Fosgonimeton in mild-to-moderate Alzheimer's disease.

ABSTRACT:

Background

Fosgonimeton, a small-molecule positive modulator of the neurotrophic hepatocyte growth factor (HGF) system, was studied in participants with Alzheimer's disease (AD).

Objective

To assess the efficacy and safety of fosgonimeton in AD.

Methods

LIFT-AD was a randomized, placebo-controlled, Phase 2/3 trial (NCT04488419; 23Jun2020), the primary analysis (N = 287) included participants with mild-to-moderate AD not receiving concomitant acetylcholinesterase inhibitors (AChEIs) randomized 1:1 to daily subcutaneous fosgonimeton 40 mg or placebo. The primary endpoint, the Global Statistical Test (GST) score, combined ADAS-Cog11 and ADCS-ADL23. Secondary endpoints included ADAS-Cog11, ADCS-ADL23, and NfL. Exploratory endpoints included plasma biomarkers of AD. Safety

SUBMITTER: Porsteinsson AP 

PROVIDER: S-EPMC12701236 | biostudies-literature | 2025 Jan-Dec

REPOSITORIES: biostudies-literature