Phase 3 Trial of Flutemetamol Labeled With Radioactive Fluorine 18 Imaging and Neuritic Plaque Density
Open accessAbstract
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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These and other studies strongly support the concept of AD as an amyloid-provoked or facilitated tauopathy, although there is also evidence that both pathologies act in synergy.
“These and other studies 13,24,133,134 strongly support the concept of AD as being an amyloid-provoked, or facilitated, tauopathy, although there is also evidence that both pathologies act in synergy 135 .”
From The amyloid hypothesis in Alzheimer disease: new insights from new therapeutics (2022) · cites this paper as [134]
Positron emission tomography ligands have been shown to provide a minimally invasive estimate of the neuropathological features of Alzheimer disease, such as amyloid-β neuritic plaque deposition.
“Positron emission tomography (PET) ligands have been shown to provide a minimally invasive estimate of the neuropathological features of AD, such as Aβ neuritic plaque deposition.15,16,17,18”
From Positron Emission Tomography Imaging With [ <sup>18</sup> F]flortaucipir and Postmortem Assessment of Alzheimer Disease Neuropathologic Changes (2020) · cites this paper as [17]
Large autopsy studies have demonstrated a high sensitivity and specificity for amyloid positron emission tomography to distinguish individuals with subsequent autopsy findings of no or sparse neuritic plaque from individuals with moderate to frequent plaque.
“For example, large autopsy studies have demonstrated a high sensitivity and specificity for amyloid PET to distinguish individuals with subsequent autopsy findings of no or sparse neuritic plaque from individuals with moderate to frequent plaque.16,17,18”
From Positron Emission Tomography Imaging With [ <sup>18</sup> F]flortaucipir and Postmortem Assessment of Alzheimer Disease Neuropathologic Changes (2020) · cites this paper as [17]
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Self-citation
- 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
- Venue
- JAMA Neurology
- Publisher
- American Medical Association (AMA)
- Published
- 2015-03-01
- Volume
- 72
- Issue
- 3
- Pages
- 287
- ISSN
- 2168-6149 (ISSN-L)
- 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 · 2014: 1
- 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
- Health Sciences › Medicine › Physiology › 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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