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

Purpose

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

Eligibility

Eligible Ages
Between 55 Years and 85 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Part A and optional dose 2 cohort is a randomized, double-blind, parallel-group, placebo-controlled study with 2 arms in each cohort. Part B is an open-label extension.
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Part A and optional dose 2 cohort is a double-blind study in which participants, care providers, Treating Investigator, independent rater, clinical site staff, and Sponsor's clinical trial team members are blinded to study intervention. Part B is an open-label extension.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
SAR448851 		Participants will receive SAR448851 dose 1 or dose 2 oral daily for 48 weeks
  • Drug: SAR448851
    Pharmaceutical form: Capsule Route of administration: Oral
Placebo Comparator
Placebo 		Participants will receive placebo oral daily for 48 weeks
  • Drug: Placebo
    Pharmaceutical form: Capsule Route of administration: Oral

Recruiting Locations

Charter Research - Lady Lake- Site Number : 8400004
The Villages, Florida 32162

More Details

Status
Recruiting
Sponsor
Sanofi

Study Contact

Trial Transparency email recommended (Toll free for US & Canada)
800-633-1610
Contact-US@sanofi.com