- Between 18-80 years of age.
- Are known to carry a mutation that causes Alzheimer’s disease (or are willing to learn genetic status before enrollment).
- Are within -10 to +10 years of the predicted age of onset (based on parent’s actual age at onset) or are already experiencing AD symptoms.
- Cognitively normal or with mild cognitive impairment or mild dementia, Clinical Dementia Rating (CDR) of 0-1 (inclusive).
- Fluency in DIAN-TU trial approved language
- Able to undergo Magnetic Resonance Imaging (MRI), Lumbar Puncture (LP), Positron Emission Tomography (PET), and complete all study related testing and evaluations.
- For women of childbearing potential, if partner is not sterilized, participant must agree to use effective contraceptive measures (hormonal contraception, intra-uterine device, sexual abstinence, barrier method with spermicide).
- Adequate visual and auditory abilities to perform all aspects of the cognitive and functional assessments.
- Has a Study Partner who, in the investigator’s judgment, is able to provide accurate information as to the subject’s cognitive and functional abilities, and who agrees to provide information at the study visits that require informant input for scale completion.
Secondary Prevention Trial (NexGen)
What is a secondary prevention trial?
These trials enroll target 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 (Tau NexGen)
DIAN-TU-001: A Phase II/III Multicenter Randomized, Double-Blind, Placebo-Controlled Platform Trial of Potential Disease Modifying Therapies Utilizing Biomarker, Cognitive, and Clinical Endpoints in 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 initial study drug arms tested in the trial were focused on amyloid-based therapies. The DIAN-TU is now planning to launch the Tau Next Generation (Tau NexGen) trial which will test three different experimental drugs focused on therapies that target tau tangles.
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. Both study drugs are investigational and have been developed by Eisai Co., Ltd. This will be the first Alzheimer’s prevention trial to target both tau tangles and amyloid plaques with two drugs at the same time. The research team continues to evaluate additional study drugs to select with expectations to add them in 2022 and/or 2023, and plans to choose from two classes of investigational tau drugs that act in different ways.
The trial’s goal is to determine the safety, tolerability, and effectiveness of each study drug. The DIAN-TU secondary prevention trial will determine if these investigational 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.
How to enroll
To be considered for this trial