Cited by 333Dementia and Cognitive Impairment ResearchAlzheimer's disease research and treatmentsMedical Imaging Techniques and Applications

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Phase 3 Trial of Flutemetamol Labeled With Radioactive Fluorine 18 Imaging and Neuritic Plaque Density

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Curtis, Craig, Gamez, Jose E., Singh, Upinder, Sadowsky, Carl H., Villena, Teresa, Sabbagh, Marwan N., Beach, Thomas G., Duara, Ranjan, Fleisher, Adam S., Frey, Kirk A., Walker, Zuzana, Hunjan, Arvinder, Holmes, Clive, Escovar, Yavir M., Vera, Carla X., Agronin, Marc E., Ross, Joel, Bozoki, Andrea, Akinola, Mary, Shi, Jiong, Vandenberghe, Rik, Ikonomovic, Milos D., Sherwin, Paul F., Grachev, Igor D., Farrar, Gillian, Smith, Adrian P. L., Buckley, Christopher J., McLain, Richard, Salloway, Stephen·2015·JAMA Neurology

DOI 10.1001/jamaneurol.2014.4144

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Abstract

IMPORTANCE: In vivo imaging of brain β-amyloid, a hallmark of Alzheimer disease, may assist in the clinical assessment of suspected Alzheimer disease. OBJECTIVE: To determine the sensitivity and specificity of positron emission tomography imaging with flutemetamol injection labeled with radioactive fluorine 18 to detect β-amyloid in the brain using neuropathologically determined neuritic plaque levels as the standard of truth. DESIGN, SETTING, AND PARTICIPANTS: Open-label multicenter imaging study that took place at dementia clinics, memory centers, and hospice centers in the United States and England from June 22, 2010, to November 23, 2011. Participants included terminally ill patients who were 55 years or older with a life expectancy of less than 1 year. INTERVENTIONS: Flutemetamol injection labeled with radioactive fluorine 18 (Vizamyl; GE Healthcare) administration followed by positron emission tomography imaging and subsequent brain donation. MAIN OUTCOMES AND MEASURES: Sensitivity and specificity of flutemetamol injection labeled with radioactive fluorine 18 positron emission tomography imaging for brain β-amyloid. Images were reviewed without and with computed tomography scans and classified as positive or negative for β-amyloid by 5 readers who were blind to patient information. In patients who died, neuropathologically determined neuritic plaque levels were used to confirm scan interpretations and determine sensitivity and specificity. RESULTS: Of 176 patients with evaluable images, 68 patients (38%) died during the study, were autopsied, and had neuritic plaque levels determined; 25 brains (37%) were β-amyloid negative; and 43 brains (63%) were β-amyloid positive. Imaging was performed a mean of 3.5 months (range, 0 to 13 months) before death. Sensitivity without computed tomography was 81% to 93% (median, 88%). Median specificity was 88%, with 4 of 5 of the readers having specificity greater than 80%. When scans were interpreted with computed tomography images, sensitivity and specificity improved for most readers but the differences were not significant. The area under the receiver operating curve was 0.90. There were no clinically meaningful findings in safety parameters. CONCLUSIONS AND RELEVANCE: This study showed that flutemetamol injection labeled with radioactive fluorine 18 was safe and had high sensitivity and specificity in an end-of-life population. In vivo detection of brain β-amyloid plaque density may increase diagnostic accuracy in cognitively impaired patients.

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Authors: Curtis, C., Gamez, J. E., Singh, U., Sadowsky, C. H., Villena, T., Sabbagh, M. N., Beach, T. G., Duara, R., Fleisher, A. S., Frey, K. A., Walker, Z., Hunjan, A., Holmes, C., Escovar, Y. M., Vera, C. X., Agronin, M. E., Ross, J., Bozoki, A., Akinola, M., Shi, J., Vandenberghe, R., Ikonomovic, M. D., Sherwin, P. F., Grachev, I. D., Farrar, G., Smith, A. P. L., Buckley, C. J., McLain, R., & Salloway, S.
Affiliations: Compass Research (US)
Galiz Research, Miami Springs, Florida
Geriatric Solutions, Las Vegas, Nevada
Nova Southeastern University (US)
Premiere Research Institute (US)
Banner Sun Health Research Institute (US)
Mount Sinai Medical Center (US)
University of California San Diego (US)
University of Michigan (US)
University College London (GB)
North Essex Partnership University NHS Foundation Trust, Essex, England
University of Southampton (GB)
VERITAS Research, Miami Lakes, Florida
University of Miami (US)
Memory Enhancement Center of America (US)
Michigan State University (US)
Kennington Health Centre, Oxford, England
Barrow Neurological Institute (US)
Universitair Ziekenhuis Leuven (BE)
Department of Neurology, University of Pittsburgh, Pittsburgh, Pennsylvania
Medical Affairs, GE Healthcare–Life Sciences, Princeton, New Jersey
Novartis (United States) (US)
Amersham Hospital (GB)
PFP Statistical Consulting LLC, Livonia, Michigan
Brown University (US)
ORCID: Sabbagh, Marwan N.
Beach, Thomas G.
Duara, Ranjan
Fleisher, Adam S.
Frey, Kirk A.
Walker, Zuzana
Holmes, Clive
Agronin, Marc E.
Ross, Joel
Bozoki, Andrea
Shi, Jiong
Vandenberghe, Rik
Sherwin, Paul F.
Smith, Adrian P. L.
Buckley, Christopher J.
Salloway, Stephen
Venue: JAMA Neurology
Publisher: American Medical Association (AMA)
Published: 2015-03-01
Volume: 72
Issue: 3
Pages: 287
ISSN: 2168-6149 (ISSN-L)
DOI: 10.1001/jamaneurol.2014.4144
OpenAlex: W2164443763
Cited by: 332
References: 30
Citations by year: 2026: 17 · 2025: 41 · 2024: 26 · 2023: 20 · 2022: 29 · 2021: 34 · 2020: 36 · 2019: 29 · 2018: 20 · 2017: 24 · 2016: 33 · 2015: 22
FWCI: 26.77
Type: journal article
Language: en
Open access: green
lirias.kuleuven.be
Licence: other-oa
Locations: JAMA Neurology (publishedVersion)
PubMed (publishedVersion)
Lirias (submittedVersion, other-oa)
ePrints Soton (University of Southampton) (submittedVersion)
UCL Discovery (University College London) (submittedVersion)
Topics: Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
Life Sciences › Neuroscience › Cellular and Molecular Neuroscience › Alzheimer's disease research and treatments
Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Medical Imaging Techniques and Applications
Keywords: Alzheimer's disease, sensitivity and specificity, dying patients, brain donation, dementia diagnosis
MeSH terms: Aged, Aged, 80 and over, Aniline Compounds, Female, Fluorine Radioisotopes, Humans, Male, Middle Aged, Single-Blind Method, Positron-Emission Tomography, Benzothiazoles, Plaque, Amyloid

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Phase 3 Trial of Flutemetamol Labeled With Radioactive Fluorine 18 Imaging and Neuritic Plaque Density

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