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Orange Registry



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In Japan, dementia prevalence in 2014 was about 4.6million people (about 15% of people aged 65 and over) and Mild Cognitive Impairment (MCI) was estimated to be about 4 million in the same year. Based on Hisayama cohort study (since 1985), the number of people with dementia is estimated to be over 9 million in near future when diabetic disease is not controlled. This is an alarming situation. On a global basis, prevalence rate of dementia is about 8% and the number of people with dementia is estimated to reach 35 million in near future. Dementia is now becoming a global challenge as well.

Despite this serious situation, development of disease-modifying drugs for dementia has not been making much progress for the last 10 years. Although the development of pre-emptive medicine is the mainstream of current R&D, such medicine to prevent dementia before its onset does not seem likely to be available in next five to ten years. This means that there is no therapeutic prevention for baby-boomer generations when they turn older than 75 years which is the age dementia prevalence increase. 

Before disease-modifying drugs for dementia will be ready in the future, we need to increase the cognitive reserve, and to conduct trials and prepare environment to raise the threshold and delay the dementia onset.  Several observational studies and RCT have proven that the length of education and exercise to be strong factors to suppress decline of cognitive function. Other potential benefitting factors are Mediterranean diet, cognitive training, and moderate drinking.

For the studies with clinical end-point set to dementia onset, more than ten years of follow-up is required when subjects are in pre-clinical stage, and it would take several years even with the subjects in the MCI stage. However, the current study design is merely tracking the "change in cognitive function". In order to overcome this limitation, we needed to design long term follow-up period for dementia study, and develop registration and coordination system with novel ideas.   

The ORANGE Registry was established conforming to The New Orange Plan formulated in January 2015. The ORANGE Registry is the registration system that covers each stage of dementia,  enables us to follow-up on registered individuals, and allows us to understand the progress of the disease, as well as the clinical and living situation of each individual. This registry system enables us to find challenges and accumulate solutions conforming to some of the seven pillars of the New Orange Plan that are “the provision of timely and appropriate medical and nursing care in accordance with the condition of dementia", "support for family members," and "research, development and implementation of prophylaxis, diagnostics, treatment, rehabilitation model, and care model for dementia.

The ORANGE Registry is also able to track registered individual of the pre-clinical stage and MCI conforming to the intent of “Japan Revival Strategy 2015 revision,” and is able to respond to the requests from the industry sector.

The National Center for Geriatrics and Gerontology is honored to be the secretariat of the ORANGE Registry. In order to maintain continuous enrollment of subjects and promote the use by academia and industry sector, it is essential to obtain assistance from multiple fields.

We appreciate your support and guidance.

                                                                                                 Principal Investigator  Kenji Toba, MD, PhD
                                                                                                (President, National Center for Geriatrics and Gerontology)