NEW YORK – Meilleur Technologies on Friday said its investigational PET imaging agent [F-18]NAV-4694 will be used in the Alzheimer's Disease Neuroimaging Initiative 4 (ADNI4) clinical trial.
The Northern California Institute of Research and Education, the National Institute on Aging, and the Alzheimer's Therapeutic Research Institute are sponsoring the trial that aims to validate biomarkers associated with Alzheimer's disease. In the randomized, natural history, non-treatment study, researchers are enrolling more than 1,100 participants across nearly 60 sites in the US and Canada who are cognitively normal or who have mild cognitive impairment or dementia. Participants are undergoing a variety of tests, and researchers are collecting cognitive, imaging, biomarker, and genetic data for up to five years.
The latest research collaboration with Meilleur will allow investigators to study the PET imaging agent's ability to assess beta-amyloid plaque in study participants' brains.
Beta-amyloid is a hallmark sign of Alzheimer's that many say is the root cause of the progressive neurodegenerative disease. It's also the surrogate biomarker upon which the US Food and Drug Administration granted accelerated approval to Eisai and Biogen's Aduhelm (aducanumab) and Leqembi (lecanemab). Leqembi has since gained the agency's full approval.
Identifying testing methods for beta-amyloid and figuring out reimbursement for these diagnostics have become a growing area of focus within neurology, since a patient's physician must confirm the presence of beta-amyloid pathology before prescribing an anti-amyloid drug like Aduhelm and Leqembi.
"We are pleased to add NAV4694 to our portfolio of tracers utilized in ADNI4," Michael Weiner, principal investigator of the study and a professor of radiology at the University of California, San Francisco, said in a statement. "It is an exciting time in Alzheimer's research, and we believe tools, such as NAV4694, will help us better understand future applications of therapy and intervention."
Last week, the US Centers for Medicare & Medicaid Services took a step toward broadening Medicare coverage of beta-amyloid PET scans by in some cases covering the use of such scans even when performed outside of research studies. Now, the specific circumstances in which PET scans will be covered will be determined by local Medicare administrative contractors.