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Japanese and North American Alzheimer's Disease Neuroimaging Initiative studies: Harmonization for international trials.
Alzheimers Dement. 2018 08; 14(8):1077-1087.AD

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.

Links

Publisher Full Text (DOI)

Authors+Show Affiliations

Iwatsubo T
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.
Iwata A
Department of Neurology, The University of Tokyo Hospital, Tokyo, Japan.
Suzuki K
Unit for Early and Exploratory Clinical Development, The University of Tokyo Hospital, Tokyo, Japan.
Ihara R
Unit for Early and Exploratory Clinical Development, The University of Tokyo Hospital, Tokyo, Japan.
Arai H
Department of Geriatrics, Tohoku University, Sendai, Japan.
Ishii K
Research Team for Neuroimaging, Tokyo Metropolitan Institute of Gerontology, Tokyo, Japan.
Senda M
Division of Molecular Imaging, Institute of Biomedical Research and Innovation, Kobe, Japan.
Ito K
Department of Clinical and Experimental Neuroimaging, National Center for Geriatrics and Gerontology, Obu, Japan.
Ikeuchi T
Department of Molecular Genetics, Bioresource Science Branch, Center for Bioresources, Brain Research Institute, Niigata University, Niigata, Japan.
Kuwano R
Department of Molecular Genetics, Bioresource Science Branch, Center for Bioresources, Brain Research Institute, Niigata University, Niigata, Japan.
Matsuda H
Integrative Brain Imaging Center, National Center for Neurology and Psychiatry, Kodaira, Japan.
Japanese Alzheimer's Disease Neuroimaging Initiative
No affiliation info available
Sun CK
Alzheimer's Therapeutics Research Institute, University of Southern California, San Diego, CA, USA.
Beckett LA
Division of Biostatistics, Department of Public Health Sciences, University of California, Davis, Davis, CA, USA.
Petersen RC
Department of Neurology, Mayo Clinic, Rochester, MN, USA.
Weiner MW
Department of Veterans Affairs Medical Center, Center for Imaging of Neurodegenerative Diseases, University of California, San Francisco, CA, USA.
Aisen PS
Alzheimer's Therapeutics Research Institute, University of Southern California, San Diego, CA, USA.
Donohue MC
Alzheimer's Therapeutics Research Institute, University of Southern California, San Diego, CA, USA.
Alzheimer's Disease Neuroimaging Initiative
No affiliation info available

MeSH

AgedAlzheimer DiseaseAmyloid beta-PeptidesBrainCognition DisordersDisease ProgressionFemaleHumansInternationalityJapanMaleNeuroimagingNeuropsychological TestsPositron-Emission TomographyUnited States

Pub Type(s)

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

Language

eng

PubMed ID

29753531

Citation

Iwatsubo, Takeshi, et al. "Japanese and North American Alzheimer's Disease Neuroimaging Initiative Studies: Harmonization for International Trials." Alzheimer's & Dementia : the Journal of the Alzheimer's Association, vol. 14, no. 8, 2018, pp. 1077-1087.
Iwatsubo T, Iwata A, Suzuki K, et al. Japanese and North American Alzheimer's Disease Neuroimaging Initiative studies: Harmonization for international trials. Alzheimers Dement. 2018;14(8):1077-1087.
Iwatsubo, T., Iwata, A., Suzuki, K., Ihara, R., Arai, H., Ishii, K., Senda, M., Ito, K., Ikeuchi, T., Kuwano, R., Matsuda, H., Sun, C. K., Beckett, L. A., Petersen, R. C., Weiner, M. W., Aisen, P. S., & Donohue, M. C. (2018). Japanese and North American Alzheimer's Disease Neuroimaging Initiative studies: Harmonization for international trials. Alzheimer's & Dementia : the Journal of the Alzheimer's Association, 14(8), 1077-1087. https://doi.org/10.1016/j.jalz.2018.03.009
Iwatsubo T, et al. Japanese and North American Alzheimer's Disease Neuroimaging Initiative Studies: Harmonization for International Trials. Alzheimers Dement. 2018;14(8):1077-1087. PubMed PMID: 29753531.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Japanese and North American Alzheimer's Disease Neuroimaging Initiative studies: Harmonization for international trials. AU - Iwatsubo,Takeshi, AU - Iwata,Atsushi, AU - Suzuki,Kazushi, AU - Ihara,Ryoko, AU - Arai,Hiroyuki, AU - Ishii,Kenji, AU - Senda,Michio, AU - Ito,Kengo, AU - Ikeuchi,Takeshi, AU - Kuwano,Ryozo, AU - Matsuda,Hiroshi, AU - ,, AU - Sun,Chung-Kai, AU - Beckett,Laurel A, AU - Petersen,Ronald C, AU - Weiner,Michael W, AU - Aisen,Paul S, AU - Donohue,Michael C, AU - ,, Y1 - 2018/05/09/ PY - 2017/12/08/received PY - 2018/02/19/revised PY - 2018/03/01/accepted PY - 2018/5/14/pubmed PY - 2019/7/28/medline PY - 2018/5/14/entrez KW - ADNI KW - Alzheimer's disease KW - Amyloid PET imaging KW - Biomarker KW - Harmonization KW - Japan KW - Mild cognitive impairment SP - 1077 EP - 1087 JF - Alzheimer's & dementia : the journal of the Alzheimer's Association JO - Alzheimers Dement VL - 14 IS - 8 N2 - 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. SN - 1552-5279 UR - https://www.unboundmedicine.com/medline/citation/29753531/Japanese_and_North_American_Alzheimer's_Disease_Neuroimaging_Initiative_studies:_Harmonization_for_international_trials_ DB - PRIME DP - Unbound Medicine ER -