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Imaging characteristics and safety of florbetapir (¹⁸F) in Japanese healthy volunteers, patients with mild cognitive impairment and patients with Alzheimer's disease.
Ann Nucl Med 2015; 29(7):570-81AN

Abstract

OBJECTIVE

The purpose of this study was to evaluate the performance characteristics and safety of florbetapir ((I8)F) positron emission tomography (PET) in patients with Alzheimer's disease (AD) and mild cognitive impairment (MCI) and cognitively normal (CN) control patients from Japan.

METHODS

Florbetapir ((I8)F) PET was obtained in 48 subjects (15 AD patients, 15 MCI patients, and 18 CNs) within a multicenter phase 2/3 study. Amyloid burden was assessed visually and classified as positive or negative for pathologic levels of amyloid aggregation, blind to diagnostic classification. Cerebral to cerebellar standardized uptake value ratios (SUVRs) were determined from the florbetapir ((I8)F) PET images. Safety was assessed by monitoring adverse events, vital signs, clinical laboratory assessments, and electrocardiograms. Demographic variables and cognitive scales were summarized by using descriptive statistics for each group. Fisher's exact test and one-way analysis of variance were used to compare amyloid positivity and mean SUVRs, respectively, between diagnostic groups.

RESULTS

Florbetapir ((I8)F) PET was rated visually amyloid positive in 80.0% of AD patients, 33.3% of MCI patients, and 16.7% of CNs. Mean SUVRs were highest in the AD group and lowest in the CN group for each brain region (P < 0.01) and globally (P < 0.05). Kappa statistics showed strong inter-reader agreement (Fleiss' kappa = 0.82) and individual reader's agreement with the majority of readers (kappa ranged from 0.79 to 1.0). Seventeen of the 48 subjects (35.4%) were Apolipoprotein E genotype ε4 positive, which included 10 subjects in the AD group and 7 subjects in the MCI group. A total of 6 subjects (5 of whom were in the CN group) had at least 1 treatment-emergent adverse event (TEAE).

CONCLUSIONS

These data indicate that amyloid positivity increased with diagnostic category (CN < MCI < AD) and are consistent with expected rates of amyloid positivity among individuals with clinical diagnoses of AD and MCI. In addition, these results were similar to those obtained in United States studies. Florbetapir ((18)F) was safe and well tolerated. The reliability of both qualitative and quantitative assessments of florbetapir ((18)F) in this study population provides support for potential use in clinical settings in Japan.

Authors+Show Affiliations

Department of Psychiatry, Kyoto University Hospital, 54 Kawaharacho, Syogoin, Sakyu-ku, Kyoto, 606-8507, Japan, cnamiki@kuhp.kyoto-u.ac.jp.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25943346

Citation

Namiki, Chihiro, et al. "Imaging Characteristics and Safety of Florbetapir (¹⁸F) in Japanese Healthy Volunteers, Patients With Mild Cognitive Impairment and Patients With Alzheimer's Disease." Annals of Nuclear Medicine, vol. 29, no. 7, 2015, pp. 570-81.
Namiki C, Takita Y, Iwata A, et al. Imaging characteristics and safety of florbetapir (¹⁸F) in Japanese healthy volunteers, patients with mild cognitive impairment and patients with Alzheimer's disease. Ann Nucl Med. 2015;29(7):570-81.
Namiki, C., Takita, Y., Iwata, A., Momose, T., Senda, M., Okubo, Y., ... Pontecorvo, M. J. (2015). Imaging characteristics and safety of florbetapir (¹⁸F) in Japanese healthy volunteers, patients with mild cognitive impairment and patients with Alzheimer's disease. Annals of Nuclear Medicine, 29(7), pp. 570-81. doi:10.1007/s12149-015-0978-2.
Namiki C, et al. Imaging Characteristics and Safety of Florbetapir (¹⁸F) in Japanese Healthy Volunteers, Patients With Mild Cognitive Impairment and Patients With Alzheimer's Disease. Ann Nucl Med. 2015;29(7):570-81. PubMed PMID: 25943346.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Imaging characteristics and safety of florbetapir (¹⁸F) in Japanese healthy volunteers, patients with mild cognitive impairment and patients with Alzheimer's disease. AU - Namiki,Chihiro, AU - Takita,Yasushi, AU - Iwata,Atsushi, AU - Momose,Toshimitsu, AU - Senda,Michio, AU - Okubo,Yoshiro, AU - Joshi,Abhinay D, AU - Lu,Ming, AU - Agbulos,Abigail, AU - Breault,Christopher, AU - Pontecorvo,Michael J, Y1 - 2015/05/06/ PY - 2014/11/29/received PY - 2015/04/22/accepted PY - 2015/5/7/entrez PY - 2015/5/7/pubmed PY - 2016/5/6/medline SP - 570 EP - 81 JF - Annals of nuclear medicine JO - Ann Nucl Med VL - 29 IS - 7 N2 - OBJECTIVE: The purpose of this study was to evaluate the performance characteristics and safety of florbetapir ((I8)F) positron emission tomography (PET) in patients with Alzheimer's disease (AD) and mild cognitive impairment (MCI) and cognitively normal (CN) control patients from Japan. METHODS: Florbetapir ((I8)F) PET was obtained in 48 subjects (15 AD patients, 15 MCI patients, and 18 CNs) within a multicenter phase 2/3 study. Amyloid burden was assessed visually and classified as positive or negative for pathologic levels of amyloid aggregation, blind to diagnostic classification. Cerebral to cerebellar standardized uptake value ratios (SUVRs) were determined from the florbetapir ((I8)F) PET images. Safety was assessed by monitoring adverse events, vital signs, clinical laboratory assessments, and electrocardiograms. Demographic variables and cognitive scales were summarized by using descriptive statistics for each group. Fisher's exact test and one-way analysis of variance were used to compare amyloid positivity and mean SUVRs, respectively, between diagnostic groups. RESULTS: Florbetapir ((I8)F) PET was rated visually amyloid positive in 80.0% of AD patients, 33.3% of MCI patients, and 16.7% of CNs. Mean SUVRs were highest in the AD group and lowest in the CN group for each brain region (P < 0.01) and globally (P < 0.05). Kappa statistics showed strong inter-reader agreement (Fleiss' kappa = 0.82) and individual reader's agreement with the majority of readers (kappa ranged from 0.79 to 1.0). Seventeen of the 48 subjects (35.4%) were Apolipoprotein E genotype ε4 positive, which included 10 subjects in the AD group and 7 subjects in the MCI group. A total of 6 subjects (5 of whom were in the CN group) had at least 1 treatment-emergent adverse event (TEAE). CONCLUSIONS: These data indicate that amyloid positivity increased with diagnostic category (CN < MCI < AD) and are consistent with expected rates of amyloid positivity among individuals with clinical diagnoses of AD and MCI. In addition, these results were similar to those obtained in United States studies. Florbetapir ((18)F) was safe and well tolerated. The reliability of both qualitative and quantitative assessments of florbetapir ((18)F) in this study population provides support for potential use in clinical settings in Japan. SN - 1864-6433 UR - https://www.unboundmedicine.com/medline/citation/25943346/Imaging_characteristics_and_safety_of_florbetapir__¹⁸F__in_Japanese_healthy_volunteers_patients_with_mild_cognitive_impairment_and_patients_with_Alzheimer's_disease_ L2 - https://dx.doi.org/10.1007/s12149-015-0978-2 DB - PRIME DP - Unbound Medicine ER -