ClinicaliQ Trial Snapshot
- A Study to Investigate the Safety and Effectiveness of SAR448851 in Participants With Early Alzheimer’s Disease — Recruiting • Phase II • Respiratory / COPD / Asthma • NCT07688213.
- What is being tested: SAR448851, a novel once-daily oral medication, is being evaluated in a randomized, placebo-controlled Phase 2 trial to assess its efficacy and safety in slowing cognitive decline in early Alzheimer's disease patients.
- Patient eligibility overview: The study targets early-stage Alzheimer's disease patients, typically those with mild cognitive impairment or mild dementia stages, who can tolerate daily oral medication and meet specific diagnostic criteria for AD pathology.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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…
Eligibility Snapshot
- : * 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.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.