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

被引:80
作者
Boccardi, Marina [1 ,2 ]
Altomare, Daniele [2 ,3 ]
Ferrari, Clarissa [2 ,4 ]
Festari, Cristina [3 ]
Guerra, Ugo Paolo [5 ]
Paghera, Barbara [6 ]
Pizzocaro, Claudio [5 ]
Lussignoli, Giulia [7 ]
Geroldi, Cristina [7 ]
Zanetti, Orazio [7 ]
Cotelli, Maria Sofia [8 ]
Turla, Marinella [8 ]
Borroni, Barbara [9 ]
Rozzini, Luca [9 ]
Mirabile, Dario [10 ]
Defanti, Carlo [10 ]
Gennuso, Michele [11 ]
Prelle, Alessandro [11 ]
Gentile, Simona [12 ]
Morandi, Alessandro [12 ]
Vollaro, Stefano [13 ]
Dalla Volta, Giorgio [13 ]
Bianchetti, Angelo [14 ]
Conti, Marta Zaffira [15 ]
Cappuccio, Melania [15 ]
Carbone, Pasqualina [16 ]
Bellandi, Daniele [16 ]
Abruzzi, Luciano [17 ]
Bettoni, Luigi [17 ]
Villani, Daniele [18 ]
Raimondi, Maria Clara [18 ]
Lanari, Alessia [19 ]
Ciccone, Alfonso [19 ]
Facchi, Emanuela [20 ]
Di Fazio, Ignazio [20 ]
Rozzini, Renzo [21 ]
Boffelli, Stefano [21 ]
Manzoni, Laura [22 ]
Salvi, Giovanni Pietro [22 ]
Cavaliere, Sabina [23 ]
Belotti, Gloria [23 ]
Avanzi, Stefano [24 ]
Pasqualetti, Patrizio [25 ]
Muscio, Cristina [2 ,26 ]
Padovani, Alessandro [9 ]
Frisoni, Giovanni B. [1 ,2 ,27 ]
机构
[1] Univ Geneva, LANVIE Lab Neuroimaging Aging, Chemin Petit Bel Air 2,Batiment Voirons, CH-1225 Geneva, Switzerland
[2] Ctr San Giovanni Dio Fatebenefratelli, Ist Ricovero & Cura Carattere Sci, Lab Alzheimers Neuroimaging & Epidemiol, Brescia, Italy
[3] Univ Brescia, Dept Mol & Translat Med, Brescia, Italy
[4] Ctr San Giovanni Dio Fatebenefratelli, Ist Ricovero & Cura Carattere Sci, Unit Stat, Brescia, Italy
[5] Poliambulanza Fdn, Dept Nucl Med, Brescia, Italy
[6] Univ Brescia, Dept Nucl Med, Brescia, Italy
[7] Ctr San Giovanni Dio Fatebenefratelli, Ist Ricovero & Cura Carattere Sci, Alzheimers Unit, Memory Clin, Brescia, Italy
[8] Osped Vallecamon Esine, Neurol Unit, Brescia, Italy
[9] Univ Brescia, Neurol Unit, Ctr Aging Brain & Neurodegenerat Disorders, Brescia, Italy
[10] Osped Briolini, Ctr Excellence Alzheimer, European Fdn Biomed Res, Bergamo, Italy
[11] Osped Maggiore Crema, Neurol Unit, Cremona, Italy
[12] Casa Cura Ancelle Carita, Fdn Teresa Camplani, Dept Rehabil, Cremona, Italy
[13] Ist Clin Citta Brescia, Neurol Unit, Brescia, Italy
[14] Ist Clin St Anna, Dept Med & Rehabil, Brescia, Italy
[15] Ist Polifunz Sociosanit Fdn Cardinal Giorgio Gusm, Hosp, Bergamo, Italy
[16] Social Util Fdn, Nonprofit Org, Ist Osped Sospiro, Alzheimer Evaluat Unit, Sospiro, Cremona, Italy
[17] Ist Osped Cremona, Neurol Unit, Cremona, Italy
[18] Casa Cura Figlie S Camillo, Alzheimer Evaluat Unit, Cremona, Italy
[19] Carlo Poma, Neurol Unit, Mantua, Italy
[20] Fdn Richiedei, Geriatr Gen Rehabil, Brescia, Italy
[21] Poliambulanza Fdn, Neurol Unit, Brescia, Italy
[22] Clin Quarenghi, Neuromotor & Cognit Rehabil Ctr, Bergamo, Italy
[23] Hosp Santa Maria, Alzheimer Evaluat Unit, Bergamo, Italy
[24] Ist Ricovero & Cura Carattere Sci, Salvatore Maugeri Fdn, Clin Work & Rehabil, Neuromotor Rehabil Med, Castel Goffredo, Mantova, Italy
[25] Fatebenefratelli Fdn Hlth Res & Educ, Serv Med Stat & Informat Technol, Rome, Italy
[26] Ist Ricovero & Cura Carattere Sci, Ist Neurol Carlo Besta, Div Neurol Neuropathol 5, Milan, Italy
[27] Univ Hosp Geneva, Memory Clin, Geneva, Switzerland
关键词
MODERATE ALZHEIMER DEMENTIA; BETA PLAQUES; DISEASE; IMPACT; DONEPEZIL; RECOMMENDATIONS; HYPOTHESIS; CRITERIA; AUTOPSY; STATE;
D O I
10.1001/jamaneurol.2016.3751
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
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 [F-18]-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.
引用
收藏
页码:1417 / 1424
页数:8
相关论文
共 40 条
[1]   The diagnosis of mild cognitive impairment due to Alzheimer's disease: Recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease [J].
Albert, Marilyn S. ;
DeKosky, Steven T. ;
Dickson, Dennis ;
Dubois, Bruno ;
Feldman, Howard H. ;
Fox, Nick C. ;
Gamst, Anthony ;
Holtzman, David M. ;
Jagust, William J. ;
Petersen, Ronald C. ;
Snyder, Peter J. ;
Carrillo, Maria C. ;
Thies, Bill ;
Phelps, Creighton H. .
ALZHEIMERS & DEMENTIA, 2011, 7 (03) :270-279
[2]   World Medical Association Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects [J].
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2013, 310 (20) :2191-2194
[3]   Donepezil-Induced Confusional State in a Patient With Autopsy-Proven Behavioral-Variant Frontotemporal Dementia [J].
Arciniegas, David B. ;
Anderson, C. Alan .
JOURNAL OF NEUROPSYCHIATRY AND CLINICAL NEUROSCIENCES, 2013, 25 (03) :E25-E26
[4]   Technical performance of a novel, fully automated electrochemiluminescence immunoassay for the quantitation of β-amyloid (1-42) in human cerebrospinal fluid [J].
Bittner, Tobias ;
Zetterberg, Henrik ;
Teunissen, Charlotte E. ;
Ostlund, Richard E., Jr. ;
Militello, Michael ;
Andreasson, Ulf ;
Hubeek, Isabelle ;
Gibson, David ;
Chu, David C. ;
Eichenlaub, Udo ;
Heiss, Peter ;
Kobold, Uwe ;
Leinenbach, Andreas ;
Madin, Kairat ;
Manuilova, Ekaterina ;
Rabe, Christina ;
Blennow, Kaj .
ALZHEIMERS & DEMENTIA, 2016, 12 (05) :517-526
[5]   Do Beliefs about the Pathogenetic Role of Amyloid Affect the Interrpretatrion of Amyloid PET on the clinic? [J].
Boccardi, Marina ;
Altomare, Daniele ;
Ferrari, Clarissa ;
Festari, Cristina ;
Antelmi, Luigi ;
Pievani, Michela ;
Tarallo, Anna ;
Muscio, Cristina ;
Guerra, Ugo P. ;
Paghera, Barbara ;
Padovani, Alessandro ;
Frisoni, Giovanni B. .
NEURODEGENERATIVE DISEASES, 2016, 16 (1-2) :111-117
[6]   Memantine in patients with frontotemporal lobar degeneration: a multicentre, randomised, double-blind, placebo-controlled trial [J].
Boxer, Adam L. ;
Knopman, David S. ;
Kaufer, Daniel I. ;
Grossman, Murray ;
Onyike, Chiadi ;
Graf-Radford, Neill ;
Mendez, Mario ;
Kerwin, Diana ;
Lerner, Alan ;
Wu, Chuang-Kuo ;
Koestler, Maly ;
Shapira, Jill ;
Sullivan, Kathryn ;
Klepac, Kristen ;
Lipowski, Kristine ;
Ullah, Jerin ;
Fields, Scott ;
Kramer, Joel H. ;
Merrilees, Jennifer ;
Neuhaus, John ;
Mesulam, M. Marsel ;
Miller, Bruce L. .
LANCET NEUROLOGY, 2013, 12 (02) :149-156
[7]  
Clark CM, 2012, LANCET NEUROL, V11, P669, DOI 10.1016/S1474-4422(12)70142-4
[8]   Advancing research diagnostic criteria for Alzheimer's disease: the IWG-2 criteria [J].
Dubois, Bruno ;
Feldman, Howard H. ;
Jacova, Claudia ;
Hampel, Harald ;
Molinuevo, Jose Luis ;
Blennow, Kaj ;
Dekosky, Steven T. ;
Gauthier, Serge ;
Selkoe, Dennis ;
Bateman, Randall ;
Cappa, Stefano ;
Crutch, Sebastian ;
Engelborghs, Sebastiaan ;
Frisoni, Giovanni B. ;
Fox, Nick C. ;
Galasko, Douglas ;
Habert, Marie-Odile ;
Jicha, Gregory A. ;
Nordberg, Agneta ;
Pasquier, Florence ;
Rabinovici, Gil ;
Robert, Philippe ;
Rowe, Christopher ;
Salloway, Stephen ;
Sarazin, Marie ;
Epelbaum, Stephane ;
de Souza, Leonardo C. ;
Vellas, Bruno ;
Visser, Pieter J. ;
Schneider, Lon ;
Stern, Yaakov ;
Scheltens, Philip ;
Cummings, Jeffrey L. .
LANCET NEUROLOGY, 2014, 13 (06) :614-629
[9]   Efficacy of galantamine in probable vascular dementia and Alzheimer's disease combined with cerebrovascular disease: a randomised trial [J].
Erkinjuntti, T ;
Kurz, A ;
Gauthier, S ;
Bullock, R ;
Lilienfeld, S ;
Damaraju, CV .
LANCET, 2002, 359 (9314) :1283-1290
[10]   MINI-MENTAL STATE - PRACTICAL METHOD FOR GRADING COGNITIVE STATE OF PATIENTS FOR CLINICIAN [J].
FOLSTEIN, MF ;
FOLSTEIN, SE ;
MCHUGH, PR .
JOURNAL OF PSYCHIATRIC RESEARCH, 1975, 12 (03) :189-198