Secondary Prevention Trial (NexGen)
What is a secondary prevention trial?
A secondary prevention trial targets Aβ after pathology is established in asymptomatic individuals. While changes in the brain have begun at this point, “secondary prevention” efforts seek to intervene in the disease process before too much permanent damage is done.
About the Secondary Prevention Trial (NexGen)
DIAN-TU-001: A Phase II/III Randomized, Double-Blind, Placebo-Controlled, Cognitive Endpoint, Multicenter Study of Potential Disease Modifying Therapies in Individuals at Risk for and with Dominantly Inherited Alzheimer’s Disease
Principal Investigator: Randall J. Bateman, MD, the Charles F. and Joanne Knight Distinguished Professor of Neurology at Washington University School of Medicine in St. Louis.
In 2012, the Dominantly Inherited Alzheimer Network Trials Unit (DIAN‐TU) at Washington University in St. Louis launched the first secondary prevention trial for Dominantly Inherited Alzheimer’s Disease (DIAD) families. The Trials Unit continues to launch exciting new opportunities for DIAD families.
In August 2018, the DIAN‐TU announced the plan to launch a US NIH-funded Cognitive Run‐In (CRI) period for participants to enroll when no study drug is available for immediate enrollment. This means that those individuals that are at risk or known carriers of a DIAD mutation have an opportunity for enrollment and contribution in advance of the next drug arm starting. Participation in CRI may help better identify the eﬀectiveness of study drug arms once new drugs are added to the trial, and may help with learning results of the trial faster by decreasing the time it takes to enroll participants once a drug arm is open.
The trial’s goal is to determine the safety, tolerability, and effectiveness of each drug. The DIAN-TU secondary prevention trial will determine if these medications can prevent, delay, or possibly even reverse Alzheimer’s disease changes in the brain.
This study focuses on individuals who have a genetic likelihood to develop DIAD at a young age, typically in their 30s, 40s, or 50s. Although there are differences between DIAD and the more common age‐associated sporadic Alzheimer’s disease, the results of this study may have implications for future studies and treatments in sporadic Alzheimer’s disease. For additional information, please contact the DIAN Expanded Registry at firstname.lastname@example.org.