NEW YORK – Meilleur Technologies will provide its molecular PET imaging tool, [F-18]NAV-4694, within the Consortium for Clarity in ADRD Research Through Imaging (CLARiTI) study, the company said on Monday.
The National Institute of Aging's Alzheimer's Disease Research Centers will recruit 2,000 participants into the CLARiTI study with the goal of using imaging and blood-based biomarkers to investigate the multiple causes of cognitive impairment seen in Alzheimer's disease and related disorders, or ADRDs. Researchers will use Meilleur's NAV-4694 to study amyloid deposits in the brains of individuals with ADRDs.
"A major gap in our field is the ability to detect and develop a temporal profile of the several pathologies that may be present in our older patients with cognitive symptoms. This requires a broad panel of biomarkers," Sterling Johnson, professor of geriatrics and dementia at the University of Wisconsin, Madison, and the lead researcher in CLARiTI, said in a statement. "The partnership with Meilleur will enable accessible state-of-the-art amyloid PET imaging, which we believe is foundational to further discovery."
Amyloid plaques are a hallmark sign of Alzheimer's that many believe is its root cause. The US Food and Drug Administration granted accelerated approval to Eisai and Biogen's Aduhelm (aducanumab) and Leqembi (lecanemab) based on their ability to reduce beta-amyloid proteins in patients as a surrogate endpoint. Leqembi has since gained the agency's full approval.
The emergence of these anti-amyloid drugs and other investigational agents has spurred efforts to improve diagnostics that can detect amyloid pathology in patients and better understand its role in ADRDs.
Last month, Knoxville, Tennessee-based Meilleur said NAV-4694 would be used in the Alzheimer's Disease Neuroimaging Initiative 4 clinical trial. In that study, sponsored by the Northern California Institute of Research and Education, the NIA, and the Alzheimer's Therapeutic Research Institute, researchers hope to enroll 1,100 individuals in the US and Canada who are cognitively normal or who have mild cognitive impairment or dementia and validate biomarkers associated with Alzheimer's disease.