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

RecruitingPhase 2Ages 55 Years - 85 YearsAllSanofi
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 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.
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What it tests

  • SAR448851
  • Placebo
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Where

20 sites
Healthy Brain Clinic- Site Number : 8400011
Long Beach, United States
Oakland Clinical- Site Number : 8400010
Oakland, United States
Aqualane Clinical Research- Site Number : 8400001
Naples, United States
K2 Medical Research - Orlando - South Orlando Avenue- Site Number : 8400008
Orlando, United States
Charter Research - Lady Lake- Site Number : 8400004
The Villages, United States
Boston Center for Memory - Newton- Site Number : 8400007
Newton, United States
The Cognitive and Research Center of New Jersey - Springfield- Site Number : 8400005
Springfield, United States
Summit Research Network - Portland - Northwest Vaughn Street- Site Number : 8400002
Portland, United States

โ€ฆand 12 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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