THE ALZHEIMER'S DISEASE TAU PLATFORM CLINICAL TRIAL - PROJECT SUMMARY / ABSTRACT TAU PROTEIN IS AN ATTRACTIVE AD THERAPEUTIC TARGET BECAUSE THE AMOUNT AND ANATOMICAL DISTRIBUTION OF INSOLUBLE TAU AT AUTOPSY IS STRONGLY CORRELATED WITH THE SYMPTOMS AND SEVERITY OF DISEASE DURING LIFE. MULTIPLE TAU THERAPIES ARE NOW IN CLINICAL TRIALS FOR AD, WITH MANY NEW AGENTS ENTERING THE CLINIC. NEW APPROACHES TO ACCELERATING THEIR CLINICAL DEVELOPMENT ARE URGENTLY NEEDED. A VARIETY OF AD BIOMARKERS NOW EXIST, INCLUDING CSF AND PLASMA BETA AMYLOID RATIOS AND PHOSPHORYLATED TAU (P-TAU) LEVELS, AND AMYLOID AND TAU PET TRACERS, PROVIDING TOOLS TO MEASURE PHARMACODYNAMIC EFFECTS OF AMYLOID AND TAU THERAPIES ON THE CORE BIOLOGY OF AD. THE GOAL OF THE ALZHEIMER’S TAU PLATFORM (ATP) TRIAL IS TO CONDUCT A RANDOMIZED, PLACEBO CONTROLLED, PHASE 2 PLATFORM TRIAL IN PRECLINICAL-PRODROMAL AD THAT WILL SIMULTANEOUSLY TEST AT LEAST TWO DIFFERENT TAU-DIRECTED THERAPIES, ALONE OR IN COMBINATION WITH AN ANTI-AMYLOID

Summary

THE ALZHEIMER'S DISEASE TAU PLATFORM CLINICAL TRIAL - PROJECT SUMMARY / ABSTRACT TAU PROTEIN IS AN ATTRACTIVE AD THERAPEUTIC TARGET BECAUSE THE AMOUNT AND ANATOMICAL DISTRIBUTION OF INSOLUBLE TAU AT AUTOPSY IS STRONGLY CORRELATED WITH THE SYMPTOMS AND SEVERITY OF DISEASE DURING LIFE. MULTIPLE TAU THERAPIES ARE NOW IN CLINICAL TRIALS FOR AD, WITH MANY NEW AGENTS ENTERING THE CLINIC. NEW APPROACHES TO ACCELERATING THEIR CLINICAL DEVELOPMENT ARE URGENTLY NEEDED. A VARIETY OF AD BIOMARKERS NOW EXIST, INCLUDING CSF AND PLASMA BETA AMYLOID RATIOS AND PHOSPHORYLATED TAU (P-TAU) LEVELS, AND AMYLOID AND TAU PET TRACERS, PROVIDING TOOLS TO MEASURE PHARMACODYNAMIC EFFECTS OF AMYLOID AND TAU THERAPIES ON THE CORE BIOLOGY OF AD. THE GOAL OF THE ALZHEIMER’S TAU PLATFORM (ATP) TRIAL IS TO CONDUCT A RANDOMIZED, PLACEBO CONTROLLED, PHASE 2 PLATFORM TRIAL IN PRECLINICAL-PRODROMAL AD THAT WILL SIMULTANEOUSLY TEST AT LEAST TWO DIFFERENT TAU-DIRECTED THERAPIES, ALONE OR IN COMBINATION WITH AN ANTI-AMYLOID