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.
OBJECTIVE
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.


METHODS
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.


METHODS
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
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.
LANVIE-Laboratory of Neuroimaging of Aging, University of Geneva, Geneva, Switzerland2Laboratory of Alzheimer's Neuroimaging and Epidemiology, Istituto di Ricovero e Cura a Carattere Scientifico Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy.
Marina
M
Boccardi
Laboratory of Alzheimer's Neuroimaging and Epidemiology, Istituto di Ricovero e Cura a Carattere Scientifico Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy3Department of Molecular and Translational Medicine, University of Brescia, Brescia, Italy.
Daniele
D
Altomare
Unit of Statistics, Istituto di Ricovero e Cura a Carattere Scientifico Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy.
Clarissa
C
Ferrari
Laboratory of Alzheimer's Neuroimaging and Epidemiology, Istituto di Ricovero e Cura a Carattere Scientifico Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy3Department of Molecular and Translational Medicine, University of Brescia, Brescia, Italy.
Cristina
C
Festari
Department of Nuclear Medicine, Poliambulanza Foundation, Brescia, Italy.
Ugo Paolo
UP
Guerra
Department of Nuclear Medicine, University of Brescia, Brescia, Italy.
Barbara
B
Paghera
Department of Nuclear Medicine, Poliambulanza Foundation, Brescia, Italy.
Claudio
C
Pizzocaro
Alzheimer's Unit, Memory Clinic, Istituto di Ricovero e Cura a Carattere Scientifico Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy.
Giulia
G
Lussignoli
Alzheimer's Unit, Memory Clinic, Istituto di Ricovero e Cura a Carattere Scientifico Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy.
Cristina
C
Geroldi
Alzheimer's Unit, Memory Clinic, Istituto di Ricovero e Cura a Carattere Scientifico Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy.
Orazio
O
Zanetti
Neurology Unit, Ospedale di Vallecamonica Esine, Brescia, Italy.
Maria Sofia
MS
Cotelli
Neurology Unit, Ospedale di Vallecamonica Esine, Brescia, Italy.
Marinella
M
Turla
Centre for Aging Brain and Neurodegenerative Disorders, Neurology Unit, University of Brescia, Brescia, Italy.
Barbara
B
Borroni
Centre for Aging Brain and Neurodegenerative Disorders, Neurology Unit, University of Brescia, Brescia, Italy.
Luca
L
Rozzini
European Foundation Biomedical Research, Center of Excellence Alzheimer, Ospedale Briolini, Gazzaniga, Bergamo, Italy.
Dario
D
Mirabile
European Foundation Biomedical Research, Center of Excellence Alzheimer, Ospedale Briolini, Gazzaniga, Bergamo, Italy.
Carlo
C
Defanti
Neurology Unit, Ospedale Maggiore di Crema, Cremona, Italy.
Michele
M
Gennuso
Neurology Unit, Ospedale Maggiore di Crema, Cremona, Italy.
Alessandro
A
Prelle
Department of Rehabilitation, Fondazione Teresa Camplani, Casa di cura Ancelle della Carità, Cremona, Italy.
Simona
S
Gentile
Department of Rehabilitation, Fondazione Teresa Camplani, Casa di cura Ancelle della Carità, Cremona, Italy.
Alessandro
A
Morandi
Neurology Unit, Istituto Clinico Città di Brescia, Brescia, Italy.
Stefano
S
Vollaro
Neurology Unit, Istituto Clinico Città di Brescia, Brescia, Italy.
Giorgio Dalla
GD
Volta
Department of Medicine and Rehabilitation, Istituto Clinico Sant'Anna, Brescia, Italy.
Angelo
A
Bianchetti
Hospice, Istituto Polifunzionale Sociosanitario Foundation Cardinal Giorgio Gusmini, Vertova, Bergamo, Italy.
Marta Zaffira
MZ
Conti
Hospice, Istituto Polifunzionale Sociosanitario Foundation Cardinal Giorgio Gusmini, Vertova, Bergamo, Italy.
Melania
M
Cappuccio
Alzheimer Evaluation Unit, Istituto Ospedaliero di Sospiro Non-Profit Organization of Social Utility Foundation, Sospiro, Cremona, Italy.
Pasqualina
P
Carbone
Alzheimer Evaluation Unit, Istituto Ospedaliero di Sospiro Non-Profit Organization of Social Utility Foundation, Sospiro, Cremona, Italy.
Daniele
D
Bellandi
Neurology Unit, Istituti Ospedalieri di Cremona, Cremona, Italy.
Luciano
L
Abruzzi
Neurology Unit, Istituti Ospedalieri di Cremona, Cremona, Italy.
Luigi
L
Bettoni
Alzheimer Evaluation Unit, Casa di Cura Figlie di S. Camillo, Cremona, Italy.
Daniele
D
Villani
Alzheimer Evaluation Unit, Casa di Cura Figlie di S. Camillo, Cremona, Italy.
Maria Clara
MC
Raimondi
Neurology Unit, Carlo Poma, Mantova, Italy.
Alessia
A
Lanari
Neurology Unit, Carlo Poma, Mantova, Italy.
Alfonso
A
Ciccone
Geriatric General Rehabilitation, Fondazione Richiedei, Palazzolo sull'Oglio, Brescia, Italy.
Emanuela
E
Facchi
Geriatric General Rehabilitation, Fondazione Richiedei, Palazzolo sull'Oglio, Brescia, Italy.
Ignazio
I
Di Fazio
Neurology Unit, Poliambulanza Foundation, Brescia, Italy.
Renzo
R
Rozzini
Neurology Unit, Poliambulanza Foundation, Brescia, Italy.
Stefano
S
Boffelli
Neuromotor and Cognitive Rehabilitation Center, Clinic Quarenghi, San Pellegrino Terme, Bergamo, Italy.
Laura
L
Manzoni
Neuromotor and Cognitive Rehabilitation Center, Clinic Quarenghi, San Pellegrino Terme, Bergamo, Italy.
Giovanni Pietro
GP
Salvi
Alzheimer Evaluation Unit, Hospice Santa Maria Ausiliatrice Onlus Foundation, Bergamo, Italy.
Sabina
S
Cavaliere
Alzheimer Evaluation Unit, Hospice Santa Maria Ausiliatrice Onlus Foundation, Bergamo, Italy.
Gloria
G
Belotti
Neuromotor Rehabilitation Medicine, Salvatore Maugeri Foundation Clinic of Work and Rehabilitation, Istituto di Ricovero e Cura a Carattere Scientifico, Castel Goffredo, Mantova, Italy.
Stefano
S
Avanzi
Service of Medical Statistics and Information Technology, Fatebenefratelli Foundation for Health Research and Education, Rome, Italy.
Patrizio
P
Pasqualetti
Laboratory of Alzheimer's Neuroimaging and Epidemiology, Istituto di Ricovero e Cura a Carattere Scientifico Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy26Division of Neurology V-Neuropathology, Fondazione, Istituto di Ricovero e Cura a Carattere Scientifico Istituto Neurologico Carlo Besta, Milan, Italy.
Cristina
C
Muscio
Centre for Aging Brain and Neurodegenerative Disorders, Neurology Unit, University of Brescia, Brescia, Italy.
Alessandro
A
Padovani
LANVIE-Laboratory of Neuroimaging of Aging, University of Geneva, Geneva, Switzerland2Laboratory of Alzheimer's Neuroimaging and Epidemiology, Istituto di Ricovero e Cura a Carattere Scientifico Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy27Memory Clinic, University Hospital of Geneva, Geneva, Switzerland.
Giovanni B
GB
Frisoni
D000368:Aged; D000369:Aged, 80 and over; D000544:Alzheimer Disease / Q000175:diagnosis* / Q000000981:diagnostic imaging / Q000378:metabolism; D016229:Amyloid beta-Peptides / Q000378:metabolism*; D000814:Aniline Compounds; D060825:Cognitive Dysfunction / Q000175:diagnosis* / Q000000981:diagnostic imaging / Q000378:metabolism; D005026:Ethylene Glycols; D005260:Female; D006801:Humans; D008297:Male; D049268:Positron-Emission Tomography / Q000379:methods / Q000592:standards*; D011237:Predictive Value of Tests
D016229:Amyloid beta-Peptides; D000814:Aniline Compounds; D005026:Ethylene Glycols; C545186:florbetapir