A Phase 2b/3 Clinical Study Evaluating T3D-959 in Mild-to-Moderate Alzheimer's Disease Subjects
brief summary
This study is a Phase 2b/3 clinical trial of a new candidate drug (T3D-959) to treat patients with mild-to-moderate Alzheimer's. The aims of the trial are to affirm potential therapeutic efficacy and safety observed in earlier clinical trials and assess the potential to modify the course of disease. The drug will be compared to placebo and administered orally to patients once a day for 78 weeks.
detailed description
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.
official title
A Phase 2b/3 Randomized, Double-Blind, Placebo-Controlled Multi-Center Study to Evaluate the Safety and Efficacy of T3D-959 in Subjects With Mild-to-Moderate Alzheimer's Disease