The Knight Family DIAN-TU Primary Prevention Trial Announcement

May 7, 2024

The statement below is an update to the 20 December 2022 announcement by the Knight Family Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) regarding the DIAN-TU-002 Primary Prevention Trial.

In late 2022, the Knight Family DIAN-TU paused the launch of the DIAN-TU-002 Primary Prevention Trial of gantenerumab due to discontinuation of the drug development program. We are now pleased to announce plans to re-launch the DIAN-TU-002 Primary Prevention Trial with remternetug in collaboration with Eli Lilly and Company (Lilly).

Remternetug is an investigational monoclonal antibody developed by Lilly that targets and removes amyloid plaque in the brain. Other amyloid targeting therapies with similar activity have been found to slow the progression of cognitive and functional decline in individuals with symptomatic, non-autosomal dominant, Alzheimer’s disease. Remternetug can be administered subcutaneously, potentially offering a convenient treatment option to patients across the AD spectrum.

“We are extremely pleased to resume the DIAN-TU-002 Primary Prevention trial in partnership with Lilly”, said Eric McDade, DO, a professor of neurology at Washington University and the trial’s principal investigator. “Since the pause of the Primary Prevention trial, there has been clear demonstration of clinical benefit from amyloid lowering therapies at the symptomatic stage of Alzheimer’s disease. This only strengthens our need to resume the first true prevention study in Dominantly Inherited Alzheimer disease targeting amyloid pathology at the earliest possible stage.”

Unlike historical Alzheimer’s disease trials, the DIAN-TU-002 Primary Prevention Trial will treat individuals prior to onset of significant amyloid plaque build-up in the brain-up to 25 years before the expected onset of dementia. Results from recent trials and FDA approved drugs for Alzheimer’s disease have demonstrated the benefit of removing amyloid plaques from the brain. This trial will demonstrate whether remternetug can prevent amyloid plaque accumulation in participants with dominantly inherited Alzheimer’s disease (DIAD), and if prevention of amyloid build-up in DIAD can prevent or substantially slow this form of the disease.

The DIAN-TU-002 Primary Prevention Trial will utilize the current network of the Knight Family DIAN-TU sites all over the world – nearly 40 research institutes in North America, Australia, Europe, and South America to recruit individuals from families with DIAD. Trial participants will be 11 to 25 years before their expected age of dementia onset and have no or very few amyloid deposits in the brain.

Preventing or halting the earliest stages of disease could be transformative in the world of Alzheimer’s prevention. Results will further our understanding of all forms of Alzheimer’s disease, which could benefit the millions of people living with the more common late onset form of the disease. The trial is supported with funds from the National Institute on Aging (NIA), the Alzheimer’s Association, GHR Foundation, Washington University, as well as St. Louis resident, Joanne Knight, a longtime benefactor of Washington University, and her family. The trial is being conducted in close partnership with Lilly, which also is providing significant funding.

This international effort to find ways to prevent Alzheimer’s disease would not be possible without the support of many partners, as well as the active involvement of DIAD families. We thank our partners and the trial participants and their families for their ongoing commitment.