A US university has launched a prevention trial examining the use of Eli Lilly’s investigational remternetug in young adults to prevent further development of Alzheimer’s disease.
Washington University School of Medicine has announced the first participants enrolled as part of its Alzheimer’s disease DIAN-TU-002 primary prevention trial (NCT06647498).
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The trial aims to enrol 240 participants from families with mutations in one of the three key genes and a family history of Alzheimer’s that puts them at risk of developing it at some point in their 30s. Some participants will be as young as 18.
The goal of the study is to determine if the investigational monoclonal antibody remternetug can remove plaques of a key amyloid beta (Aß) plaques from the brain or even keep them from building up in the first place during early asymptomatic stages of the condition.
This is the second in a set of three studies taking place as part of the platform Knight Family DIAN-TU trial (NCT05552157). These trials are set on examining the prevention or treatment for those at high genetic risk of developing the disease that the National Institutes of Health (NIH) says cost the US economy as much as $305bn in 2020.
The platform trial is set to be run alongside the NIH-funded research group, the Dominantly Inherited Alzheimer Network (DIAN), a group that tracks families with mutations in any of three genes that cause Alzheimer’s at a young age.
The university describes the master protocol as a Phase II/III multi-centre randomised, double-blind, placebo-controlled trial testing if it is possible to prevent Aß deposition in mutation carriers and if that can avert a cascade of pathology associated with Alzheimer’s disease.
Eric McDade, professor of neurology at the university and principal investigator for the DIAN-TU-002 trial, said: “We have seen tremendous progress in the treatment of Alzheimer’s disease in the past few years.
“Two amyloid-targeting drugs were shown to slow symptoms of the disease and have now been approved by the US Food and Drug Administration (FDA) as treatments for people with mild cognitive impairment or mild dementia due to Alzheimer’s disease.
“This provides strong support for our hypothesis that intervening when Aß plaques are at the very earliest stage, long before symptoms arise, could prevent symptoms from emerging in the first place.”
There are two other trials being carried out under the DIAN-TU platform trial. The first, DIAN-TU 001 (NCT01760005) is a Phase II/III double-blind trial examining the safety and efficacy of Eisai’s candidate E2814, alongside Leqembi (lecanemab). The study previously investigated Roche’s gantenerumab, however, Roche would later choose to discontinue its production of gantenerumab after data from other Alzheimer’s trials was not supportive.
DIAN-TU 003 (NCT06384573) is a Phase IIIb/IV open-label study also examining Leqembi in patients who were previously dosed with Roche’s gantenerumab in the DIAN-001 trial before the drug’s discontinuation.
When these trials were first announced in 2021, investigators had also chosen to use gantenerumab in the DIAN-TU 002 trial.
Mark Mintun, group vice president of neuroscience R&D at Eli Lilly, commented: “We are pleased to partner with the DIAN-TU team to evaluate whether remternetug can help slow or prevent the accumulation of amyloid plaque, a defining event in the early cascade of Alzheimer’s disease onset.”
Eli Lilly has already had a big impact on the Alzheimer’s disease market with Kisunla (donanemab), which was approved by the FDA on 2 July 2024, with UK approval by the Medicines and Healthcare products Authority (MHRA) in October. The drug, however, has not been approved for use by the National Health Service (NHS).
Lilly’s biggest competitor in the space is Biogen and Eisai’s Leqembi, which holds a first-to-market advantage after receiving approval from the FDA in July 2023. Biogen and Eisai had another therapy, Aduhelm (aducanumab) on the market but Biogen pulled the drug in January 2024, stating the company wanted “to reprioritise its resources in Alzheimer’s disease”.
This advantage is set to continue benefitting Biogen and Eisai for future years, with GlobalData predicting the drug will hit $5.33bn in global sales in 2030 while Lilly’s Kisunla is expected to make sales of $1.79bn in the same year.
GlobalData is the parent company of Clinical Trials Arena.
