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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
Osaka City Univ Hosp, Dept Geriatr, Abeno Ku, 5-7 Asahi Machi 1 Chome, Osaka, Japan.;Izumiotsu Municipal Hosp, Shimojyo Chou 16-1, Izumiotsu, Osaka 5950027, Japan..
Osaka City Univ Hosp, Dept Geriatr, Abeno Ku, 5-7 Asahi Machi 1 Chome, Osaka, Japan..
Asan Med Ctr, Dept Nucl Med, 388-1 Pungnap 2 Dong, Seoul, South Korea..
Kobe Univ Hosp, Neuropsychiat Dept, Chuo Ku, 5-2 Kusunoki Cho 7 Chome, Kobe, Hyogo, Japan..
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2017 (English)In: Annals of Nuclear Medicine, ISSN 0914-7187, E-ISSN 1864-6433, Vol. 31, no 3, 260-272 p.Article in journal (Refereed) Published
Abstract [en]

Objective This Phase 2 study assessed the performance of positron emission tomography (PET) brain images made with Flutemetamol F 18 Injection in detecting beta-amyloid neuritic plaques in Japanese subjects. Methods Seventy 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. Results PPA 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 ae<yen>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. Conclusion The detection of brain neuritic plaques in Japanese subjects using [F-18]Flutemetamol PET images gave results highly consistent with clinical diagnosis, with non-Japanese and Japanese readers giving similar results. Inter-reader agreement and intra-reader reproducibility were high for both sets of readers. Visual delineation of abnormal and normal scans was corroborated by quantitative assessment, with low test-retest variability.

Place, publisher, year, edition, pages
2017. Vol. 31, no 3, 260-272 p.
Keyword [en]
[F-18] Flutemetamol, Alzheimer's disease, Radiotracer, beta-Amyloid
National Category
Radiology, Nuclear Medicine and Medical Imaging
Identifiers
URN: urn:nbn:se:uu:diva-321328DOI: 10.1007/s12149-017-1154-7ISI: 000398448400008PubMedID: 28181118OAI: oai:DiVA.org:uu-321328DiVA: diva2:1104020
Available from: 2017-05-31 Created: 2017-05-31 Last updated: 2017-05-31Bibliographically approved

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