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JAMA Neurol. 2016 Dec 1;73(12):1417-1424. doi: 10.1001/jamaneurol.2016.3751.

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.

Author information

1
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.
2
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.
3
Unit of Statistics, Istituto di Ricovero e Cura a Carattere Scientifico Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy.
4
Department of Nuclear Medicine, Poliambulanza Foundation, Brescia, Italy.
5
Department of Nuclear Medicine, University of Brescia, Brescia, Italy.
6
Alzheimer's Unit, Memory Clinic, Istituto di Ricovero e Cura a Carattere Scientifico Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy.
7
Neurology Unit, Ospedale di Vallecamonica Esine, Brescia, Italy.
8
Centre for Aging Brain and Neurodegenerative Disorders, Neurology Unit, University of Brescia, Brescia, Italy.
9
European Foundation Biomedical Research, Center of Excellence Alzheimer, Ospedale Briolini, Gazzaniga, Bergamo, Italy.
10
Neurology Unit, Ospedale Maggiore di Crema, Cremona, Italy.
11
Department of Rehabilitation, Fondazione Teresa Camplani, Casa di cura Ancelle della Carità, Cremona, Italy.
12
Neurology Unit, Istituto Clinico Città di Brescia, Brescia, Italy.
13
Department of Medicine and Rehabilitation, Istituto Clinico Sant'Anna, Brescia, Italy.
14
Hospice, Istituto Polifunzionale Sociosanitario Foundation Cardinal Giorgio Gusmini, Vertova, Bergamo, Italy.
15
Alzheimer Evaluation Unit, Istituto Ospedaliero di Sospiro Non-Profit Organization of Social Utility Foundation, Sospiro, Cremona, Italy.
16
Neurology Unit, Istituti Ospedalieri di Cremona, Cremona, Italy.
17
Alzheimer Evaluation Unit, Casa di Cura Figlie di S. Camillo, Cremona, Italy.
18
Neurology Unit, Carlo Poma, Mantova, Italy.
19
Geriatric General Rehabilitation, Fondazione Richiedei, Palazzolo sull'Oglio, Brescia, Italy.
20
Neurology Unit, Poliambulanza Foundation, Brescia, Italy.
21
Neuromotor and Cognitive Rehabilitation Center, Clinic Quarenghi, San Pellegrino Terme, Bergamo, Italy.
22
Alzheimer Evaluation Unit, Hospice Santa Maria Ausiliatrice Onlus Foundation, Bergamo, Italy.
23
Neuromotor Rehabilitation Medicine, Salvatore Maugeri Foundation Clinic of Work and Rehabilitation, Istituto di Ricovero e Cura a Carattere Scientifico, Castel Goffredo, Mantova, Italy.
24
Service of Medical Statistics and Information Technology, Fatebenefratelli Foundation for Health Research and Education, Rome, Italy.
25
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.
26
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.

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 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.

PMID:
27802513
DOI:
10.1001/jamaneurol.2016.3751
[Indexed for MEDLINE]

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