Assessment of the incremental diagnostic value of florbetapir F 18 imaging in patients with cognitive impairment: The incremental diagnostic value of amyloid PET with [18F]-florbetapir (INDIA-FBP) study

Marina Boccardi, Daniele Altomare, Clarissa Ferrari, Cristina Festari, Ugo Paolo Guerra, Barbara Paghera, Claudio Pizzocaro, Giulia Lussignoli, Cristina Geroldi, Orazio Zanetti, Maria Sofia Cotelli, Marinella Turla, Barbara Borroni, Luca Rozzini, Dario Mirabile, Carlo Defanti, Michele Gennuso, Alessandro Prelle, Simona Gentile, Alessandro MorandiStefano Vollaro, Giorgio Dalla Volta, Angelo Bianchetti, Marta Zaffira Conti, Melania Cappuccio, Pasqualina Carbone, Daniele Bellandi, Luciano Abruzzi, Luigi Bettoni, Daniele Villani, Maria Clara Raimondi, Alessia Lanari, Alfonso Ciccone, Emanuela Facchi, Ignazio Di Fazio, Renzo Rozzini, Stefano Boffelli, Laura Manzoni, Giovanni Pietro Salvi, Sabina Cavaliere, Gloria Belotti, Stefano Avanzi, Patrizio Pasqualetti, Cristina Muscio, Alessandro Padovani, Giovanni B. Frisoni, Luigi Antelmi, Samantha Galluzzi, Michela Pievani, Alberto Redolfi, Anna Tarallo, Anupa Arora, Monica Bertocchi, Eugenia Chitò, Davide V. Moretti, Raffaele Giubbini, Carlo Rodella, Luca Camoni, Valentina Massetti, Michela Andreoli, Giuseppe Bellelli, Sara Fascendini, Flavia Mattioli, Renato Turco, Giuliana Vezzadini, Vanessa Raimondi, Sara Mondini, Elisa Carolina Zanacchi, Marta Grigolo, Alessandra Pezzini, Giacinta Bilotti, Barbara Bigni, Paola Zavarise, Gael Ngonga, Gian Paolo Anzola, Rosanna Turrone, Gianluca Guizzetti, Marina Zanetti

Research output: Contribution to journalArticle

Abstract

IMPORTANCE Cerebral amyloidosis is a key abnormality in Alzheimer disease (AD) and can be detected in vivo with positron emission tomography (PET) ligands. Although amyloid PET has clearly demonstrated analytical validity, its clinical utility is debated. OBJECTIVE To evaluate the incremental diagnostic value of amyloid PET with florbetapir F 18 in addition to the routine clinical diagnostic assessment of patients evaluated for cognitive impairment. DESIGN, SETTING, AND PARTICIPANTS The Incremental Diagnostic Value ofAmyloid PET With [18F]-Florbetapir (INDIA-FBP) Study is a multicenter study involving 18 AD evaluation units from eastern Lombardy, Northern Italy, 228 consecutive adults with cognitive impairmentwere evaluated for AD and other causes of cognitive decline, with a prescan diagnostic confidence of AD between 15%and 85%. Participants underwent routine clinical and instrumental diagnostic assessment. A prescan diagnosiswas made, diagnostic confidencewas estimated, and drug treatmentwas provided. At the time of thisworkup, an amyloid PET/computed tomographic scanwas performed, and the resultwas communicated to physicians afterworkup completion. Physicianswere asked to review the diagnosis, diagnostic confidence, and treatment after the scan. The studywas conducted from August 5, 2013, to December 31, 2014. MAIN OUTCOMES AND MEASURES Primary outcomeswere prescan to postscan changes of diagnosis, diagnostic confidence, and treatment. RESULTS Of the 228 participants, 107 (46%) were male; mean (SD) age was 70.5 (7) years. Diagnostic change occurred in 46 patients (79%) having both a previous diagnosis of AD and an amyloid-negative scan (P < .001) and in 16 (53%) of those with non-AD diagnoses and an amyloid-positive scan (P < .001). Diagnostic confidence in AD diagnosis increased by 15.2%in amyloid-positive (P < .001; effect size Cohen d = 1.04) and decreased by 29.9%in amyloid-negative (P < .001; d = -1.19) scans. Acetylcholinesterase inhibitors and memantine hydrochloride were introduced in 61 (65.6%) patients with positive scan results who had not previously received those drugs, and the use of the drugs was discontinued in 6 (33.3%) patients with negative scan results who were receiving those drugs (P < .001). CONCLUSIONS AND RELEVANCE Amyloid PET in addition to routine assessment in patients with cognitive impairment has a significant effect on diagnosis, diagnostic confidence, and drug treatment. The effect on health outcomes, such as morbidity and mortality, remains to be assessed.

Original languageEnglish
Pages (from-to)1417-1424
Number of pages8
JournalJAMA Neurology
Volume73
Issue number12
DOIs
Publication statusPublished - 2016

ASJC Scopus subject areas

  • Clinical Neurology

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    Boccardi, M., Altomare, D., Ferrari, C., Festari, C., Guerra, U. P., Paghera, B., Pizzocaro, C., Lussignoli, G., Geroldi, C., Zanetti, O., Cotelli, M. S., Turla, M., Borroni, B., Rozzini, L., Mirabile, D., Defanti, C., Gennuso, M., Prelle, A., Gentile, S., ... Zanetti, M. (2016). Assessment of the incremental diagnostic value of florbetapir F 18 imaging in patients with cognitive impairment: The incremental diagnostic value of amyloid PET with [18F]-florbetapir (INDIA-FBP) study. JAMA Neurology, 73(12), 1417-1424. https://doi.org/10.1001/jamaneurol.2016.3751