ArticleAnnals of nuclear medicine2017
Brain uptake and safety of Flutemetamol F 18 injection in Japanese subjects with probable Alzheimer's disease, subjects with amnestic mild cognitive impairment and healthy volunteers.
Article in Annals of nuclear medicine, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02813070 (An Open-label Study to Assess Brain Uptake and Safety of Flutemetamol F 18 Injection in Japanese Subjects With Probable Alzheimer's Disease, Subjects With Amnestic Mild Cognitive Impairment and Healthy Volunteers), which is not on this map. Cited by 12 papers.
What it found
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
An Open-label Study to Assess Brain Uptake and Safety of Flutemetamol F 18 Injection in Japanese Subjects With Probable Alzheimer's Disease, Subjects With Amnestic Mild Cognitive Impairment and Healthy Volunteers
Who cites it
12 citing papers in PubMed.
- The Dementias Platform UK PET/MR harmonisation and test-retest study: assessment of PET repeatability and reproducibility across the national network.European journal of nuclear medicine and molecular imaging · 2026Article
- Comparability of Centiloid values from [Neuroimage. Reports · 2026Article
- Fueling the brain - the role of apolipoprotein E in brain energy metabolism and its implications for Alzheimer's disease.Translational psychiatry · 2025Review
- Considerations in the clinical use of amyloid PET and CSF biomarkers for Alzheimer's disease.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2025Review
- Relationship between F-18 florbetapir uptake in occipital lobe and neurocognitive performance in Alzheimer's disease.Japanese journal of radiology · 2021Article
- Initial Physician Experience with [Journal of Alzheimer's disease reports · 2020Article
- Temporal and anatomical distribution ofBMC veterinary research · 2020Article
- The Who, When, Why, and How of PET Amyloid Imaging in Management of Alzheimer's Disease-Review of Literature and Interesting Images.Diagnostics (Basel, Switzerland) · 2019Review
- Clinical and Biomarker Characteristics According to Clinical Spectrum of Alzheimer's Disease (AD) in the Validation Cohort of Korean Brain Aging Study for the Early Diagnosis and Prediction of AD.Journal of clinical medicine · 2019Article
- Centiloid scaling for quantification of brain amyloid with [EJNMMI research · 2018Article
- Performance of [Alzheimer's & dementia (Amsterdam, Netherlands) · 2017Article
- Long-term Changes in 18F-Flutemetamol Uptake in Nondemented Older Adults.Alzheimer disease and associated disordersArticle
Corrections and comments
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Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveThis Phase 2 study assessed the performance of positron emission tomography (PET) brain images made with Flutemetamol F 18 Injection in detecting β-amyloid neuritic plaques in Japanese subjects.
methodsSeventy subjects (25 with probable Alzheimer's disease (pAD), 20 with amnestic mild cognitive impairment (aMCI), and 25 cognitively normal healthy volunteers[HVs]) underwent PET brain imaging after intravenous Flutemetamol F 18 Injection (185 MBq). Images were interpreted as normal or abnormal for neuritic plaque density by each of five non-Japanese and five Japanese readers who were blinded to clinical data. The primary efficacy analysis (based on HV and pAD data) was the agreement of the non-Japanese readers' image interpretations with the clinical diagnosis, resulting in estimates of positive percent agreement (PPA; based on AD subjects; similar to sensitivity) and negative percent agreement (NPA; based on HVs; similar to specificity). Secondary analyses included PPA and NPA for the Japanese readers; inter-reader agreement (IRA); intra-reader reproducibility (IRR); quantitative image interpretations (standardized uptake value ratios [SUVRs]) by diagnostic subgroup; test-retest variability in five pAD subjects; and safety.
resultsPPA was 92% for all non-Japanese readers and ranged from 88 to 92% for the Japanese readers. NPA ranged from 96 to 100% for both the non-Japanese readers and the Japanese readers. The majority image interpretations (the interpretations made independently by ≥3 of 5 readers) resulted in PPA values of 92 and 92% and NPA values of 100 and 96% for the non-Japanese and Japanese readers, respectively. IRA and IRR were strong. Composite SUVR values (mean of multiple regional values) allowed clear differentiation between pAD subjects and HVs. Test-retest variability ranged from 1.14 to 2.27%, and test-retest agreement of the blinded visual interpretations was 100% for all readers. Flutemetamol F 18 Injection was generally well tolerated.
conclusionsThe detection of brain neuritic plaques in Japanese subjects using [
trial registrationClinicaltrials.gov registration number NCT02813070.
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