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RecruitingPhase 2

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

Sanofi · NCT07688213

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 55–85 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
160
US sites recruiting
10
Study start
July 28, 2026
Record last updated
October 23, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: SAR448851; Placebo

Conditions: Dementia, Alzheimer's Type; Alzheimer's Disease

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

  • Healthy Brain Clinic- Site Number : 8400011

    Long Beach, CA 90804

  • Oakland Clinical- Site Number : 8400010

    Oakland, CA 94609

  • Aqualane Clinical Research- Site Number : 8400001

    Naples, FL 34105

  • K2 Medical Research - Orlando - South Orlando Avenue- Site Number : 8400008

    Orlando, FL 32751

  • Charter Research - Lady Lake- Site Number : 8400004

    The Villages, FL 32162

  • Boston Center for Memory - Newton- Site Number : 8400007

    Newton, MA 02459

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

    Springfield, NJ 07081

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

    Portland, OR 97210

  • Flourish Research - Keystone Clinical Studies- Site Number : 8400003

    Plymouth Meeting, PA 19462

  • Kerwin Medical Center- Site Number : 8400006

    Dallas, TX 75231

Study contacts (from the official record)

  • Trial Transparency email recommended (Toll free for US & Canada) · 800-633-1610 · Contact-US@sanofi.com
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A Study to Investigate the Safety and Effectiveness of SAR448851… (NCT07688213) | Bored Studies