A multicenter phase 2 study has found that 18F-flutemetamol PET is a potential biomarker for AD-related amyloidosis, according to the results presented on April 16 at the American Academy of Neurology (AAN) conference in Toronto.
The objective of the phase 2 study, sponsored by GE Healthcare, was to determine the efficacy of visual assessments of 18F-flutemetamol scans in assigning patients with clinically probable Alzheimer’s disease or amnestic mild cognitive impairment (MCI) and healthy controls to a ‘raised’ versus ‘normal’ uptake category, with the clinical diagnosis as standard of truth.
In the study, 27 patients with early-stage Alzheimer’s disease, 20 with MCI, 15 healthy controls above and 10 below 55 years participated. Dynamic scanning from 90-120 min post-injection was performed at 3 centres. 11C-PIB PET was also performed in 20 of the Alzheimer’s disease and 20 of the MCI cases.
Visual assessment assigned 25/27 scans from the Alzheimer’s disease group to the ‘raised’ category, 1/15 scans from the elderly healthy controls, and 9/20 scans from the MCI group, according to Rik Vandenberghe, MD, PhD, principal investigator of the trial and professor of neurology at the University Hospital Gasthuisberg in Leuven, Belgium.
Vandenberghe and colleagues also found the sensitivity and specificity with clinical diagnosis as standard of truth (Alzheimer’s disease versus healthy controls) was 92.6 percent and 96 percent, respectively. The correlation coefficient between 18F flutemetamol and 11C-PIB was 0.94.
This phase 2 study met its primary outcome and supported the role for 18F-flutemetamol PET as a potential biomarker for Alzheimer’s disease -related amyloidosis, concluded the researchers.