“The advent of disease-modifying therapies has accelerated the need for early diagnosis since diagnostic delays for Alzheimer’s disease could adversely affect outcomes,” said Heather Nelson, PhD, DABCC, ARUP medical director of Clinical Chemistry. “This test offers a less invasive and more accessible way to provide evidence of AD pathology than alternate means.”
According to the Alzheimer’s Association, AD is the most common cause of dementia, accounting for 60–80% of cases, and brain changes may begin 20 years or more before symptoms start. These brain changes include the accumulation of beta-amyloid and tau proteins.
ARUP validated the pTau 217 test using carefully characterized samples from Eli Lilly and Company’s Phase 3 TRAILBLAZER-ALZ 2 trial. The validation cohort included blood specimens and results from amyloid positron emission tomography (amyloid-PET) imaging of 524 individuals.