Elisabeth K Degenhardt1, Michael M Witte2, Michael G Case3, Peng Yu3, David B Henley4, Helen M Hochstetler5, Deborah N D'Souza6, Paula T Trzepacz7. 1. IU Health Physicians Group, Department of Psychiatry, Indiana University School of Medicine Collaboration, Indiana University Health, Indianapolis, IN. 2. Lilly USA, LLC, Neurosciences, Indianapolis, IN. 3. Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN. 4. Lilly USA, LLC, Neurosciences, Indianapolis, IN; Department of Psychiatry, Indiana University School of Medicine, Indianapolis, IN. 5. Lilly USA, LLC, Neurosciences, Indianapolis, IN. Electronic address: hochstetler_helen_m@lilly.com. 6. inVentiv Health, LLC, Burlington, MA. 7. Department of Psychiatry, Indiana University School of Medicine, Indianapolis, IN.
Abstract
BACKGROUND: Clinical diagnosis of Alzheimer disease (AD) is challenging, with a 70.9%-87.3% sensitivity and 44.3%-70.8% specificity, compared with autopsy diagnosis. Florbetapir F18 positron emission tomography (FBP-PET) estimates beta-amyloid plaque density antemortem. METHODS: Of 2052 patients (≥55 years old) clinically diagnosed with mild or moderate AD dementia from 2 solanezumab clinical trials, 390 opted to participate in a FBP-PET study addendum. We analyzed baseline prerandomization characteristics. RESULTS: A total of 22.4% had negative FBP-PET scans, whereas 72.5% of mild and 86.9% of moderate AD patients had positive results. No baseline clinical variable reliably differentiated negative from positive FBP-PET scan groups. CONCLUSIONS: These data confirm the challenges of correctly diagnosing AD without using biomarkers. FBP-PET can aid AD dementia differential diagnosis by detecting amyloid pathology antemortem, even when the diagnosis of AD is made by expert clinicians.
BACKGROUND: Clinical diagnosis of Alzheimer disease (AD) is challenging, with a 70.9%-87.3% sensitivity and 44.3%-70.8% specificity, compared with autopsy diagnosis. FlorbetapirF18 positron emission tomography (FBP-PET) estimates beta-amyloid plaque density antemortem. METHODS: Of 2052 patients (≥55 years old) clinically diagnosed with mild or moderate AD dementia from 2 solanezumab clinical trials, 390 opted to participate in a FBP-PET study addendum. We analyzed baseline prerandomization characteristics. RESULTS: A total of 22.4% had negative FBP-PET scans, whereas 72.5% of mild and 86.9% of moderate ADpatients had positive results. No baseline clinical variable reliably differentiated negative from positive FBP-PET scan groups. CONCLUSIONS: These data confirm the challenges of correctly diagnosing AD without using biomarkers. FBP-PET can aid AD dementia differential diagnosis by detecting amyloid pathology antemortem, even when the diagnosis of AD is made by expert clinicians.
Authors: J Cummings; G D Rabinovici; A Atri; P Aisen; L G Apostolova; S Hendrix; M Sabbagh; D Selkoe; M Weiner; S Salloway Journal: J Prev Alzheimers Dis Date: 2022
Authors: John A Hey; Jeremy Y Yu; Mark Versavel; Susan Abushakra; Petr Kocis; Aidan Power; Paul L Kaplan; John Amedio; Martin Tolar Journal: Clin Pharmacokinet Date: 2018-03 Impact factor: 6.447