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Japanese and North American Alzheimer's Disease Neuroimaging Initiative studies: Harmonization for international trials
Authors:Takeshi Iwatsubo  Atsushi Iwata  Kazushi Suzuki  Ryoko Ihara  Hiroyuki Arai  Kenji Ishii  Michio Senda  Kengo Ito  Takeshi Ikeuchi  Ryozo Kuwano  Hiroshi Matsuda  Chung-Kai Sun  Laurel A Beckett  Ronald C Petersen  Michael W Weiner  Paul S Aisen  Michael C Donohue
Institution:1. Unit for Early and Exploratory Clinical Development, The University of Tokyo Hospital, Tokyo, Japan;2. Department of Neuropathology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan;3. Department of Neurology, 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;g. Department of Clinical and Experimental Neuroimaging, National Center for Geriatrics and Gerontology, Obu, Japan;h. Department of Molecular Genetics, Bioresource Science Branch, Center for Bioresources, Brain Research Institute, Niigata University, Niigata, Japan;i. Integrative Brain Imaging Center, National Center for Neurology and Psychiatry, Kodaira, Japan;j. Alzheimer’s Therapeutics Research Institute, University of Southern California, San Diego, CA, USA;k. Division of Biostatistics, Department of Public Health Sciences, University of California, Davis, Davis, CA, USA;l. Department of Neurology, Mayo Clinic, Rochester, MN, USA;m. Department of Veterans Affairs Medical Center, Center for Imaging of Neurodegenerative Diseases, University of California, San Francisco, CA, USA
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:Alzheimer's disease  ADNI  Mild cognitive impairment  Biomarker  Amyloid PET imaging  Harmonization  Japanese Alzheimer's Disease Neuroimaging Initiative
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