Technology|Publications & Patents


Our technology for the early diagnosis of Alzheimer’s disease

Alzheimer’s disease is the leading cause of dementia. The development of Alzheimer’s disease involves the accumulation of amyloid-β in the brain, where the accumulated amyloid-β causes abnormal phosphorylation of tau protein and neurofibrillary change formation. These accumulations and changes cause neuronal damage, resulting in the destruction of nerve cells and the onset of dementia.

Amyloid-β accumulation starts about 20 years before the onset of dementia, after which neuronal damage begins, but cognitive function is normal for a long period of time. Early diagnosis of Alzheimer’s disease is therefore difficult, and by the time mild cognitive impairment or dementia is diagnosed, irreversible neuronal damage is well advanced (Fig. 1). Therefore, even if treatment is initiated at the stage of mild cognitive impairment or early dementia, the therapeutic effect will not be very high.

We believe that earlier diagnosis and initiation of treatment would be more effective and improve patients’ quality of life. For this early diagnosis, we need an inexpensive method that a simple blood test can diagnose. APP gencDNA is an intramolecular recombination of the amyloid precursor protein from which amyloid-β is derived and is neuron-specific. When transcripts of APP gencDNA in blood were compared between SAD (Alzheimer’s disease) and NCI (normal cognitive function), there was a significant difference with a P-value of 5.14 x 10-6 (Fig. 2).

We believe that early diagnosis using the transcripts of APP gencDNA in the blood as a biomarker and early initiation of treatment would reduce cognitive decline and improve patients’ quality of life (Fig. 3).

Literature: Shigeki Mitsunaga, Naoko Fujito, Hirofumi Nakaoka, Ryoko Imazeki, Eiichiro Nagata, Ituro Inoue. detection of APP gene recombinant in human

blood. Scientific Reports 13(1): 21703, 2023.
Patent application: PCT/JP2022/041683.


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Ituro Inoue's career

He graduated from the Faculty of Medicine, Kagoshima University, and the Graduate Course, Department of Biochemistry, Faculty of Medicine, Kagoshima University, and was awarded a Ph.D. in Biochemistry. He was a Research Associate, at the Department of Human Genetics, University of Utah, Associate Professor at the Institute for Molecular and Cellular Regulation at Gunma University, Associate Professor at the Institute of Medical Science, University of Tokyo, Professor at the School of Medicine, University of Tokai, Director, Institute of Medical Sciences, University of Tokai, and Professor, National Institute of Genetics, and is currently Honorary Professor, National Institute of Genetics, Visiting Professor, Keio University, and Visiting Researcher, Sasaki Institute.

Shigeki Mitsunaga's career

He graduated from the Faculty of Science, Tokyo Metropolitan University, after working in the Research Department of the Central Blood Centre of the Japanese Red Cross, the Viral Oncology Department of the Cancer Institute, the Genome Business Development Division of Olympus, Tokai University as a Research Professor, three bio ventures, a JICA senior overseas volunteer in Vietnam, and a Research Fellow at the National Institute of Genetics, currently, he is a Co-Investigator at Keio University and a Visiting Researcher at the Sasaki Institute.

Naoko Fujito's career

Naoko Fujito is currently serving as an Assistant Professor at the National Institute of Genetics in Japan. She completed her undergraduate studies at Ochanomizu University and earned her Ph.D. from the School of Science at the University of Tokyo. Following her doctoral studies, Naoko worked as a Postdoctoral Fellow at SOKENDAI and later as an Associate Specialist at the University of California, San Francisco. She also gained valuable experience as a Postdoctoral Research Fellow at San Francisco State University.

Naoko has been actively working on evolutionary aspects of disease-related genes in humans since joining the National Institute of Genetics in October 2020.


お茶の水女子大学、東京大学大学院卒、博士(理学)。東大 博士研究員、総研大 特別研究員、UCSF Associate Specialist、SFSU Postdoctoral research fellowを経て、国立遺伝学研究所 特任助教。


都立大学理学部卒、博士(理学)。日赤中央血液センター研究部、癌研ウイルス腫瘍部、オリンパスゲノム事業開発推進室、東海大学 特任教授、3つのバイオベンチャー、JICAシニア海外ボランティア、国立遺伝学研究所 特任研究員等を経て、慶応大学 共同研究員、佐々木研究所 客員研究員。


鹿児島大学医学部、同大学院博士課程卒、医師、医学博士。ユタ大学研究員、群馬大学助教授、東大・医科研 客員助教授、東海大学 教授、国立遺伝学研究所 教授を経て、同名誉教授、慶応大学 客員教授、佐々木研究所 客員研究員。