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” Research project for the development of a systematic method for
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| Participating firms | Astellas Pharma, Eisai Co., Sanko Junyaku Co., GE Yokogawa Medical Systems, Shionogi & Co., Siemens-Asahi Medical Technologies, Shimadzu Co., Daiichi Sankyo Co., Ltd., Dainippon Sumitomo Pharma Co., Ltd., Takeda Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma Co., Toshiba Medical Systems, Eli Lilly Japan, Nihon Medi-Physics Co., Banyu Pharmaceutical Co., Hitachi Medical Corp., Pfizer Japan, Precision System Science Co., Micron Inc. Immuno-Biological Laboratories Co., Ltd, Yamatake Corporation, Yokogawa Electric Corporation. |
| Joint Research | National Center of Neurology and Psychiatry, National Institute for Longevity Sciences, Saitama Medical University, Foundation for Biomedical Research and Innovation, University of Tsukuba, University of Tokyo, Tokyo Metropolitan Institute of Gerontology, Tohoku University, Doshinsha University, Niigata University, and other institutions for a total of 33 clinical research facilities nationwide |
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| Research Objectives | |
| This research seeks to promptly create a treatment for AD (Alzheimerfs
disease) and accelerate trials with that treatment by standardizing objective
indicators of the onset of AD with a focus on diagnostic imaging. Using
the results provided by MEXTfs Advanced Brain Science Project, this research
also seeks to validate humoral biomarkers (biochemical markers) and accelerate
their practical use and to achieve a comprehensive diagnostic system for
AD that fuses diagnostic imaging and biochemistry. |
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| Research content | |
| R & D item @ Research to standardize clinical assessment of AD (J-ADNI clinical research) |
| Image data, clinical data, and biochemical data (bodily fluids) will be
collected from the elderly for 3 years at intervals of every half a year
or year in 3 stages: health, mild cognitive impairment (MCI) - believed
to be the state preceding AD, and (mild) AD. These data will then be crafted
into a database. This research will standardize diagnostic imaging and
objective indicators for the onset of AD by following subjects over those
3 years and analyzing changes in images reflecting development from MCI
to AD (measurement of brain volume using MRI, glucose metabolism using
PET, and Ą-amyloid imaging). Acquisition of imaging data will be done through
coordination of 4 hubs wordwide - Japan, the US, Europe, and Australia
? so images will be acquired in accordance with the protocol of the US-ADNI. |
| R & D item A Research to construct a database and develop analytical software with J-ADNI |
| A database of neuroimaging data (from a total of 35 clinical facilities nationwide) acquired in R & D item @, Research to standardize clinical assessment of AD (J-ADNI clinical research), will be constructed. New neuroimaging analysis software will also be developed to precisely depict changes at 2 or more times using new techniques for statistical analysis of images based on neuroimaging data collected and managed over time. |
| R & D item B Development of technology related to diagnostic markers for AD and MCI |
| Biological specimens will be collected, stored, and managed, APOE genotyping,
AĄ and tau testing, and general biochemistries will be performed, and gene
expression analysis reflecting the progression of pathological changes
in autopsied brains that were normal and that had AD will be performed.
Highly sensitive and precise original biomarkers will be identified, and
whether these biomarkers are suited to monitoring the state of the disease
in cerebrospinal fluid or peripheral blood will be verified. While such
research is implemented, technology related to diagnostic markers for AD
and MCI will be developed. |
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