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RecruitingPhase 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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
55 Years to 85 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 111 weeks, 63 weeks, 96 weeks, 48 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how safe SAR448851 is and how well it works compared with a placebo, a pill with no active drug. It is for adults ages 55 to 85 with early Alzheimer's disease and signs of amyloid protein buildup in the brain. The study drug is taken by mouth once a day.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 55 to 85 years old when you sign the consent form.
  • You have mild memory or thinking problems due to Alzheimer's disease, or mild Alzheimer's dementia.
  • Your Clinical Dementia Rating score is 0.5 to 1.0, and your memory score on that test is at least 0.5.
  • You have a study partner older than 18 who has known you for at least 1 year and spends at least 8 hours a week with you. They must sign their own consent form.
  • A PET scan, a type of brain scan, shows amyloid protein buildup in your brain.

Who can't join

  • You have a history of a serious brain or nerve disease, such as other types of dementia, Huntington's disease, Parkinson's disease, a serious brain infection, multiple concussions, multiple sclerosis, or epilepsy or repeated seizures. Childhood seizures caused by fever do not count.
  • You have more than 4 small brain bleeds, each less than 10 millimeters wide, or iron deposits on the brain's surface from bleeding.
  • You have two copies of the APOE4 gene variant.
  • You take or have taken an immune treatment that targets amyloid, such as aducanumab, lecanemab, or donanemab, or a treatment that targets a protein called TREM-2.
  • You currently take anticoagulants, medicines that help prevent blood clots.
  • You had cancer in the past 3 years. Exceptions include basal cell or squamous cell skin cancer, melanoma that has not spread beyond its starting layer, stage 1 or 2 prostate cancer, kidney cancer fully removed by surgery, or successfully treated cervical cancer that has not spread beyond its starting layer.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (8)

CA

FL

MA

NJ

  • The Cognitive and Research Center of New Jersey - Springfield- Site Number : 8400005 · Springfield, NJ 07081More trials in Springfield

OR

  • Summit Research Network - Portland - Northwest Vaughn Street- Site Number : 8400002 · Portland, OR 97210More trials in Portland

PA

TX