# DIAN-TU Primary Prevention Trial NfL Characterization Admin Supp

> **NIH NIH U01** · WASHINGTON UNIVERSITY · 2022 · $293,537

## Abstract

(No change from Parent Grant) PROJECT SUMMARY
 The DIAN-TU platform was formed to design and manage interventional therapeutic trials and find a
treatment that provides cognitive benefit for those certain to develop dominantly inherited AD (DIAD). The
DIAN-TU trial platform is now fully operational in 6 countries and 24 sites with another 13 countries and 26
sites in start-up. The current DIAN-TU-001 trial will accommodate 11 languages and has three different
therapies being tested in secondary prevention (i.e. cognitively normal participants with substantial AD
pathology). NIA funding for the DIAN-TU trial platform established the infrastructure and operations for
executing clinical trials in DIAD and acknowledged the need for evolution within this platform.
 The DIAN-TU Primary Prevention Trial is a first of its kind, phase II/III, 4-year randomized, blinded
placebo-controlled (1:1) trial in 160 asymptomatic dominantly inherited Alzheimer disease mutation carriers
who are more than 15 years before the estimated year of symptom onset (EYO) and have minimal to no Aß-
PiB plaque burden at trial entry. Current trials in asymptomatic individuals target Aß after pathology is
established; these secondary prevention efforts are likely more effective than treating at later more
advanced stages, however the most effective approach is to prevent AD pathology from forming. The goal of
this proposal is to implement a placebo controlled biomarker endpoint clinical trial targeting amyloid
deposition in subjects at risk for DIAD, prior to onset of significant Aß pathology.
 In this study, we will test if it is possible to prevent Aß deposition in DIAD mutation carriers and if doing so
will prevent the cascade of pathology associated with AD and, ultimately, dementia in a population that is
otherwise certain to get the disease. Regardless of the outcome of this study, it will be highly impactful on the
AD field in assessing the ability to prevent amyloidosis and the consequences of doing so at the earliest
stages of the AD pathological cascade. If the prevention of Aß pathology in DIAD is accomplished, it will lay
the foundation for the ultimate test of the amyloid hypothesis and provide the best opportunity to prove that
dementia in this highly vulnerable population, and possibly in sporadic AD and Down syndrome, can be
dramatically modified. Should preventing amyloid pathology from developing have no impact on the course of
the disease, particularly in this population, this would direct future research and therapeutics towards other
mechanisms and pathologies.

## Key facts

- **NIH application ID:** 10619079
- **Project number:** 3U01AG059798-03S1
- **Recipient organization:** WASHINGTON UNIVERSITY
- **Principal Investigator:** Eric Martin McDade
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $293,537
- **Award type:** 3
- **Project period:** 2018-09-15 → 2025-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10619079

## Citation

> US National Institutes of Health, RePORTER application 10619079, DIAN-TU Primary Prevention Trial NfL Characterization Admin Supp (3U01AG059798-03S1). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10619079. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*