Alzheimer’s Tau Platform (ATP) Clinical Trial

Tau protein is an important target in Alzheimer’s disease (AD), and there is now strong evidence that tau in brain is closely linked to worsening of cognition and other symptoms. 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. There has also been important progress made in the usefulness of AD biomarkers that accurate measure tau in brain, which gives researchers the tools they need to measure how drugs are working in real time. 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 therapy, to determine safety, tolerability, and biological based proof of concept based on the tau PET tracer 18F MK6240 and other tau biomarkers. 

Platform trials allow for much to be learned in the most efficient manner. A single protocol will be used, with a shared placebo group, with means more participants can be randomized to treatment groups. There are also significant savings in time and cost of the study. This trial will evaluate two tau therapies in combination with anti-amyloid therapy for 24 months in around 900 participants. 

If successful, the ATP will provide data for decision-making about which tau therapies or combinations to pursue in larger efficacy studies, an ongoing resource to test new therapeutic approaches beyond tau, and will improve understanding of AD biology.

ACTC Solution

ATP has been developed by the researchers with the most expertise on tau and leverages the experience of ACTC in trial design and conduct. Public-private partnerships are currently being developed with the companies that will provide investigational product and study support.