******** The full report published October 22, 2021.
For more information, please refer to the PDF.

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Recognizing dementia as a global health policy issue, Health and Global Policy Institute (HGPI) has made continuous efforts in its capacity as a non-profit, independent health policy think tank to promote policy responses to dementia-related issues. Based on the pillars of building a global platform to advance multi-stakeholder collaboration in dementia policy promotion, emphasizing the perspectives of those most affected, and identifying and disseminating policy issues, HGPI is advancing efforts while strengthening partnerships with various stakeholders.

In 2012, it was estimated that there were 4.62 million people living with dementia in Japan. This figure accounted for 15% of the elderly population. In projections for 2025, their numbers are expected to grow to 7 million people or 20% of the elderly population. The National Framework for Promotion of Dementia Policies formulated in June 2019 includes measures for research on dementia onset and progression, the development of treatments, and the establishment of an infrastructure that can serve as the basis for promoting research and development. Along with the creation of a dementia-inclusive society, research and development of disease modifying therapies (DMTs) for dementia and the establishment of systems for their widespread use are urgent issues for Japan, where population aging is advancing.

For Alzheimer’s disease (AD), the cause of approximately 60% of all cases of dementia, it has been reported that recruiting subjects for clinical trials takes two to ten times longer than the trials themselves. This may be considered a major hurdle for R&D. To address issues like this, the Japanese Trial Ready Cohort (J-TRC), which began operating in October 2019, monitors cognitive function among people without dementia and serves as a platform to connect researchers with people who can participate in clinical trials for pharmaceuticals for AD prevention. In the future, it will be necessary to further improve this system by implementing best practices from other fields, such as by using patient-researcher collaboration to develop cohorts like in the field of oncology. As of March 2021, 28 clinical trials for AD pharmaceuticals are underway in Japan and around the world and one pharmaceutical is under review for approval in the U.S., Japan, and other countries. Expectations for the launch of the world’s first pharmaceutical for dementia are high. However, these new pharmaceuticals are likely to be expensive and will be used by an extremely large number of people, meaning that providing them with health insurance coverage will pose major challenges for healthcare financing. It will also be necessary to create a screening system for new pharmaceuticals that will examine them according to clinical applicability standards. In particular, it will be essential that the system is expanded so it can detect target biomarkers and provide early diagnoses when screening people in the very early stages of dementia. There is much anticipation regarding the use of digital technology in these areas. In addition to establishing and promoting a better environment for R&D, it will also be necessary to examine how to promote the clinical use of new DMTs that are likely to be launched in the near future.

From these perspectives, HGPI’s Dementia Policy Project held the Expert Kick-off Meeting “Issues and Prospects for Developing and Disseminating Disease Modifying Therapies for Dementia” and discussed issues related to R&D for DMTs in the field of dementia and identify challenges facing their clinical dissemination through discussions with industry, Government, academia, and civil society. We also considered what future measures must be taken from a multi-stakeholder perspective.

＜Future Discussion Points for Research and Development in the Field of Dementia＞

• Promoting an inclusive society to maximize benefits from R&D results
  If there are people who cannot receive a diagnosis and treatment for dementia at the right time due to prejudice and discrimination toward dementia, even if disease-modifying therapies (DMTs) for dementia are successfully developed, it will be impossible for those DMTs to reach the people who truly need them. The same applies to efforts to involve people with dementia, their families, and their caregivers in R&D. We can even say it will truly only be possible to promote participation form people with dementia in R&D when discrimination and prejudice have been eliminated. To achieve that, Japan is currently advancing measures under the National Framework for Promotion of Dementia Policies based on the two pillars of “inclusion” and “prevention.” However, to maximize R&D results, it will be essential to first build a society in which people coexist with dementia.

 

• Creating R&D designs that are centered on people living with dementia and adopting communication strategies to promote understanding toward research
  Rather than focusing only on medical effectiveness, it will be necessary to promote research that takes the perspectives of people living with dementia into account and will contribute to ease of living and better QOL. An example of one such initiative is underway in the U.K., where there is a system to promote research deemed high priority by people with dementia. This is done by involving them, their families, and their caregivers in research design, even for clinical studies. While referring to best practices from other countries and fields, it will be necessary to discuss how to best promote involvement from people with dementia in R&D in Japan, as well.
  
  Participant recruitment is particularly important when conducting clinical trials. In Japan, development on a framework for participation in research is currently underway through the Japan Trial-Ready Cohort (J-TRC), which aims to build a registry of people who can join studies for developing preventive medications for dementia.
  
  To further promote participation from people living with dementia, those in academia and the Government must communicate the goals and significance of each research initiative, expected results, and the impact and effects participating will have on society as well as on other people living with dementia, their families, and their caregivers. This must all be communicated in terms that are easy to understand. It is also necessary to be understanding of and considerate toward the physical and mental burdens that participating in research places on people with dementia, their families, and their caregivers.

 

• Establishing a system to facilitate smooth social implementation of R&D results
  In the future, it is inevitable that the number of prevalent cases of dementia in Japan will increase. To ensure the smooth social implementation of innovative DMTs for diseases that cause dementia, we must establish a system to appropriately assess innovation. When doing so, we must take into account target population scale as well as social and economic impact. We must also build social consensus on assessment methods. For example, the price of a disease-modifying pharmaceutical that was recently granted accelerated approval by the U.S. Food and Drug Administration (FDA) is attracting attention from the press in Japan and abroad. To assess innovation properly, it will be important to include people living with dementia, their families, and their caregivers when holding discussions on assessment. These discussions should not only take into account short-term costs; they should also cover medium- to long-term benefits to people with dementia, their families, and their caregivers, as well as to society and to the economy.
  
  It is also necessary to build a system for highly accurate, early diagnosis. If accurate, simple diagnostic techniques are established, it will lighten burdens placed on research participants, increase precision during participant selection for clinical trials, and enable the development of DMTs that more closely fit the physical conditions and characteristics of each person. Establishing this diagnostic system will be essential for implementing DMTs in society. Developing and disseminating DMTs targeting the preclinical period, when clinical symptoms can be difficult to detect, is especially important. Doing so will make it possible to identify people eligible for treatment and intervention through annual health checkups, medical examinations, and similar processes. In addition to further advances in conventional brain imaging tests, there are high expectations for research on blood and digital biomarkers and the development of diagnostic technologies that use blood and digital biomarkers. If these technologies are adopted and it becomes possible to conduct more accurate, simple examinations, those examinations can then be implemented in annual health checkups and medical examinations as a matter of public policy, thus improving access to early diagnosis.
  
  Findings from studies conducted abroad must also be adopted and implemented into Japanese society. An example of one such study is the Finnish Geriatric Intervention Study (the FINGER Study), which made Finland the first country to demonstrate the effects of lifestyle interventions on reducing cognitive decline among elderly people. A program for the social implementation of their findings is currently underway in Japan. Moving forward, it will be important to conduct basic research to identify the underlying mechanisms of dementia prevention and symptom improvement as well as research for the social implementation of evidence-based initiatives from abroad.

• Engaging in global collaboration through a research promotion platform that unites multi-stakeholders
  One of the goals set at the G8 Dementia Summit held in the U.K. in 2013 was identifying a DMT for dementia by 2025. The G8 ministers also agreed to increase research spending, increase the number of specialists involved in R&D, and share information like research data and findings globally. Since then, momentum for dementia R&D has grown around the world, but the scale of the field is still small compared to diseases like cancer. Also, infectious disease control became an urgent issue starting in 2019 due to the Coronavirus Disease 2019 (COVID-19) pandemic. People in many countries are concerned this will cause interest and public-private investment in dementia to stagnate.

  To avoid that from occurring, domestic and international stakeholders from industry, Government, academia, and civil society must continue communicating the importance of dementia R&D to the international community with a focus on people living with dementia, their families, and their caregivers. A platform for disseminating information to society and sharing knowledge, data, and best practices among all stakeholders must also be established. As mentioned at the symposium, we can look to Join Dementia Research in the U.K. as an example.

 

■Overview

• Date and time: July 12, 2021 17:00-20:00 (JST) (Local time in the U.K.: 9:00-12:00)
• Venue: Online using the Zoom conferencing system
• Hosted by: Health and Global Policy Institute (HGPI)
• Co-hosted by: Unit for Early and Exploratory Clinical Development, The University of Tokyo Hospital, World Dementia Council (WDC)
• Languages: Japanese and English with simultaneous interpretation

 

 ■Program (Titles omitted) *( ): UK local time

17:00-17:05 (9:00-9:05)  Welcoming Remarks and Explanatory Introduction
 Shunichiro Kurita (Manager, HGPI)

17:05-17:25 (9:05-9:25)  Keynote Lecture 1: “The Current Status and Future Prospects of Dementia Research and Development Policy in Japan”
 Toshihisa Tanaka (Special Officer for Dementia Policy and Assistant Section Chief, Division of Dementia Policy and Community-Based Long-Term Care Promotion, Health and Welfare Bureau for the Elderly, Ministry of Health, Labour and Welfare)

17:25-17:55 (9:25-9:55)  Keynote Lecture 2: “Future Issues and Prospects for Developing and Disseminating DMTs for Dementia – from academic perspective” 
 Takeshi Iwatsubo (Professor, Department of Basic Neuroscience, Department of Neurology, Graduate School of Medicine, The University of Tokyo; Director, Unit for Early and Exploratory Clinical Development, The University of Tokyo Hospital)

18:00-18:30 (10:00-10:30)  Keynote Lecture 3: “Activities of the WDC and Steps for Promoting Dementia Research and Development on the International Level”
 Lenny Shallcross (Executive Director, WDC)

18:40-19:50 (10:40-11:50)  Panel Discussion “Issues and Prospects for the Development and Dissemination of Disease Modifying Therapies for Dementia”
Panelists:
 Morio Suzuki (Representative Director, Alzheimer’s Association Japan)
 Kazuko Fujita (Representative Director, Japan Dementia Working Group)
 Takeshi Iwatsubo
 Toshihisa Tanaka
 Fiona Carragher (Director of Research and Influencing, Alzheimer’s Society)

Moderator:
 Ryoji Noritake (CEO, Board Member, HGPI)

19:50-20:00 (11:50-12:00)  Closing Remarks
 Kiyoshi Kurokawa (Chairman, HGPI; Committee Member/ Vice Chair, WDC)