Award

National Institute on Aging 5R01AG068319-05

DIAN-TU: Tau Next Generation Prevention Trial

Recipient

Washington University

Award Amount

$16,532,036.00

Ceiling

$16,532,036.00

Awarded

June 23, 2026

Identifier

5R01AG068319-05

This award funds the DIAN-TU Next Generation Tau trials, which aim to test three anti-tau or anti-tau/anti-amyloid combination therapies in individuals with dominantly inherited Alzheimer's disease. The trials focus on biological engagement of tau and potential cognitive benefits, with the goal of accelerating development of disease-modifying therapies for Alzheimer's disease.

Description

The DIAN-TU Next Generation Tau trials will test three anti-tau or anti-tau/anti-amyloid combination therapies in the dominantly inherited Alzheimer's disease (DIAD) population using diverse mechanisms of tau targets, including a tau antibody to target soluble spreading, a genetic treatment to lower tau production, and an aggregation inhibitor. These phase 1b and 2 biomarker endpoint trials will test whether tau and/or in combination with amyloid therapies can demonstrate biological engagement of tau, engagement of downstream AD pathophysiologic processes, and potential cognitive and clinical benefit to launch phase 3 validation studies. The results of this study would provide the AD field with a greater understanding of tau or combination therapeutic targets and their long-term effectiveness and safety, accelerate identification of disease-modifying therapies in DIAD, and if the outcome is successful, potentially benefit millions of individuals affected by AD and their families.

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