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

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.; Morandi, A.; Vollaro, S.; Volta, G. D.; Bianchetti, A.; Conti, M. Z.; Cappuccio, M.; Carbone, P.; Bellandi, D.; Abruzzi, L.; Bettoni, L.; Villani, D.; Raimondi, M. C.; Lanari, A.; Ciccone, A.; Facchi, E.; Di Fazio, I.; Rozzini, R.; Boffelli, S.; Manzoni, L.; Salvi, G. P.; Cavaliere, S.; Belotti, G.; Avanzi, S.; Pasqualetti, P.; Muscio, C.; Padovani, A.; Frisoni, G. B.; Antelmi, L.; Galluzzi, S.; Pievani, M.; Redolfi, A.; Tarallo, A.; Arora, A.; Bertocchi, M.; Chito, E.; Moretti, D. V.; Giubbini, R.; Rodella, C.; Camoni, L.; Massetti, V.; Andreoli, M.; Bellelli, G.; Fascendini, S.; Mattioli, F.; Turco, R.; Vezzadini, G.; Raimondi, V.; Mondini, S.; Zanacchi, E. C.; Grigolo, M.; Pezzini, A.; Bilotti, G.; Bigni, B.; Zavarise, P.; Ngonga, G.; Anzola, G. P.; Turrone, R.; Guizzetti, G.; Zanetti, M.

doi:10.1001/jamaneurol.2016.3751

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.

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 / 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.; Morandi, A.; Vollaro, S.; Volta, G. D.; Bianchetti, A.; Conti, M. Z.; Cappuccio, M.; Carbone, P.; Bellandi, D.; Abruzzi, L.; Bettoni, L.; Villani, D.; Raimondi, M. C.; Lanari, A.; Ciccone, A.; Facchi, E.; Di Fazio, I.; Rozzini, R.; Boffelli, S.; Manzoni, L.; Salvi, G. P.; Cavaliere, S.; Belotti, G.; Avanzi, S.; Pasqualetti, P.; Muscio, C.; Padovani, A.; Frisoni, G. B.; Antelmi, L.; Galluzzi, S.; Pievani, M.; Redolfi, A.; Tarallo, A.; Arora, A.; Bertocchi, M.; Chito, E.; Moretti, D. V.; Giubbini, R.; Rodella, C.; Camoni, L.; Massetti, V.; Andreoli, M.; Bellelli, G.; Fascendini, S.; Mattioli, F.; Turco, R.; Vezzadini, G.; Raimondi, V.; Mondini, S.; Zanacchi, E. C.; Grigolo, M.; Pezzini, A.; Bilotti, G.; Bigni, B.; Zavarise, P.; Ngonga, G.; Anzola, G. P.; Turrone, R.; Guizzetti, G.; Zanetti, M.. - In: JAMA NEUROLOGY. - ISSN 2168-6149. - 73:12(2016), pp. 1417-1424. [10.1001/jamaneurol.2016.3751]