A Phase 2b/3 Clinical Study Evaluating T3D-959 in Mild-to-Moderate Alzheimer's Disease Subjects

This study is a randomized, double-blind, placebo-controlled study of T3D-959 30mg in subjects with clinical mild-to-moderate Alzheimer's Disease and a biological diagnosis of AD pathology, as defined by a validated plasma biomarker (presently %p-tau217 plasma biomarker). This study is designed as a seamless group sequential design where estimates of treatment effect on cognitive and functional scales will be evaluated in an interim analysis by independent statisticians. The sample size will be re-estimated to ensure the study is sufficiently powered to demonstrate efficacy of T3D-959 in cognition and function. Subjects will be assigned to one of two treatment arms (1:1 ratio) in a randomized, double-blind fashion, stratified by sex and ApoE4 genotype. Study medication will be taken once daily for 78 weeks. Safety/tolerability, efficacy and exploratory assessments will be evaluated for changes from baseline to end of treatment (78 weeks). Subjects will be followed for four weeks after the end of treatment.