Florbetaben PET Imaging Diagnoses Amyloid Beta Plaques in Alzheimer's

A new scan may make it easier for doctors to accurately diagnose Alzheimer’s disease (AD). The results from the Phase III trial of florbetaben F18 injection, known by the trade name Neuraceq, were published in Alzheimer’s & Dementia: The Journal of the Alzheimer’s Association. The injection material is a radiopharmaceutical that is used in imaging to “estimate the density of neuritic beta-amyloid plaques in the brains of adult patients with cognitive impairment.” The study was completed at the Lou Ruvo Center for Brain Health at the Cleveland Clinic in Ohio. The lead researcher was Sabri Osama, MD, PhD, of the University of Leipzig, Germany.

The Phase III trial was open-label, non-randomized, and multicenter. There were a total of 216 trial participants who received the injection, and of whom 205 agreed to donate their brains after death. The investigators analyzed tissue and images from 74 of those deceased participants. “A high correlation between florbetaben accumulation and presence of beta-amyloid plaques was found,” according to researchers.

This new treatment is a negative indicator, that is, “a scan evaluated as negative is a reliable indicator of the absence of sufficient plaque pathology in the brain to support a diagnosis of AD.” Existing tools to diagnose AD are not especially accurate, so being able to rule the disease out could be important. According to the researchers, “Consistent with previous studies, only 44 of 57 (77%) patients with a clinical diagnosis of AD in the present study were actually found to have” the condition.

One problem that the researchers encountered was that some of the patients had pronounced brain atrophy which made the visual assessment of the scans more difficult. The researchers suggest that another possible issue is that florbetaben F18, and other similar drugs, work differently in end-of-life patients than in earlier stage patients and would like further study to rule out that possiblity.

Despite those limitations, the Phase III trial results “support the value of florbetaben PET as a diagnostic marker, particularly as a valuable adjunct for the exclusion of AD or differential diagnosis of dementia.” Better diagnostic tools can lead to more appropriate treatment plans and a higher quality of end-of-life care for people with dementia and Alzheimer’s disease.