Clinical Trials

The DIAN-TU platform implements interventional therapeutic trials for at-risk families with DIAD, focusing on drugs that can potentially change the course of the disease.

DIAN-TU Trials

The DIAN-TU is planning to enroll into two types of trials: primary prevention trials and secondary prevention trials. Trial site staff will determine which study is best suited for each potential participant, based on their estimated years to (symptom) onset, or “EYO”.  A person’s EYO takes into consideration the actual age of the participant and the age at which their parent or relative became symptomatic.

History

The DIAN-TU platform introduced novel designs for Alzheimer’s disease trials, including simultaneous testing of multiple treatments in parallel from industry partners to enable trial efficiencies, such as pooled placebo groups.

In 2012, the Dominantly Inherited Alzheimer Network Trials Unit (DIAN‐TU) at Washington University in St. Louis launched the first prevention trial for Dominantly Inherited Alzheimer’s Disease (DIAD) families (DIAN-TU-001).  The trial began with two investigational drugs (gantenerumab and solanezumab) and focuses on drugs that can potentially change the course of the disease. The DIAN-TU launched a third drug arm (atabecestat) in 2017 which was halted in 2018 due to a determination that the risk/benefit balance was no longer favorable.  The DIAN-TU also launched a Cognitive Run-In (CRI) period in 2019, which allowed participants to enroll in the trial when no study drug is available for immediate enrollment. In 2020, after analyses of the trial data from the initial two drug arms, it was determined that gantenerumab had a positive impact on the biomarkers of the disease. The DIAN-TU continued treatment with gantenrumab in an open label extension study (OLE) which ended mid-2023. The DIAN-TU is now planning to launch the DIAN-TU-003 Amyloid Removal Trial (ART) with lecanemab for OLE participants. Also, in 2021, the DIAN-TU launched the Tau Next Generation (Tau NexGen) prevention trial which will test three different experimental drugs focused on therapies that target tau. The first tau study drug to be tested is known as E2814 and is designed to target tau tangles; in addition, an active anti-amyloid study drug called lecanemab (designed to target amyloid plaques) will also be administered. The Trials Unit continues to launch exciting new opportunities for DIAD families. A primary prevention trial is slotted to launch in late 2024 (DIAN-TU-002).  Additionally, the DIAN-TU-001 trial will start new drug arms over the next few years.