The Institute on Aging hosted its 2024 Vincent J. Cristofalo Annual Lectureship on Monday, June 3. This year’s keynote speaker, Mark Mintun, MD, Vice President of Pain and Neurodegeneration Research and Clinical Development Chief Medical Officer of Avid Radiopharmaceuticals, discussed the background of Alzheimer’s disease (AD) pathology and its clinical course, the development of pathology biomarkers, and recent developments in disease modifying therapy specifically highlighting Donanemab.
He started by discussing the timeline of Alzheimer’s disease and related disorders (ADRD) and the diagnostic evolution of AD which is now defined by presence of pathology. He explained the advancement of identifying amyloid-beta plaques and tau tangles, then recognizing the genetic risk factors, the ability of doing amyloid and tau imaging, acceleration of more formal diagnostic criteria once biomarkers were discovered to better understand the underlying pathology of patients prior to autopsy, and finally now in the last few years drug approvals for treatments to remove the amyloid.
“The number of disease modifying drugs has dramatically increased in Alzheimer’s disease research,” said Dr. Mintun. He focused much of his talk on Donanemab, a drug that binds to amyloid plaque and allows the body to clear or remove them from the brain to slow clinical decline in patients with cognitive impairment, and the phases of the clinical trial for this drug.
The drug has not yet been approved by the FDA, but received an unanimous vote of support from the Central Nervous System Drugs Advisory Committee at the June 10, 2024, hearing discussing the new drug application and its results from a phase 3 trial. If approved, donanemab will be the third anti-amyloid therapy to gain FDA approval, following aducanumab (Aduhelm) in 2021 which has since been pulled from the market, and lecanemab (Leqembi) in 2023.
In summary, Dr. Mintun stressed the importance of keeping an eye on biomarkers in ADRD research. “The science supporting blood-based biomarkers is rapidly evolving,” he said. “Existing biomarkers can be used to significantly enrich populations for AD pathology prior to more extensive evaluation, such as PET.”
To learn more about Dr. Mintun’s work and Avid Radiopharmaceuticals, a wholly-owned subsidiary of Eli Lilly and Company, click here.
To view photos from the event, click here.