Introduction: Tens of millions of people worldwide will develop Alzheimer's disease (AD), and only by intervening early in the preclinical disease can we make a fundamental difference to the rates of late-stage disease where clinical symptoms and societal burden manifest. However, collectively utilizing data, samples, and knowledge amassed by large-scale projects such as the Innovative Medicines Initiative (IMI)-funded European Prevention of Alzheimer's Dementia (EPAD) program will enable the research community to learn, adapt, and implement change. Method: In the current article, we define and discuss the substantial assets of the EPAD project for the scientific community, patient population, and industry, describe the EPAD structure with a focus on how the public and private sector interacted and collaborated within the project, reflect how IMI specifically supported the achievements of the above, and conclude with a view for future. Results: The EPAD project was a €64-million investment to facilitate secondary prevention of AD dementia research. The project recruited over 2,000 research participants into the EPAD longitudinal cohort study (LCS) and included over 400 researchers from 39 partners. The EPAD LCS data and biobank are freely available and easily accessible via the Alzheimer's Disease Data Initiative's (ADDI) AD Workbench platform and the University of Edinburgh's Sample Access Committee. The trial delivery network established within the EPAD program is being incorporated into the truly global offering from the Global Alzheimer's Platform (GAP) for trial delivery, and the almost 100 early-career researchers who were part of the EPAD Academy will take forward their experience and learning from EPAD to the next stage of their careers. Discussion: Through GAP, IMI-Neuronet, and follow-on funding from the Alzheimer's Association for the data and sample access systems, the EPAD assets will be maintained and, as and when sponsors seek a new platform trial to be established, the learnings from EPAD will ensure that this can be developed to be even more successful than this first pan-European attempt.
The IMI public-private partnership between the European Commission and the European Federation of Pharmaceutical Industries and Associations (EFPIA) was launched in 2008 with an initial budget of €2 billion. Aiming to accelerate the development of innovative medicines for areas of unmet clinical need, the IMI has committed over €380 million to projects on neurodegenerative disorders (NDD), catalyzing public-private collaborations at scale and at all stages of the R&D pipeline. Because of this vast investment, research on neurodegenerative diseases has made enormous strides in recent decades. The challenge for the future however remains to utilize this newly found knowledge and generated assets to develop better tools and novel therapeutic strategies. Here, we report the results of an integrated programme analysis of the IMI NDD portfolio, performed by the Neuronet Coordination and Support Action. Neuronet was launched by the IMI in 2019 to boost synergies and collaboration between projects in the IMI NDD portfolio, to increase the impact and visibility of research, and to facilitate interactions with related initiatives worldwide. Our analysis assessed the characteristics, structure and assets of the project portfolio and identifies lessons from projects spanning preclinical research to applied clinical studies and beyond. Evaluation of project parameters and network analyses of project partners revealed a complex web of 236 partnering organizations, with EFPIA partners often acting as connecting nodes across projects, and with a great diversity of academic institutions. Organizations in the UK, Germany, France and the Netherlands were highly represented in the portfolio, which has a strong focus on clinical research in Alzheimer's and Parkinson's disease in particular. Based on surveys and unstructured interviews with NDD research leaders, we identified actions to enhance collaboration between project partners, by improving the structure and definition of in-kind contributions; reducing administrative burdens; and enhancing the exploitation of outcomes from research investments by EU taxpayers and EFPIA. These recommendations could help increase the efficiency and impact of future public-private partnerships on neurodegeneration.
More and more frequently, clinical trials for Alzheimer disease (AD) are targeting cognitively unimpaired individuals who are at increased risk of developing the disease. It is not always clear whether AD biomarker information should be disclosed to research participants: on the one hand, research participants may be interested in learning this information because of its perceived utility, but on the other hand, learning this information may be harmful, as there are very few effective preventive or therapeutic options available for AD. In this article, we bring together three separate sets of ethical guidance literature: on the return of individual research results, on an individual's right to access personal data, and on transparent enrollment into clinical trials. Based on these literatures, we suggest policies for the disclosure of AD biomarker test results in longitudinal observational cohort studies, clinical trials, and hybrid research projects, such as the European Prevention of Alzheimer's Dementia (EPAD) project, in which we served as an ethics team. We also present and critically discuss recommendations for disclosure of AD biomarkers in practice. We underscore that, as long as the clinical validity of AD biomarkers remains limited, there are good reasons to avoid actively disclosing them to cognitively unimpaired research participants.
The Public Involvement (PI) of people with dementia is slowly but progressively moving from a “nice to have” to a “must have” element of good-quality dementia research. Research funders and ethics committees increasingly ask for evidence of the planning of such involvement. The actual conduct and outcome of PI are, however, unfortunately typically under or inadequately reported. In this article, we provide an overview of what PI is and why it is important to dementia research and Alzheimer Europe's approach to PI. We draw on our recent experience of compiling a set of examples of PI in different European projects in publicly available sources. This highlighted the difficulty of finding information about PI activities and the almost total lack of details of such activities in formal reports, official records, and/or public project websites. In this article, we emphasize gaps and call for more stringent conditions for the inclusion and reporting of PI work in the context of the approval and funding of dementia research projects. We call for the establishment of obligatory reporting on the nature, specific challenges, and impact of PI in dementia research in formal reports (e.g., to funders), in public project websites, and in peer-reviewed articles. Such reporting should cover several key factors such as who was involved, how they were involved, and what impact PI had on the research process.
Introduction: Etiological diagnosis of neurocognitive disorders of middle-old age relies on biomarkers, although evidence for their rational use is incomplete. A European task force is defining a diagnostic workflow where expert experience fills evidence gaps for biomarker validity and prioritization. We report methodology and preliminary results. Methods: Using a Delphi consensus method supported by a systematic literature review, 22 delegates from 11 relevant scientific societies defined workflow assumptions. Results: We extracted diagnostic accuracy figures from literature on the use of biomarkers in the diagnosis of main forms of neurocognitive disorders. Supported by this evidence, panelists defined clinical setting (specialist outpatient service), application stage (MCI-mild dementia), and detailed pre-assessment screening (clinical-neuropsychological evaluations, brain imaging, and blood tests). Discussion: The Delphi consensus on these assumptions set the stage for the development of the first pan-European workflow for biomarkers' use in the etiological diagnosis of middle-old age neurocognitive disorders at MCI-mild dementia stages. Highlights: Rational use of biomarkers in neurocognitive disorders lacks consensus in Europe. A consensus of experts will define a workflow for the rational use of biomarkers. The diagnostic workflow will be patient-centered and based on clinical presentation. The workflow will be updated as new evidence accrues.
Introduction: Clear communication of diagnostic test results and dementia diagnosis is challenging yet important to empower patients and care partners. A personalized diagnostic report could support the communication of dementia diagnostics and aid patients' understanding of diagnosis. In this study, we aimed to design a diagnostic report in co-creation with patients and care partners. Methods: We used a mixed-methods approach, combining surveys with focus groups in iteration. Phase 1 consisted of an international survey assessing needs among patients (n = 50) and care partners (n = 46), and phase 2 consisted of focus group meetings (n = 3) to co-create the content and to hands-on co-design the layout of the diagnostic report with patients (n = 7) and care partners (n = 7). Phase 3 validated results from phase 2 in a survey among patients (n = 28) and care partners (n = 12), and phase 4 comprised final feedback by dementia (care) experts (n = 5). Descriptive statistics were used to report quantitative results and directed content analysis was used to analyze qualitative data. Results: Most patients (39/50, 78%) and care partners (38/46, 83%) positively valued a diagnostic report to summarize test results. The report should be brief, straightforward, and comprise results of the diagnostic tests, including brain imaging and information on future expectations. Despite a clear preference for visual display of test results, several visualization options were deemed best and were equally comprehended. Discussion: In this study, we developed a prototype of a personalized patient report through an iterative design process and learned that co-creation is highly valuable to meet the specific needs of end-users.
Aims We aim to identify existing empowerment interventions for people living with dementia and to explore which used interventions and projects are considered empowering and why. Design This was an online survey. Methods We conducted an online survey between May 2018 and July 2018 amongst professionals interested in dementia care in Europe. Interventions were clustered within the ecological model for health promotion. Reasons from respondents as to why they considered interventions to be empowering were analysed and structured according to a recently developed conceptual framework of empowerment for people living with dementia. Results Seventy‐three respondents from 23 countries together mentioned 98 interventions or projects, of which 90 were unique. Interventions focused on the (inter)personal (n = 54), organizational (n = 15), communal (n = 6) and societal (n = 15) levels. A broad range of interventions were considered empowering, but no interventions were specifically developed for, nor aimed at, empowerment. Reasons as to why respondents considered these interventions as empowering fitted the framework's domains. Conclusion This European survey provides insights into interventions considered empowering for people living with dementia. An important step that needs to be taken is to develop and test interventions that specifically aim to promote empowerment for people living with dementia. Impact Empowerment may encourage people with dementia to live the life they choose, and focus on what is possible, instead of what is no longer possible. Many interventions are considered as empowering for people living with dementia, however no interventions could be identified that were specifically developed for or aimed at empowerment. This study shows that for promoting empowerment, it is necessary to develop and test interventions that specifically aim for empowerment, do this in collaboration with relevant stakeholders, and in this way support people living with dementia to live according to their competencies, talents and wishes.
Introduction: Global estimates on numbers of persons in early stages of Alzheimer's disease (AD), including prodromal and preclinical, are lacking, yet are needed to inform policy decisions on preventive measures and planning for future therapies targeting AD pathology. Methods: We synthesized the literature on prevalence across the AD continuum and derived a model estimating the number of persons, stratified by 5-year age groups, sex, and disease stage (AD dementia, prodromal AD, and preclinical AD). Results: The global number of persons with AD dementia, prodromal AD, and preclinical AD were estimated at 32, 69, and 315 million, respectively. Together they constituted 416 million across the AD continuum, or 22% of all persons aged 50 and above. Discussion: Considering predementia stages, the number of persons with AD is much larger than conveyed in available literature. Our estimates are uncertain, especially for predementia stages in low- and middle-income regions where biomarker studies are missing.
Introduction: Harmonized neuropsychological assessment for neurocognitive disorders, an international priority for valid and reliable diagnostic procedures, has been achieved only in specific countries or research contexts. Methods: To harmonize the assessment of mild cognitive impairment in Europe, a workshop (Geneva, May 2018) convened stakeholders, methodologists, academic, and non-academic clinicians and experts from European, US, and Australian harmonization initiatives. Results: With formal presentations and thematic working-groups we defined a standard battery consistent with the U.S. Uniform DataSet, version 3, and homogeneous methodology to obtain consistent normative data across tests and languages. Adaptations consist of including two tests specific to typical Alzheimer's disease and behavioral variant frontotemporal dementia. The methodology for harmonized normative data includes consensus definition of cognitively normal controls, classification of confounding factors (age, sex, and education), and calculation of minimum sample sizes. Discussion: This expert consensus allows harmonizing the diagnosis of neurocognitive disorders across European countries and possibly beyond.
The importance of Public Involvement (PI) is increasingly being recognized in the field of dementia research. In 2012, Alzheimer Europe set up the European Working Group of People with Dementia (EWGPWD) which provides advice and input for all activities of the organization including several large European-funded research projects. The German Center for Neurodegenerative Diseases (DZNE) created a research advisory patient board in 2020 with the intention of supporting the board in strategic research decisions. Both groups are composed of people with dementia and act independently. With the aim of finding out whether PI in research is mutually rewarding and beneficial, members of both groups were asked about their motivation to be involved in PI research activities and the value this had for them. This was collected either through narrative interviews or during meetings. People with dementia described several reasons for being involved in PI activities in dementia research.
Background: Mobile health (mHealth) has the potential to bring preventive healthcare within reach of populations with limited access to preventive services, by delivering personalized support at low cost. Although numerous mHealth interventions are available, very few have been developed following an evidence-based rationale or have been tested for efficacy. This article describes the systematic development of a coach-supported mHealth application to improve healthy lifestyles for the prevention of dementia and cardiovascular disease in the United Kingdom (UK) and China. Methods: Development of the Prevention of Dementia by Mobile Phone applications (PRODEMOS) platform built upon the experiences with the Healthy Aging Through Internet Counseling in the Elderly (HATICE) eHealth platform. In the conceptualization phase, experiences from the HATICE trial and needs and wishes of the PRODEMOS target population were assessed through semi-structured interviews and focus group sessions. Initial technical development of the platform was based on these findings and took place in consecutive sprint sessions. Finally, during the evaluation and adaptation phase, functionality and usability of the platform were evaluated during pilot studies in UK and China. Results: The PRODEMOS mHealth platform facilitates self-management of a healthy lifestyle by goal setting, progress monitoring, and educational materials on healthy lifestyles. Participants receive remote coaching through a chat functionality. Based on lessons learned from the HATICE study and end-users, we made the intervention easy-to-use and included features to personalize the intervention. Following the pilot studies, in which in total 77 people used the mobile application for 6 weeks, the application was made more intuitive, and we improved its functionalities. Conclusion: Early involvement of end-users in the development process and during evaluation phases improved acceptability of the mHealth intervention. The actual use and usability of the PRODEMOS intervention will be assessed during the ongoing PRODEMOS randomized controlled trial, taking a dual focus on effectiveness and implementation outcomes.
Computer tools aid clinicians by combining test results and facilitating interpretation, in reaching decisions and communication, on both diagnosis and prognosis. Nevertheless, to date, such tools are hardly used in daily clinical practice. To optimally meet the needs of end‐users, as a prerequisite for further development and implementation of computer tools, we set out to identify barriers and facilitators for the use of computer tools in memory clinics according to clinicians. In addition, we aimed to synthesize the opinions of patients and caregivers about this topic. Between July and October 2020, 109 European clinicians (45±10y, 49% F) completed an online survey on their views regarding the use of diagnostic and prognostic tools. Questions related to the willingness of using tools and factors that would hinder or stimulate the use. Furthermore, 50 European patients with SCD, MCI or dementia (73±8y, 34% F) and 46 caregivers (65±12y, 54% F) completed an alternative survey focused on their opinion. The vast majority of clinicians reported a willingness to use diagnostic (80%) and prognostic (77%) computer tools. Increasing diagnostic accuracy was reported as the main factor to stimulate the use of a tool. In addition, clinicians indicated that tools should be easy to understand, time‐saving, and providing clear information on reliability and validity (Fig 1). Inadequate integration with electronic patient files and fear of losing important clinical information were most frequently indicated as barriers (Fig 1). Patients and caregivers were also positive about the use of computer tools by clinicians, both for diagnosis (71%) and prognosis (77%). They viewed computer tools as an addition to the current way of working, appropriate to modern times (Fig 2). This study shows that most end‐users are in favor of using computer tools in memory clinics, for diagnosis and prognosis. In order to stimulate implementation of computer tools, it is key to maximize the extracted information and to optimize integration with electronic patient files, while simultaneously provide clear information about reliability and validity. These insights pave the way for the further development of computer tools that meet the needs of end‐users and, consequently, successful implementation.
Growing evidence suggests dementia incidence can be reduced through prevention programs targeting risk factors. To accelerate the implementation of such prevention programs, a new generation of brain health services (BHS) is envisioned, involving risk profiling, risk communication, risk reduction, and cognitive enhancement. The purpose of risk communication is to enable individuals at risk to make informed decisions and take action to protect themselves and is thus a crucial step in tailored prevention strategies of the dementia incidence. However, communicating about dementia risk is complex and challenging. In this paper, we provide an overview of (i) perspectives on communicating dementia risk from an ethical, clinical, and societal viewpoint; (ii) insights gained from memory clinical practice; (iii) available evidence on the impact of disclosing APOE and Alzheimer’s disease biomarker test results gathered from clinical trials and observational studies; (iv) the value of established registries in light of BHS; and (v) practical recommendations regarding effective strategies for communicating about dementia risk. In addition, we identify challenges, i.e., the current lack of evidence on what to tell on an individual level—the actual risk—and on how to optimally communicate about dementia risk, especially concerning worried yet cognitively unimpaired individuals. Ideally, dementia risk communication strategies should maximize the desired impact of risk information on individuals’ understanding of their health/disease status and risk perception and minimize potential harms. More research is thus warranted on the impact of dementia risk communication, to (1) evaluate the merits of different approaches to risk communication on outcomes in the cognitive, affective and behavioral domains, (2) develop an evidence-based, harmonized dementia risk communication protocol, and (3) develop e-tools to support and promote adherence to this protocol in BHSs. Based on the research reviewed, we recommend that dementia risk communication should be precise; include the use of absolute risks, visual displays, and time frames; based on a process of shared decision-making; and address the inherent uncertainty that comes with any probability.
Background: Prognostic studies in the context of Alzheimer's disease (AD) mainly predicted time to dementia. However, it is questionable whether onset of dementia is the most relevant outcome along the AD disease trajectory from the perspective of patients and their care partners. Therefore, we aimed to identify the most relevant outcomes from the viewpoint of patients and care partners. Methods: We used a two-step, mixed-methods approach. As a first step we conducted four focus groups in the Netherlands to elicit a comprehensive list of outcomes considered important by patients (n = 12) and care partners (n = 14) in the prognosis of AD. The focus groups resulted in a list of 59 items, divided into five categories. Next, in an online European survey, we asked participants (n = 232; 99 patients, 133 care partners) to rate the importance of all 59 items (5-point Likert scale). As participants were likely to rate a large number of outcomes as "important" (4) or "very important" (5), we subsequently asked them to select the three items they considered most important. Results: The top-10 lists of items most frequently mentioned as "most important" by patients and care partners were merged into one core outcome list, comprising 13 items. Both patients and care partners selected outcomes from the category "cognition" most often, followed by items in the categories "functioning and dependency" and "physical health." No items from the category "behavior and neuropsychiatry" and "social environment" ended up in our core list of relevant outcomes. Conclusion: We identified a core list of outcomes relevant to patients and care partner, and found that prognostic information related to cognitive decline, dependency, and physical health are considered most relevant by both patients and their care partners.
In a just society, everyone should have equal access to healthcare in terms of prevention, assessment, diagnosis, treatment and care. Europe is a multicultural society made up of people who identify with a wide range of ethnic groups. Many older people from minority ethnic groups also have a direct migration background. Several studies have shown that there is a lack of equity in relation to dementia diagnoses and care because equal opportunities do not necessarily translate into equal outcomes. An expert ethics working group led by Alzheimer Europe has produced an extensive report on this issue, a policy brief and a guide for health and social care workers. In this brief summary, the authors/members of the expert working group present some of the key challenges and recommendations for healthcare clinicians striving to provide timely diagnosis and good quality care and treatment to people with dementia from all ethnic groups. This article is protected by copyright. All rights reserved. The number of people with dementia from minority ethnic groups is steadily increasingTimely diagnosis is essential for access to equal and appropriate dementia care for everyoneA range of interacting factors and structural discrimination hinders such timely diagnosisClinicians need access to training and culturally sensitive/fair and appropriately validated screening, assessment and diagnostic tools for people from minority ethnic groups The number of people with dementia from minority ethnic groups is steadily increasing Timely diagnosis is essential for access to equal and appropriate dementia care for everyone A range of interacting factors and structural discrimination hinders such timely diagnosis Clinicians need access to training and culturally sensitive/fair and appropriately validated screening, assessment and diagnostic tools for people from minority ethnic groups
The chapter focuses on the topics of timely diagnosis, disclosure of the diagnosis (e.g. quality of the disclosure, reactions and sharing the diagnosis with others) and the provision of appropriate support and care after diagnosis (e.g. information received, care and support at the time of diagnosis). Each section begins with a brief overview of key issues related to the topic and how these should be addressed from an ethical and human rights perspective. This is followed by a reflection on the current situation and practices based on a five-country survey on the experiences of diagnosis and post-diagnostic support of family carers for a relative with dementia. The final part of the chapter highlights issues that need to be addressed and improved and provides some recommendations.
Introduction: The Models of Patient Engagement for Alzheimer's Disease (MOPEAD) project was conceived to explore innovative complementary strategies to uncover hidden prodromal and mild Alzheimer's disease (AD) dementia cases and to raise awareness both in the general public and among health professionals about the importance of early diagnosis. Methods: Four different strategies or RUNs were used: (a) a web-based (WB) prescreening tool, (2) an open house initiative (OHI), (3) a primary care-based protocol for early detection of cognitive decline (PC), and (4) a tertiary care-based pre-screening at diabetologist clinics (DC). Results: A total of 1129 patients at high risk of having prodromal AD or dementia were identified of 2847 pre-screened individuals (39.7%). The corresponding proportion for the different initiatives were 36.8% (WB), 35.6% (OHI), 44.4% (PC), and 58.3% (DC). Conclusion: These four complementary pre-screening strategies were useful for identifying individuals at high risk of having prodromal or mild AD.
Background The PARADIGM consortium aimed to make patient engagement in the development and lifecycle management of medicines easier and more effective for all, with the development of new tools that fulfil robustly defined gaps where engagement is suboptimal. Aims To generate an inventory of gaps in patient engagement practices and process from existing global examples. Methods A large set of criteria for effective patient engagement previously defined via a multi-stakeholder Delphi method, were mapped under fourteen overarching themes. A gap analysis was then performed by twenty-seven reviewers against the resulting forty-six mapped criteria, on a sample of seventy initiatives from global databases. Results An inventory of gaps was identified including contextual information as to why the gaps exist. Our work identified general patterns where patient engagement was suboptimal—defined as; fragmented reporting and dissemination of patient engagement activities, and the fundamental principles defined in frameworks or guidance being poorly adhered to in actual practice. Specific gaps were identified for sixteen criteria. Additionally, it was also common to observe primary aspects of a process were addressed for a given criteria (i.e. training for roles and responsibilities) but a secondary context element was lacking (i.e. making training material accessible/understandable/meaningful to all participants). Conclusion The results show that the evolution towards meaningful and systematic patient engagement is occurring, yet more importantly they provide clear directional insights to help enhance collaborative practices and co-design solutions. This targeted impact to catalyse a needs-oriented health system that integrates patient engagement at its core is essential.
Background Computer tools based on artificial intelligence could aid clinicians in memory clinics in several ways, such as by supporting diagnostic decision-making, web-based cognitive testing, and the communication of diagnosis and prognosis. Objective This study aims to identify the preferences as well as the main barriers and facilitators related to using computer tools in memory clinics for all end users, that is, clinicians, patients, and care partners. Methods Between July and October 2020, we sent out invitations to a web-based survey to clinicians using the European Alzheimer’s Disease Centers network and the Dutch Memory Clinic network, and 109 clinicians participated (mean age 45 years, SD 10; 53/109, 48.6% female). A second survey was created for patients and care partners. They were invited via Alzheimer Europe, Alzheimer’s Society United Kingdom, Amsterdam Dementia Cohort, and Amsterdam Aging Cohort. A total of 50 patients with subjective cognitive decline, mild cognitive impairment, or dementia (mean age 73 years, SD 8; 17/34, 34% female) and 46 care partners (mean age 65 years, SD 12; 25/54, 54% female) participated in this survey. Results Most clinicians reported a willingness to use diagnostic (88/109, 80.7%) and prognostic (83/109, 76.1%) computer tools. User-friendliness (71/109, 65.1%); Likert scale mean 4.5, SD 0.7), and increasing diagnostic accuracy (76/109, 69.7%; mean 4.3, SD 0.7) were reported as the main factors stimulating the adoption of a tool. Tools should also save time and provide clear information on reliability and validity. Inadequate integration with electronic patient records (46/109, 42.2%; mean 3.8, SD 1.0) and fear of losing important clinical information (48/109, 44%; mean 3.7, SD 1.2) were most frequently indicated as barriers. Patients and care partners were equally positive about the use of computer tools by clinicians, both for diagnosis (69/96, 72%) and prognosis (73/96, 76%). In addition, most of them thought favorably regarding the possibility of using the tools themselves. Conclusions This study showed that computer tools in memory clinics are positively valued by most end users. For further development and implementation, it is essential to overcome the technical and practical barriers of a tool while paying utmost attention to its reliability and validity.
Introduction Profiles of high risk for future dementia are well understood and are likely to concern mostly those in low-income and middle-income countries and people at greater disadvantage in high-income countries. Approximately 30%–40% of dementia cases have been estimated to be attributed to modifiable risk factors, including hypertension, smoking and sedentary lifestyle. Tailored interventions targeting these risk factors can potentially prevent or delay the onset of dementia. Mobile health (mHealth) improves accessibility of such prevention strategies in hard-to-reach populations while at the same time tailoring such approaches. In the current study, we will investigate the effectiveness and implementation of a coach-supported mHealth intervention, targeting dementia risk factors, to reduce dementia risk. Methods and analysis The prevention of dementia using mobile phone applications (PRODEMOS) randomised controlled trial will follow an effectiveness–implementation hybrid design, taking place in the UK and China. People are eligible if they are 55–75 years old, of low socioeconomic status (UK) or from the general population (China); have ≥2 dementia risk factors; and own a smartphone. 2400 participants will be randomised to either a coach-supported, interactive mHealth platform, facilitating self-management of dementia risk factors, or a static control platform. The intervention and follow-up period will be 18 months. The primary effectiveness outcome is change in the previously validated Cardiovascular Risk Factors, Ageing and Incidence of Dementia dementia risk score. The main secondary outcomes include improvement of individual risk factors and cost-effectiveness. Implementation outcomes include acceptability, adoption, feasibility and sustainability of the intervention. Ethics and dissemination The PRODEMOS trial is sponsored in the UK by the University of Cambridge and is granted ethical approval by the London—Brighton and Sussex Research Ethics Committee (reference: 20/LO/01440). In China, the trial is approved by the medical ethics committees of Capital Medical University, Beijing Tiantan Hospital, Beijing Geriatric Hospital, Chinese People’s Liberation Army General Hospital, Taishan Medical University and Xuanwu Hospital. Results will be published in a peer-reviewed journal. Trial registration number ISRCTN15986016 .
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