To report the FDA approval of florquinitau F18 injection (TAUKLARIFY) for tau PET imaging in adults with cognitive impairment undergoing evaluation for Alzheimer’s disease.
Approach:
Study Design: Two blinded read studies evaluated TAUKLARIFY PET images from over 500 participants across three clinical trials, including those with mild cognitive impairment, mild Alzheimer’s disease dementia, and cognitively unimpaired participants.
Image Assessment: Independent readers assessed scans while blinded to clinical information and amyloid beta PET results, classifying them as positive or negative for tau neurofibrillary tangle pathology.
Key Findings:
Study 1 showed positive percent agreement of 80% to 88% and negative percent agreement of 98% to 99% across 279 participants.
Study 2 showed positive percent agreement of 68% to 82% and negative percent agreement of 93% to 99% across 338 participants.
High inter-reader agreement was observed in both studies.
Safety assessment in 1,734 participants reported low incidence of headache (0.7%), nausea (0.2%), and other minor reactions (0.1%).
Interpretation:
TAUKLARIFY may perform less effectively in identifying tau pathology in earlier stages of the disease, and negative results do not exclude the presence of tau neurofibrillary tangle pathology.
Limitations:
TAUKLARIFY contributes to cumulative radiation exposure, which is linked to a higher cancer risk.
Safety and effectiveness for evaluating non-Alzheimer’s disease tauopathies have not been established.
Conclusion:
Positive and negative scan results should be interpreted within the context of the full clinical evaluation.
Machine-learning models trained on routine patient-physician conversations achieved similar performance in development and external validation cohorts in predicting cognitive impairment.
