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 (NCT07688213)

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.

Trial phase

Phase 2

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

A/Prof David Darby

Key inclusion data

INCLUSION: Age 55 to 85 years at time of consent; Mild cognitive impairment or mild dementia due to Alzheimer’s disease (AD); MMSE Score ≥ 20; Have evidence of brain amyloid; Study partner available (≥8 hours/week of contact); Weight ≥45 kg; Must agree on fasting schedule (3 hours prior and 2 hours after study drug intake) and diet restrictions. EXCLUSION: APOE4/4 homozygous participants; significant neurological disease affecting the central nervous system (other than AD); history of ARIA-E or CAA-ri; taking anti-amyloid treatment or anticoagulants (antiplatelet agents are accepted).