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Update on the DIAN-TU-001 Trial with E2814 and Lecanemab (Eisai Co., Ltd)
The statement below is in response to Eisai’s 06 January 2023 announcement regarding the FDA’s accelerated approval of lecanemab for the treatment of symptomatic Alzheimer’s disease (AD).
On January 6th, 2023, the FDA announced approval of lecanemab (an anti-amyloid beta (Aβ) protofibril antibody) through its Accelerated Approval Program for the treatment of mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD (collectively known as early AD) with confirmed presence of amyloid pathology in the brain.
DIAN-TU recognizes the importance of this approval for patients with Alzheimer’s disease symptoms. Eisai and the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) at Washington University in St. Louis, Missouri have previously announced a collaboration to include lecanemab in the DIAN-TU Tau NexGen trial to be tested with E2814 – an experimental immunotherapy targeting the microtubule binding domain of the tau protein.
“This approval is a very important step forward in the treatment of Alzheimer’s disease. Our partnership with Eisai to include lecanemab in our combination trial will continue to move the field forward,” said principal investigator Randall J. Bateman, MD, the Charles F. and Joanne Knight Distinguished Professor of Neurology and the director of DIAN-TU.
The DIAN-TU NexGen trial of E2814 and lecanemab is currently recruiting participants [Clinicaltrials.gov NCT05269394].
FDA APPROVES LEQEMBI™ (LECANEMAB-IRMB) UNDER THE ACCELERATED APPROVAL PATHWAY FOR THE TREATMENT OF ALZHEIMER’S DISEASE
Update on the DIAN-TU-002 Primary Prevention Trial
20 December 2022
Update on the DIAN-TU-002 Primary Prevention Trial
The statement below is an update to the 15 November 2022 announcement by the Knight Family Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) regarding the DIAN-TU-002 Primary Prevention Trial with Gantenerumab.
During the presentation of topline results from GRADUATE I and II studies at the Clinical Trials in Alzheimer’s Disease (CTAD) conference in San Francisco, Roche announced its decision to discontinue the company’s clinical trials of gantenerumab, including the GRADUATION, OpenRoAD, PostGraduate and SKYLINE trials. After further consideration and consultation, the DIAN-TU has decided to pause the DIAN-TU-002 Primary Prevention Trial launch activities related to gantenerumab while continuing to evaluate the risk and benefits of gantenerumab in the DIAN-TU-001 trial [Clinicaltrials.gov #NCT01760005]. “Based on the effect of gantenerumab on amyloid biomarkers in the previous DIAN-TU-001 study and the recent GRADUATE studies, and because we are testing higher doses than those tested in the GRADUATE studies, we still believe there is good reason to evaluate gantenerumab in the Primary Prevention Trial,” said Dr. Eric McDade, Co-Director of the DIAN-TU and Principal Investigator of the DIAN-TU-002 Primary Prevention Trial. “However, we have a responsibility to our participants and stakeholders to ensure the treatment is available to enable completion of the Primary Prevention Trial. This is no longer possible with gantenerumab.”
To prepare for the inclusion of another study drug in the DIAN-TU-002 platform, the DIAN-TU is resuming enrollment of Primary Prevention participants in the cognitive run-in period. This run-in period is intended to improve the study’s statistical power, continue engagement of participants, and decrease total duration of the trial once a drug arm opens for enrollment.
“The Alzheimer’s Association fully supports making decisions about the 002 primary prevention trial based on the latest science, while always keeping the study participants’ needs at the center of all study-related actions,” said Maria C. Carrillo, PhD, Alzheimer’s Association chief science officer. “We trust the DIAN-TU study leaders to make the right decision and then move forward with this important clinical trial.”
The DIAN-TU trial platform was designed to quickly adapt to new information about investigational drugs so drug arms could be terminated or added as needed. With current funding from the NIA/NIH (U01AG059798, PI EM McDade) and the Alzheimer’s Association, the DIAN-TU will continue site and vendor readiness activities while evaluating multiple drug programs for potential use in the DIAN-TU-002 Primary Prevention Trial.
The DIAN-TU is informing study participants and applicable health authorities, study ethics committees, and institutional review boards about the decision on the DIAN-TU-002 trial. Dosing in the DIAN-TU-001 Open Label Extension will continue [Clinicaltrials.gov #NCT01760005] as designed.