Advocate Memory Center in Park Ridge is the first site in Illinois to offer participation in a leading-edge clinical trial for people at risk for a form of Alzheimer’s disease that strikes much earlier in life, called Dominantly Inherited Alzheimer’s disease, or DIAD.
DIAD refers to a mutation on one of 3 genes (presenilin 1, presenilin 2 or amyloid precursor protein), which causes early onset Alzheimer’s. The mutation runs in some families and is passed down to future generations. People with a family history of DIAD have a 50% chance of inheriting the gene mutation, and those who carry it typically develop Alzheimer’s sometime between the ages of 30 and 60 years.
The DIAN-TU-001 clinical trial is currently evaluating the safety and effectiveness of two investigational Alzheimer’s treatments, lecanemab and E2814, when given separately and in combination to people who have a DIAD mutation.
Lecanemab, which recently received accelerated approval by the U.S. Food and Drug Administration, is designed to reduce the amount of beta-amyloid plaque, a protein deposit that accumulates early in the course of Alzheimer’s disease. E2814 is an investigational drug designed to reduce the amount of tau, a protein linked to brain damage when it malfunctions. Tau binds together to form tangles, which grow and spread across the brain as Alzheimer’s worsens.
“Because there’s certainty surrounding who will develop the disease and at what age, we can begin to evaluate lecanemab and E2814 before Alzheimer’s develops and during its earliest stages when cognitive decline is still minimal,” said behavioral neurologist Darren Gitelman, MD, senior medical director of Advocate Memory Center and Advocate Aurora Research Institute’s principal investigator for the study. “The potential for future Alzheimer’s disease prevention may be possible if a treatment is found that can delay symptom onset, as it’s been shown that pathologic deposits leading to Alzheimer’s disease can start around 15 years before symptoms start, or around 25 years before the onset of dementia.”
Research participants who meet eligibility criteria may enroll in the DIAN-TU-001 study during a 20-year time span, any time between 10 years prior to and 10 years after the expected age of onset for their family’s type of inherited mutation.
Participants will receive treatments for a four-year period, and researchers will closely monitor and gather test result data on safety measures, Alzheimer’s biomarker levels, cognitive functions and brain imaging.
“Findings from this study will help to determine if the study treatments may delay the onset or progression of Alzheimer’s in people with a DIAD mutation,” said Nina Garlie, PhD, vice president of clinical trials research for the Research Institute. “Trials like this are critical to discovering effective Alzheimer’s treatment and prevention, both for those with a family history of DIAD and the millions of Americans currently living with the disease.”
The DIAN-TU-001 clinical trial, also known as, “A phase 2/3 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,” is sponsored by the Dominantly Inherited Alzheimer Network Trials Unit of Washington University in St. Louis.
To learn more about Advocate Aurora’s research, visit aah.org/research.