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.
Meet a man affected by Dominantly Inherited Alzheimer’s Disease and learn why he participates in the DIAN clinical trial.
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.
Primary Prevention Trial: Coming Soon!
The evidence is clear that amyloid beta (Aβ) accumulates in the brain years before dementia symptoms first appear.
These trials seek to intervene before amyloid plaques form in the brain.
Learn about the Primary Prevention Trial »
Secondary Prevention Trial: DIAN-TU-001
Prevention efforts target amyloid beta (Aβ) in individuals after amyloid plaques are present in the brain.
These trials seek to intervene in the disease process before too much permanent damage is done.
Learn about the NexGen (Secondary Prevention Trial) »
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 allows 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, leading the DIAN-TU to launch an exploratory open-label extension (OLE) period for gantenerumab. The Trials Unit continues to launch exciting new opportunities for DIAD families. A primary prevention trial is slotted to launch in 2021 (DIAN-TU-002). Additionally, the DIAN-TU-001 trial will start several new drug arms over the next two years.
For Investigators
Visit Investigator Resources for instructions for how to get involved, instructions for accessing resources and participation policies.