First Subject Enrolled In The Tau NexGen Study For DIAD
A recent press release from Eisai Co., Ltd. has revealed that the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, has enrolled its first subject in Phase II/III of the Tau NexGen study’s Eisai’s Anti-mtbr (microtubule-binding region) Tau Antibody E2814 for Dominantly Inherited Alzheimer’s Disease (DIAD). The tau protein is found in brain cells, and its main purpose is to stabilize microtubules to help transport nutrients and other vital substances from one nerve cell to another.
What is the Purpose of the Study?
According to the press release, “The study will assess the effect of Eisai’s investigational anti-microtubule binding region (MTBR) tau antibody E2814, in dominantly inherited Alzheimer’s disease (DIAD).”
People who have genetic mutations of DIAD are known to develop Alzheimer’s disease (AD). They are also said to develop symptoms at around the same age their affected parents did.
The press release continues, “The purpose of the Tau NexGen study is to assess the safety, tolerability, biomarker and cognitive efficacy of investigational therapies in pre-symptomatic or symptomatic participants who have an AD-causing gene mutation.” Basically, the study will assess whether the drug slows cognitive decline and has further effects on tau pathology.
What Is E2814?
An investigational anti-microtubule binding region (MTBR) of the tau antibody, E2814, is being developed as a disease-modifying agent for tauopathies, including sporadic AD.
As stated in the press release, “Phase I clinical studies are underway. E2814 was discovered as part of the research collaboration between Eisai and University College London. E2814 is designed to prevent the spreading of tau seeds within the brains of affected individuals.”
Since amyloid plaques appear before tau tangles, this study design will determine if clearing the amyloid will allow the anti-tau drugs to work more effectively.
What Does This Mean for Those Suffering From DIAD?
All in all, this new study could have the potential to have an effect on disease pathology and to slow down the progression of the disease. More specifically, “An 80% or higher estimated probability of demonstrating 25% or greater slowing in clinical decline at 12 months treatment measured by ADCOMS, a six-scale dementia composite scale exam, from baseline compared to placebo.”