Japanese and North American Alzheimer's Disease Neuroimaging Initiative studies: Harmonization for international trials

Takeshi Iwatsubo; Atsushi Iwata; Kazushi Suzuki; Ryoko Ihara; Hiroyuki Arai; Kenji Ishii; Michio Senda; Kengo Ito; Takeshi Ikeuchi; Ryozo Kuwano; Hiroshi Matsuda; Japanese Alzheimer's Disease Neuroimaging Initiative; Chung-Kai Sun; Laurel A Beckett; Ronald C Petersen; Michael W Weiner; Paul S Aisen; Michael C Donohue; Alzheimer's Disease Neuroimaging Initiative

doi:10.1016/j.jalz.2018.03.009

Japanese and North American Alzheimer's Disease Neuroimaging Initiative studies: Harmonization for international trials

Alzheimers Dement. 2018 Aug;14(8):1077-1087. doi: 10.1016/j.jalz.2018.03.009. Epub 2018 May 9.

Authors

Takeshi Iwatsubo¹, Atsushi Iwata², Kazushi Suzuki³, Ryoko Ihara³, Hiroyuki Arai⁴, Kenji Ishii⁵, Michio Senda⁶, Kengo Ito⁷, Takeshi Ikeuchi⁸, Ryozo Kuwano⁸, Hiroshi Matsuda⁹; Japanese Alzheimer's Disease Neuroimaging Initiative; Chung-Kai Sun¹⁰, Laurel A Beckett¹¹, Ronald C Petersen¹², Michael W Weiner¹³, Paul S Aisen¹⁰, Michael C Donohue¹⁰; Alzheimer's Disease Neuroimaging Initiative

Affiliations

¹ Unit for Early and Exploratory Clinical Development, The University of Tokyo Hospital, Tokyo, Japan; Department of Neuropathology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan. Electronic address: iwatsubo@m.u-tokyo.ac.jp.
² Department of Neurology, The University of Tokyo Hospital, Tokyo, Japan.
³ Unit for Early and Exploratory Clinical Development, The University of Tokyo Hospital, Tokyo, Japan.
⁴ Department of Geriatrics, Tohoku University, Sendai, Japan.
⁵ Research Team for Neuroimaging, Tokyo Metropolitan Institute of Gerontology, Tokyo, Japan.
⁶ Division of Molecular Imaging, Institute of Biomedical Research and Innovation, Kobe, Japan.
⁷ Department of Clinical and Experimental Neuroimaging, National Center for Geriatrics and Gerontology, Obu, Japan.
⁸ Department of Molecular Genetics, Bioresource Science Branch, Center for Bioresources, Brain Research Institute, Niigata University, Niigata, Japan.
⁹ Integrative Brain Imaging Center, National Center for Neurology and Psychiatry, Kodaira, Japan.
¹⁰ Alzheimer's Therapeutics Research Institute, University of Southern California, San Diego, CA, USA.
¹¹ Division of Biostatistics, Department of Public Health Sciences, University of California, Davis, Davis, CA, USA.
¹² Department of Neurology, Mayo Clinic, Rochester, MN, USA.
¹³ Department of Veterans Affairs Medical Center, Center for Imaging of Neurodegenerative Diseases, University of California, San Francisco, CA, USA.

PMID: 29753531
DOI: 10.1016/j.jalz.2018.03.009

Abstract

Introduction: We conducted Japanese Alzheimer's Disease Neuroimaging Initiative (J-ADNI) and compared the basic characteristics and progression profiles with those of ADNI in North America.

Methods: A total of 537 Japanese subjects with normal cognition, late amnestic mild cognitive impairment (LMCI), or mild Alzheimer's disease (AD) were enrolled using the same criteria as ADNI. Rates of changes in representative cognitive or functional measures were compared for amyloid positron emission tomography- or cerebrospinal fluid amyloid β(1-42)-positive LMCI and mild AD between J-ADNI and ADNI.

Results: Amyloid positivity rates were significantly higher in normal cognition of ADNI but at similar levels in LMCI and mild AD between J-ADNI and ADNI. Profiles of decline in cognitive or functional measures in amyloid-positive LMCI in J-ADNI (n = 75) and ADNI (n = 269) were remarkably similar, whereas those in mild AD were milder in J-ADNI (n = 73) compared with ADNI (n = 230).

Discussion: These results support the feasibility of bridging of clinical trials in the prodromal stage of AD between Asia and western countries.

Keywords: ADNI; Alzheimer's disease; Amyloid PET imaging; Biomarker; Harmonization; Japan; Mild cognitive impairment.

Publication types

Research Support, N.I.H., Extramural
Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

Aged
Alzheimer Disease / cerebrospinal fluid
Alzheimer Disease / diagnostic imaging*
Amyloid beta-Peptides
Brain / diagnostic imaging
Cognition Disorders / cerebrospinal fluid
Cognition Disorders / diagnostic imaging*
Disease Progression
Female
Humans
Internationality*
Japan
Male
Neuroimaging / methods*
Neuropsychological Tests / statistics & numerical data
Positron-Emission Tomography / methods
United States

Substances

Amyloid beta-Peptides