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Ligand compared with C-11 PiB Subjects Correlation of binding between ligands Diagnostic performance Florbetapir [55] 12 AD patients, 14 cognitively normal control subjects Composite cortical binding correlation r = 0.78, P < .001 Group discrimination florbetapir area under the curve = 0.90 vs PiB = 1.0. Florbetapir [56] 24 MCI subjects, 8 healthy control subjects Composite cortical binding correlation ρ = 0.95, P < .001, slope = 0.60 97% classification agreement using derived cut points Flutemetamol [48] 20 AD patients, 20 MCI subjects Composite cortical binding correlation r = 0.905, slope = 0.99 100% concordance of individual subject visual scan categorization between ligands Florbetaben [57] 10 AD patients, 10 healthy control subjects Composite cortical binding correlation r = 0.97, P < .0001, slope = 0.71 100% concordance of individual subject visual scan categorization between ligands NAV4694 [53] 7 AD patients, 3 patients with frontotemporal dementia, 10 MCI subjects, 25 healthy control subjects Composite cortical binding correlation r = 0.99, P < .0001, slope = 0.95 100% concordance of individual subject visual scan categorization between ligands Abbreviations: PiB, Pittsburgh compound B; AD, Alzheimer’s disease; MCI, mild cognitive impairment.
Scenario variable Variations considered Symptoms None Memory or cognitive complaint Clinical setting Nonmedical PCP Specialist Dementia specialist Clinical context Not applicable (nonmedical) Initial assessment Full evaluation, AD not suspected Full evaluation, AD suspected Evidence of deficit on examination Not applicable (nonmedical) None Yes MCI Mild—moderate dementia Severe dementia Family history of AD or apolipoprotein E ɛ4 positive Negative Positive AD genetic mutation carrier Negative Positive Not applicable Age <65 years >65 years Abbreviations: PCP, Primary Care Physician; AD, Alzheimer’s disease; MCI, mild cognitive impairment.
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Table of Relationships with Industry and Other Entities for Task Force Members and Outside Reviewers
Name Reported relationships with industry or other entities Bohnen, Nic • None Devous, Michael • Avid Pharmaceuticals • Lilly Healthcare • Bayer (now Piramal Pharmaceuticals) Donohoe, Kevin • None Drzezga, Alexander • Avid Radiopharmaceuticals/Lilly Healthcare • Bayer Healthcare • GE Healthcare • Siemens Healthcare Foster, Norman • Bristol-Meyers Squibb • GE Healthcare • Janssen AI • Center for Health Improvement Herholz, Karl • GE Healthcare • Elan • Avid Radiopharmaceuticals/Lilly Healthcare Herscovitch, Peter • None Johnson, Keith • Siemens • Avid Radiopharmaceuticals/Lilly Healthcare • Janssen AI • Bayer • Navidea Biopharmaceuticals • Piramal Healthcare Karlawish, Jason • Alzheimer’s Disease Cooperative Study (member) Minoshima, Satoshi • None Rabinovici, Gil • Avid Radiopharmaceuticals Rowe, Christopher • Bayer • GE Healthcare • AstraZeneca • Piramal Healthcare • Avid Radiopharmaceuticals/Lilly Healthcare • Navidea Biopharmaceuticals Villemagne, Victor • Bayer Wolk, David • Pfizer • GE Healthcare