Recruiting
Phase 2

SAR448851

Sponsor:

Sanofi

Code:

NCT07688213

Conditions

Dementia, Alzheimer's Type

Alzheimer's Disease

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

Interventions

SAR448851

Placebo

Study Details

Brief summary:

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.

Conditions

Dementia, Alzheimer's Type

Alzheimer's Disease

Study ID

NCT07688213

Start date

Jul 28, 2026

Status verified date

Sep, 2026

Completion date

Jul 31, 2029

Anticipated

Primary completion date

Jul 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SAR448851

Participants will receive SAR448851 dose 1 or dose 2 oral daily for 48 weeks

placebo comparator: Placebo

Participants will receive placebo oral daily for 48 weeks

Interventions

SAR448851

Pharmaceutical form: Capsule Route of administration: Oral

Placebo

Pharmaceutical form: Capsule Route of administration: Oral

Primary outcome measure

  • Part A and optional dose 2 cohort: change from baseline to Week 48 in plasma p-tau217 [ Time Frame: From baseline to Week 48 ]
  • Part B: Number of participants with treatment-emergent adverse events (TEAE), including ARIA-E and ARIA-H by brain MRI, laboratory assessments, vital sign measurements, ECGs and the C-SSRS [ Time Frame: From Week 48 to Week 96 ]

Central Contacts and Locations

Central contacts

Trial Transparency email recommended (Toll free for US & Canada)

800-633-1610Contact-US@sanofi.com

Locations

Oakland Clinical- Site Number : 8400010

Recruiting

Oakland, California, United States, 94609

Aqualane Clinical Research- Site Number : 8400001

Recruiting

Naples, Florida, United States, 34105

Charter Research - Lady Lake- Site Number : 8400004

Recruiting

The Villages, Florida, United States, 32162

Boston Center for Memory - Newton- Site Number : 8400007

Recruiting

Newton, Massachusetts, United States, 02459

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

Recruiting

Springfield, New Jersey, United States, 07081

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

Recruiting

Portland, Oregon, United States, 97210

Flourish Research - Keystone Clinical Studies- Site Number : 8400003

Recruiting

Plymouth Meeting, Pennsylvania, United States, 19462

Kerwin Medical Center- Site Number : 8400006

Recruiting

Dallas, Texas, United States, 75231

More Information

Sponsor

Sanofi

Last update posted

Sep 22, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-17. This information was provided to ClinicalTrials.gov by Sanofi on 2026-09-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.