PET scans augmented by injections of the beta-amyloid targeting tracer florbetaben F18 are effective at helping confirm or rule out Alzheimer’s disease in patients under evaluation for cognitive impairment.

The study behind the conclusion is running in the current edition of Alzheimer’s & Dementia.

Led by Osama Sabri, MD, PhD, of the University of Leipzig in Germany, study authors designed the non-randomized, multicenter, phase-3 trial to demonstrate the accuracy of the radiopharmaceutical by comparing in vivo PET imaging with post-mortem histopathology.

With an eye on estimating the density of neuritic beta-amyloid plaques—a reliable indicator of Alzheimer’s—the investigators looked at brain images and tissue from 74 deceased subjects from among 205 who had undergone florbetaben PET and agreed to donate their brains to science.

The researchers found that high sensitivity and specificity for florbetaben PET were confirmed by histopathology in “clinically relevant whole-brain visual analyses, allowing the reliable detection and exclusion of amyloid pathology,” according to the study conclusion.

Taken together with results from earlier studies, these latest data “support the value of florbetaben PET as a diagnostic marker and a valuable adjunct for the exclusion of Alzheimer’s disease or a differential diagnosis of dementia,” Sabri stated in prepared remarks.  

The florbetaben used in the trial is marketed as Neuraceq by Piramal Imaging, which co-funded the study. The radiopharmaceutical was approved for clinical use in the U.S., Europe and South Korea in 2014.

According to the World Health Organization, approximately 7.7 million new cases of dementia are diagnosed each year worldwide, with Alzheimer’s diagnoses accounting for 60 to 80 percent. At the same time, an estimated 20 to 30 percent of clinical diagnoses of probable Alzheimer’s “are found to be incorrect upon post-mortem histological investigation,” according to Piramal, “underscoring the need for more accurate diagnostic tools.”