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.

Fig. 1. Biomarker changes in Alzheimer’s disease up to the onset of dementia.

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).

Fig. 2. Comparison of APP gencDNA (intramolecular recombinant amyloid precursor protein gene) transcripts amounts in plasma between the Alzheimer’s disease group (SAD) and non-demented individuals (NCI).

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).

Fig. 3. Reduction in the development of dementia by early diagnosis and initiation of treatment.

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.