Washington University Leads Groundbreaking Alzheimer’s Prevention Trial

The Washington University School of Medicine in St. Louis has unveiled a new clinical trial named the Primary Prevention Trial. This initiative aims to prevent Alzheimer’s disease in young adults who are at a high risk, using a promising new investigational drug from Eli Lilly and Company.

nabbed the First Participants

The study has launched its recruitment phase, enrolling the initial participants in an ambitious clinical trial. This effort seeks to determine whether halting early molecular changes associated with Alzheimer’s can prevent the disease altogether.

Exploring Halting Alzheimer’s Early Onset

Known as the Primary Prevention Trial, the study evaluates remternetug, an investigational antibody produced by Eli Lilly and Company. This drug targets amyloid beta plaques, which researchers consider a crucial early phase of the disease’s development.

Genetic and sporadic forms of Alzheimer’s begin with amyloid accumulation often decades before cognitive symptoms appear. By targeting these early plaques either by removal or prevention, scientists hope to derail the disease process at its earliest stage, potentially stopping symptoms in their tracks entirely.

Potential for a Breakthrough Alzheimer’s Treatment

Eric McDade, DO, a neurology professor and the trial’s principal investigator, expressed optimism. “Recent advancements in treating Alzheimer’s have provided support for early intervention. Two FDA-approved drugs that slow Alzheimer-related symptoms when the disease is already present advocate for halting the disease process at its earliest stage before symptoms arise.”

Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) and DIAN

Part of the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), a global effort that receives funding from the National Institutes of Health, the trial includes participants from families with genetic mutations linked to early-onset Alzheimer’s.

Children from such families have a 50% chance of inheriting these mutations and generally develop symptoms near the same age as their parents. Therefore, all participants in this trial come from such high-risk backgrounds.

Hannah Richardson: A Personal Drive for Research

Hannah Richardson, 24, a participant in the Primary Prevention Trial, shared her motivations. “Both my grandfather and his mother fell victim to Alzheimer’s, along with his brothers. My mom was always an advocate for Alzheimer’s research, and I have always aspired to follow in her footsteps.”

Richardson has been participating in DIAN trials since she was ten years old. Her dedication to the cause is unwavering as she hopes to contribute to understanding and potentially curing Alzheimer’s disease.

A Drug Shift

The initial plan for the trial involved a different investigational drug, gantenerumab, by Roche/Genentech. However, when data from other Alzheimer’s trials did not support gantenerumab’s effectiveness, researchers pivoted to remternetug.

In early phase trials for more common forms of Alzheimer’s, remternetug showed impressive results, eliminating amyloid plaques as effectively as donanemab, an FDA-approved Alzheimer’s therapy by Lilly. Additionally, this investigational treatment can be administered via subcutaneous injection, offering a quicker and less invasive alternative to the FDA-approved treatments’ IV infusion method.

Participants will receive remternetug or a placebo every three months, a less frequent dosing schedule than the FDA-approved medications.

Study Design and Objectives

The Primary Prevention Trial will recruit the first 240 participants from families carrying mutations in the three key genes linked to early-onset Alzheimer’s. Eligible candidates include both carriers and non-carriers of the mutation, with non-carriers serving as a comparative group.

Participants must be between 11 to 25 years younger than their predicted symptom onset based on their family history, with no sign of cognitive impairment and minimal amyloid deposits in their brains. At the end of the two-year experimental period, eligible mutation carriers will receive remternetug for an additional four years as part of an open-label extension.

Research focuses on remternetug’s ability to prevent the buildup of amyloid plaques in the brain and its effects on blood and cerebrospinal fluid markers of Alzheimer’s. Due to the participants’ young age, cognitive changes during the trial are not anticipated. Long-term monitoring will be conducted to assess cognitive effects.

Funding and Collaborations

The project has received over $130 million in funding, with the National Institute on Aging providing an estimated $98.3 million and the Alzheimer’s Association and GHR Foundation contributing $14 million. Additional funds come from Washington University’s efforts and generous donors like Joanne Knight, totaling $11.5 million.

“The Alzheimer’s Association is honored to be a part of this collaboration between academia, government, industry, philanthropy, and DIAN families,” stated Maria C. Carrillo, PhD, Alzheimer’s Association chief science officer. “The study has the potential to revolutionize Alzheimer’s prevention strategies.”

A Promising Next Step

Mark Mintun, MD, Group Vice President-Neuroscience R&D at Lilly, commented, “We are thrilled to join the DIAN-TU team in evaluating whether remternetug can prevent the accumulation of amyloid plaque, a hallmark of early Alzheimer’s disease onset.”

This initiative holds significant promise for individuals and families impacted by Alzheimer’s, as well as the broader population. With an estimated 13 million Americans projected to develop Alzheimer’s by 2050, the potential impact of this study cannot be overstated.

The potential for transforming Alzheimer’s treatment through prevention rather than symptom management makes this clinical trial an essential step toward combatting the disease.

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