Secondary Prevention: DIAN-TU-001

Prevention efforts target amyloid beta (Aβ) in individuals after amyloid plaques are present in the brain.

DIAN-TU-001 Trial (Tau NexGen)

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.

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. In 2021, the DIAN-TU launched 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. Both study drugs have been developed by Eisai Co., Ltd. and are investigational with lecanemab receiving marketing approval in several regions. This is 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 for the trial with expectations to add them in 2025 and/or 2026, 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 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.

Click for Enrollment Criteria

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 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 participant’s cognitive and functional abilities, and who agrees to provide information at the study visits that requires input from the study partner.