TY - JOUR
T1 - Assessment of the Incremental Diagnostic Value of Florbetapir F 18 Imaging in Patients With Cognitive Impairment
T2 - The Incremental Diagnostic Value of Amyloid PET With [18F]-Florbetapir (INDIA-FBP) Study
AU - Boccardi, Marina
AU - Altomare, Daniele
AU - Ferrari, Clarissa
AU - Festari, Cristina
AU - Guerra, Ugo Paolo
AU - Paghera, Barbara
AU - Pizzocaro, Claudio
AU - Lussignoli, Giulia
AU - Geroldi, Cristina
AU - Zanetti, Orazio
AU - Cotelli, Maria Sofia
AU - Turla, Marinella
AU - Borroni, Barbara
AU - Rozzini, Luca
AU - Mirabile, Dario
AU - Defanti, Carlo
AU - Gennuso, Michele
AU - Prelle, Alessandro
AU - Gentile, Simona
AU - Morandi, Alessandro
AU - Vollaro, Stefano
AU - Volta, Giorgio Dalla
AU - Bianchetti, Angelo
AU - Conti, Marta Zaffira
AU - Cappuccio, Melania
AU - Carbone, Pasqualina
AU - Bellandi, Daniele
AU - Abruzzi, Luciano
AU - Bettoni, Luigi
AU - Villani, Daniele
AU - Raimondi, Maria Clara
AU - Lanari, Alessia
AU - Ciccone, Alfonso
AU - Facchi, Emanuela
AU - Di Fazio, Ignazio
AU - Rozzini, Renzo
AU - Boffelli, Stefano
AU - Manzoni, Laura
AU - Salvi, Giovanni Pietro
AU - Cavaliere, Sabina
AU - Belotti, Gloria
AU - Avanzi, Stefano
AU - Pasqualetti, Patrizio
AU - Muscio, Cristina
AU - Padovani, Alessandro
AU - Frisoni, Giovanni B
AU - Incremental Diagnostic Value of Amyloid PET With [18F]-Florbetapir (INDIA-FBP) Working Group
PY - 2016/12/1
Y1 - 2016/12/1
N2 - 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 of Amyloid 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 impairment were 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 diagnosis was made, diagnostic confidence was estimated, and drug treatment was provided. At the time of this workup, an amyloid PET/computed tomographic scan was performed, and the result was communicated to physicians after workup completion. Physicians were asked to review the diagnosis, diagnostic confidence, and treatment after the scan. The study was conducted from August 5, 2013, to December 31, 2014.Main Outcomes and Measures: Primary outcomes were 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.
AB - 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 of Amyloid 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 impairment were 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 diagnosis was made, diagnostic confidence was estimated, and drug treatment was provided. At the time of this workup, an amyloid PET/computed tomographic scan was performed, and the result was communicated to physicians after workup completion. Physicians were asked to review the diagnosis, diagnostic confidence, and treatment after the scan. The study was conducted from August 5, 2013, to December 31, 2014.Main Outcomes and Measures: Primary outcomes were 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.
KW - Journal Article
U2 - 10.1001/jamaneurol.2016.3751
DO - 10.1001/jamaneurol.2016.3751
M3 - Article
C2 - 27802513
VL - 73
SP - 1417
EP - 1424
JO - JAMA Neurology
JF - JAMA Neurology
SN - 2168-6149
IS - 12
ER -