of an investigational study drug in people with early Alzheimer’s disease. This study is for adults who have mild thinking and memory problems due to Alzheimer’s disease (mild cognitive impairment) or mild Alzheimer’s dementia, and who show signs of amyloid in the brain.

Participants will take the investigational study drug or a placebo by mouth once a day. A placebo looks like the investigational study drug but does not contain active medication. People who finish the first part of the study may be able to continue into a later part where everyone receives the investigational study drug. Some participants may be considered for a different dose of the investigational study drug taken once a day.

Who can participate:
Adults ages 55 to 85 with early Alzheimer’s disease may be able to participate if they:

  • Have mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s dementia
  • Have evidence of amyloid in the brain shown by an amyloid PET scan
  • Have a study partner (age 18 or older) who has known them for at least one year and has at least 8 hours of contact per week
  • Have not taken anti-amyloid immunotherapy or certain other Alzheimer’s-related immune treatments in the past
  • Are not currently taking blood-thinner (anticoagulant) medicines
  • Do not have a history of certain other major brain or nerve diseases (such as Parkinson’s disease, epilepsy or repeated seizures, Lewy body dementia, or multiple sclerosis)

Study timeline and visits:
Participation lasts up to 111 weeks for the main study. Participation may last up to 63 weeks for people in the different-dose group.

Updated on 15 Sep 2026. Study ID: NCT07688213

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