ten years closer to Alzheimer’s prevention

CELEBRATING A DECADE OF ACCELERATED PROGRESS

Select a moment below, or flip between highlights from the past ten years.

2015

ATRI Founded as a San Diego Institute of USC

The Alzheimer’s Therapeutic Research Institute (ATRI) was founded by Paul S. Aisen, MD and a group of about 40 faculty and staff who had been working together for many years at the Alzheimer’s Disease Cooperative Study (ADCS), which at the time was the primary National Institutes of Health (NIH) funded program conducting clinical trials in Alzheimer’s disease (AD).

Located in San Diego and part of the University of Southern California (USC) Keck School of Medicine, the mission of ATRI is to accelerate the development of effective therapies for AD.

ACTC Funded and Established under the leadership of USC, Mayo Clinic, and Harvard

In 2016, NIA released a funding opportunity announcement inviting applications for a new academic network called the Alzheimer’s Clinical Trial Consortium (ACTC). The announcement incorporated many new ideas resulting from decades of experience in the field, including the value of a central institutional review board, standing support for trial sites and separation of project funding from the parent grant mechanism, among others. The first ACTC grant was awarded to a team of investigators at three institutions, USC, Harvard and the Mayo Clinic.

PRIME Study Results Published

The PRIME study publishes its findings on Aducanumab, demonstrating its ability to clear amyloid from the brain in Alzheimer’s patients.

Blood Biomarkers for Early Detection

Innovative blood tests for Alzheimer's biomarkers emerge, offering simpler, earlier, and more accurate diagnostic options.

The single institutional review board (sIRB) mandate goes into effect

The single IRB (sIRB) mandate, a requirement for multi-site research to be reviewed by a single institutional review board, went into effect for the National Institutes of Health (NIH) on January 25, 2018. For other federally funded research, including that funded by the Department of Health and Human Services (HHS), the sIRB mandate was implemented on January 20, 2020

A4 Study Clinical Trial Results Released

The A4 Study clinical trial results were announced in March 2023, and published in the New England Journal of Medicine in July 2023. https://www.a4studydata.org/

Enrollment for the AHEAD 3-45 Study Begins

On July 14th, 2020, the first infusion of an investigational drug that aims to delay or help to prevent the earliest memory loss due to Alzheimer’s disease took place in September at Butler Hospital in Providence, R.I., researchers announced.

Funded by the National Institutes of Health (NIH) and Eisai Inc., a US subsidiary of Eisai Co., Ltd. (Headquarters: Tokyo), the AHEAD Study is the first Alzheimer’s disease trial to recruit people as young as 55 years old who are at risk of developing symptoms of Alzheimer’s disease as they get older. It introduces a personalized medicine approach that will tailor treatment dose levels to a participant’s particular risk of memory loss related to Alzheimer’s disease.

Two new ACTC studies are funded

In 2020, two new Alzheimer's Clinical Trials Consortium (ACTC) studies were funded by the NIA:

1.CT1812 (collaboration with Cognition Therapeutics) was announced on June 8th. 

2.Life’s End Benefit of Cannabidiol and Tetrahydrocannabinol (LiBBY) was announced on September 10th.

Key initiatives kicked-off for ACTC’s aim of a well-trained workforce:

1. The Institute on Methods and Protocols for Advancement of Clinical Trials in ADRD (IMPACT-AD) course took place September 14 – 17. Even with the added challenge of meeting virtually, it was a huge success.

2. The Early-Career Project Evaluation Committee is committee which ensures input from the ACTC’s newest investigators on proposals while providing a key training opportunity and platform to develop experience evaluating study proposals.

ACTC forms its first Research Participant Advisory Board

The Alzheimer’s Clinical Trials Consortium (ACTC) formed its first Research Participant Advisory Board, with quarterly meetings throughout the year. This group has been integral in providing feedback on the approach to conducting ACTC studies.

ACTC launches the Site Metrics Reporting initiative

The Alzheimer's Clinical Trials Consortium (ACTC) launched the Site Metrics Reporting initiative, starting with the AHEAD study, which includes quarterly report cards and surveys capturing two-way feedback between the Alzheimer’s Therapeutic Research Institute which serves as the Coordinating Center and the clinical trial sites.

Aducanamab receives accelerated FDA Approval in a controversial decision

Aduhelm receives FDA approval via the accelerated pathway, becoming the first Alzheimer’s treatment targeting the disease’s underlying pathology.

Lecanemab receives the first full FDA approval for a disease-modifying (slowing) therapy

Lecanemab is approved by the FDA, representing another significant advancement in treatments that target Alzheimer’s core pathology.

ATRI Expands Scope

The Alzheimer’s Therapeutic Research Institute (ATRI) successfully recruited our long-term collaborator Robert Rissman, Director of ATRI Biomarker Laboratory and Biorepository to establish a Neuroscience Translational Research Division. This change greatly expands the scope of ATRI to include basic science translational research in models of disease that can serve as preclinical work for future therapeutics.

Donanemab's Phase 3 Success

Donanemab demonstrates effectiveness in slowing cognitive and functional decline in Alzheimer’s patients in the TRAILBLAZER-ALZ 2 trial.

Dr. Aisen Honored with Epstein Alzheimer’s Disease Director’s Chair

USC’s Alzheimer’s Therapeutic Research Institute (ATRI) in San Diego hosted the chair installation ceremony, which recognized and honored Dr. Aisen’s decades of work leading teams toward more effective treatments for Alzheimer’s disease. The Director’s Chair was endowed by the Epstein Family Foundation as another generous gift in a series of significant donations catalyzing Alzheimer’s research in Southern California.

Full FDA Approval for Lecanemab

The FDA grants full approval to Leqembi for Alzheimer’s treatment, marking it as the first traditionally FDA-approved therapy to slow disease progression and improve patient outcomes.

A4 Study Data Released

The A4 Study clinical trial results were announced in March 2023, and published in the New Journal of Medicine in July 2023

Featured News

Will Alzheimer’s disease become preventable within a decade? Researchers from USC Alzheimer’s Therapeutic Research Institute say ‘yes’

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faculty + Staff Insights

ROBERT RISSMAN, phd – biomarker laboratory and biorepository

“The past 10 years have been unprecedented for AD therapeutic development, both in terms of new treatments but also in terms of plasma biomarkers for detection. ATRI has had a major role in these new developments, and I look forward to the next 5-10 years which will be more incredible as we advance the field by identifying new targets for treatment and complete our asymptomatic and tau trials. ”

MICHAEL RAFII, MD, PHD – MEDICAL SAFETY

“This is an incredibly exciting time in Alzheimer’s research. For the first time, we have treatments that slow the disease. We are now targeting the earliest stages of the disease—before symptoms even begin. New study designs are accelerating progress and, importantly, allowing us to bring these advances to individuals with genetically defined forms of Alzheimer’s, including people with Down syndrome.”

REMA RAMAN, phd – Biostatistics, Participant Recruitment & Retention

“As ATRI marks 10 years of advancing Alzheimer’s research, we honor the ATRI team, our partners, and the participants who brought us here. We remain committed to rigorous science, training future researchers, and advancing a future where prevention, early detection, and equitable access to approved treatments are within reach for all.”

Michael Donohue, PhD — Biostatistics

“It has been an immensely rewarding honor to contribute to ATRI’s growth and accomplishments over the past 10 years. I am especially proud of our commitment to open science and data sharing, particularly through ADNI and A4/LEARN. ADNI data has likely informed the design of nearly every Alzheimer’s trial in the past decade, and A4/LEARN will help shape the next generation of prevention studies.”

GUSTAVO JIMENEZ-MAGGIORA PHD, MBA – INFORMATICS

"I am proud to be part of an exceptional team of scientists dedicated to advancing the frontiers of Alzheimer’s disease research. Through rigorous testing of novel diagnostics and therapies, we are working to transform the future of care and prevention. Since its founding over a decade ago, the Alzheimer’s Therapeutic Research Institute (ATRI) has been at the forefront of many groundbreaking innovations in the field. Our progress has been made possible through the steadfast support of USC, our sponsors and partners, and the vibrant Southern California community. Together, we are making a meaningful global impact."

Alison Belsha - Clinical Operations

“It is an honor to be part of ATRI’s decade of dedication, scientific discovery, and an unwavering commitment to advancing the field of Alzheimer’s research. Collaborating with colleagues whose pursuit of bold science and compassionate purpose is both a privilege and an inspiration.”