Dementia has been declared a public health priority by the World Health Organization (WHO)[1, 2], which has also prioritized research into dementia prevention. Risk reduction and prevention are pivotal in managing the dementia epidemic globally, and the sharing of data is vital to informing this process. World Wide FINGERS will facilitate the use of data from several countries, creating a unique opportunity for rapid knowledge dissemination and implementation.
The Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) trial is the first randomized controlled trial (RCT) showing that it is possible to prevent cognitive decline using a multidomain lifestyle intervention among older at-risk individuals. The results from this trial led by Professor Miia Kivipelto and team highlighted the value of addressing multiple dementia risk factors as a strategy to protect brain health, promote overall health and functioning, and reduce the risk of developing new chronic diseases [3,4,5].
Prevention of cognitive impairment requires integrated approaches targeting risk factors shared by chronic disorders common in older age. This is the definition of accessible and sustainable strategies for populations within different geographical, economic and cultural settings.
WW-FINGERS was established to support and convene global multidomain dementia prevention trials, share experiences and data, and harmonize methods. Professor Kivipelto is the founder and scientific lead of the WW-FINGERS Network, which includes investigator teams from around the world.
Investigating teams will test the effects of multidomain lifestyle interventions, modeled after FINGER, on brain health and dementia prevention in diverse populations.
In 2018, WW-FINGERS trials had been planned in several European countries, the United States, China, Singapore and Australia. Currently, discussions are ongoing for similar efforts in Central and South America, Canada, India, Japan, South Korea and Malaysia (Figure 1).
The WW-FINGER Network comprises studies at different stages of implementation and with varying graduations of alignment to the FINGER trial. For instance, in the United States through the Alzheimer’s Association, U.S. POINTER is actively recruiting participants and the intervention and outcomes assessment are harmonized with FINGER. To help classify and understand the status of the WW-FINGERS trials, the network has agreed on the definition of four main levels, which reflect the trials’ key features, including current status (e.g., from RCTs still in the planning stage to those in which follow up of participants is available); funding availability; and degree of alignment with the FINGER RCT, in terms of design, intervention being tested and assessment of cognitive outcomes (Figure 2). Each study in the WW-FINGERS Network can be assigned to a level, and mobility among levels is expected.
The Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) (FINLAND)
FINGER (ClinicalTrials.gov NCT01041989) is an ongoing multi-center randomized controlled trial (intervention study) carried out in Finland (coordinated by the Finnish Institute of Health and Welfare, Helsinki), in collaboration with Karolinska Institutet (Sweden), testing the effect of a multidomain intervention in delaying cognitive impairment and disability in elderly persons at increased risk of dementia. FINGER enrolled 1,260 participants aged 60-77 years recruited from previous population-based survey cohorts. Inclusion criteria were: CAIDE Dementia Risk Score ≥6 points, indicating the presence of modifiable risk factors; and cognitive performance at the mean level or slightly lower than expected for age. Participants were randomized (1-1) into either the multidomain intervention group or the control group. The intervention included nutritional guidance, physical exercise, cognitive training, social activities and management of vascular and metabolic risk factors. The control group received regular health advice.
After two years, cognition, assessed using the comprehensive neuropsychological test battery (NTB), improved by approximately 25% more in the multidomain intervention group. Performance was improved in all cognitive sub-domains including executive function, processing speed and complex memory tasks. The FINGER multidomain intervention benefitted cognition regardless of sociodemographic and socioeconomic factors or other baseline characteristics. Moreover, individuals with genetic susceptibility to Alzheimer's disease (APOE4 carriers) had clear cognitive benefits from the intervention. Additional beneficial effects of the intervention included: reduced the risk of developing new chronic diseases, reduced risk of functional decline and improved health-related quality of life. A rich biorepository is available for ongoing investigations on mediating intervention pathways, and definition of biosignatures reflecting risk levels and intervention response.
Extended follow-up of the study participants is ongoing to measure the long-term effects of the multidomain intervention. The 5 and 7-year extended follow-up were completed in 2016 and 2018, respectively. The 10-year follow-up will start in 2020.
For more information visit the FINGER website or contact Miia Kivipelto or Tiia Ngandu.
The Alzheimer's Association U.S. Study to Protect Brain Health Through Lifestyle Intervention to Reduce Risk trial (USA)
World-renowned researchers, under the leadership of Drs. Laura Baker, Mark Espeland, Miia Kivipelto and Rachel Whitmer, in collaboration with the Alzheimer’s Association, have initiated efforts to replicate the results of the Finnish trial in the U.S. (to test the generalizability of the FINGER findings in Americans). U.S. POINTER is a 2-year clinical trial that will enroll approximately 2,000 cognitively normal adults who are at increased risk for cognitive decline to evaluate whether lifestyle interventions that simultaneously target many risk factors can protect cognitive function. To build on lessons learned from FINGER, U.S. POINTER study candidates will be identified through medical record review as well as through additional information obtained by questionnaire, such as family history.
U.S. POINTER is the first such study to be conducted in a large group of Americans across the United States. Recruitment began in January 2019 in North Carolina in partnership with Wake Forest School of Medicine, and has since expanded to four other sites that include Northern California in partnership with the University of California-Davis, the Chicago, Illinois area in partnership with Rush University and Advocate Health Care, the Houston, Texas area in partnership with Baylor College of Medicine and Kelsey Research, and the New England Rhode Island area in partnership with Brown University. Additional substudies are funded by the National Institute on Aging to collect brain imaging MRI and PET data, objective sleep data and gut microbiome data. U.S. POINTER represents a once-in-a-lifetime opportunity for participants and researchers.
For more information visit the U.S. POINTER website or contact email@example.com.
Singapore Intervention Study to Prevent Cognitive Impairment and Disability (SINGER) study
The Singapore intervention study to prevent cognitive impairment and disability (SINGER) is a pilot study aiming to evaluate culturally appropriate adaptations of the FINGER intervention. In the planned study, 70 seniors (>65 years) with mild-to-moderate frailty and/or cognitive impairment will be followed for a six-month period. The main outcome of this pilot study is the feasibility of and adherence to the multidomain intervention with the ultimate goal to eventually undertake a large confirmatory study. There are challenges, particularly for the dietary and cognitive interventions in Singapore, that may require novel and culturally appropriate approaches.
For more information contact Christopher Chen.
The Multimodal Preventive Trial for Alzheimer’s Disease (MIND-ADmini) (SWEDEN, FINLAND, FRANCE, GERMANY)
MIND-ADmini is a pilot trial testing the feasibility of the FINGER multidomain lifestyle intervention in people with prodromal Alzheimer’s disease. Participants are in the early stages of the disease and have mild memory problems, but not dementia. They also have some vascular or lifestyle-related risk factors.
Conducting a pilot trial in people who already have some Alzheimer’s disease symptoms is important because of the potential need for additional support with healthy lifestyle maintenance. The duration of the trial is six months, with an optional 6-month extension. Participants are randomized into three groups: multidomain lifestyle intervention based on the FINGER model, multidomain lifestyle intervention plus medical food, and standard care. The rationale for combining a multidomain intervention with medical food is recent evidence indicating synergistic effects between different intervention components (e.g., omega-3 fatty acids and physical activity). Nutrient deficiencies have also been described in prodromal Alzheimer’s disease, and medical food may be needed in addition to dietary guidance for optimal effect.
The main aims of MIND-ADmini are to evaluate the feasibility of and adherence to the multidomain intervention. Exploratory aims include intervention effects on changes in vascular and metabolic risk factors; depressive, anxiety and stress symptoms; cognition; health-related quality of life; and physical performance. Blood samples are collected for exploring mechanisms and mediating pathways of the multidomain intervention. There is also a qualitative interview study focusing specifically on the experiences of the trial participants.
MIND-ADmini now includes 92 participants and will be completed in December 2019.
Results will be used in the planning of future larger trials and may serve as a model for combining non-pharmacological and pharmacological interventions.
For more information contact Alina Solomon.
The AUstralian Multidomain Approach to Reduce Dementia Risk by Protecting Brain Health with Lifestyle Intervention (AU-ARROW) study (AUSTRALIA)
Ralph Martins is the lead investigator of the lifestyle arm of the Australian Imaging, Biomarker & Lifestyle Study of Ageing (AIBL) in Australia, and an internationally renowned scientist in the field of dementia research. Martins will be leading a team of internationally recognized Australian researchers which include Kaarin Anstey and Sharon Naismith. This Australian team will collaborate closely with Laura Baker (U.S. POINTER) to commence an Australian version, namely, the AU-ARROW trial. The Australian team will also work closely with Miia Kivipelto, who undertook seminal work in the Finnish FINGER trial and Dr. Maria Carrillo from the Alzheimer's Association.
The AU-ARROW study will follow closely the study methods detailed in the FINGER and U.S. POINTER protocols, though some minor modifications may be necessary to adapt the study protocol to the Australian lifestyle. The study involves a 2-year multidomain lifestyle intervention program comprising physical exercise, computerized brain braining, social engagement, diet and medical counselling. The study will randomize 600 participants aged 60-79 into two groups: a group that will receive health education and support; and a multidomain intervention group. In line with the WW-FINGERS initiative, the AU-ARROW study aims to evaluate the efficacy of the multidomain lifestyle intervention for the prevention of cognitive decline, as measured using a range of neuropsychological tests, matching those used in the FINGER and POINTER trials. Additional AU-ARROW study assessments include blood, brain and retinal biomarker analysis.
This Australian initiative is a unique opportunity for participants and researchers in Perth, Western Australia, and Sydney, New South Wales.
For more information contact Ralph Martins.
The Multimodal Interventions to Delay Dementia and Disability in Rural China (MIND-CHINA) study (CHINA)
In the past two to three decades, China has seen a steady increase in the age-specific prevalence of Alzheimer’s disease and other dementias, along with rapid health transition characterized by the rise of non-communicable chronic diseases driven primarily by urbanization, socioeconomic development and population aging.
Inspired by the FINGER project, we launch the MIND-CHINA project, which is a single-center cluster randomized controlled study that is aimed at investigating whether multimodal interventions may help maintain cognitive and physical functioning among rural-dwelling older adults. The interventions target people who are aged 60-79 years and living in the rural communities of Yanlou Town in Yanggu County, Western Shandong Province. Baseline assessments were completed in March-September 2018, followed by a pilot study in June-October 2019. Recruitment of participants for interventions began in November 2019 and up to 3,000 participants will be randomized into three groups: a group that will receive regular health care services provided by local government; a vascular intervention group that will be treated pharmacologically to control three major vascular risk factors (high blood pressure, high blood glucose and dyslipidemia); or a multimodal intervention group in addition to pharmacological intervention of three vascular risk factors. In addition, an MRI substudy is planned within MIND-CHINA.
MIND-CHINA is being conducted by the Shandong Provincial Hospital Affiliated to Shandong University, led by Yifeng Du and coordinated by Yongxiang Wang in collaboration with senior researchers from Karolinska Institutet, Stockholm, Sweden (Chengxuan Qiu and Miia Kivipelto). MIND-CHINA is supported in part by a major grant from the National Key R&D Program of China and a Sino-Sweden joint research project grant from the National Natural Science Foundation of China (NSFC) and the Swedish Research Council (VR).
For more information contact Yifeng Du, Yongxiang Wang or Chengxuan Qiu.
GOIZ-ZAINDU, the Basque words for “caring early”, is a one-year pilot RCT testing the feasibility of the FINGER multidomain intervention in the Basque population in Spain. Launched in June 2018, GOIZ-ZAINDU tries to adapt the FINGER methodology to the cultural and social context of the Basque population, and evaluate the feasibility of a multidomain lifestyle intervention program. The exploratory aim is to assess the efficacy of the intervention to reduce participants CAIDE risk scores and reduce cognitive decline.
The study participants are people aged 60+ years, selected through a method similar to the one used in FINGER: increased risk of dementia, based on a CAIDE total score of six points or higher, and below-than-expected cognitive performance in at least one of three brief cognitive screening tests. Over 200 participants from the Municipality of Beasain, were screened and 130 participants completed the assessment and fulfilled inclusion criteria. Stratification by cognitive status (mild cognitive impairment and normal cognition) was performed before randomization to a multidomain intervention or to standard of care. Multidomain intervention includes nutritional advice, physical activity, cognitive training and monitoring of vascular risk factors. In early 2020, a post-intervention evaluation will be performed and participants’ performance will be evaluated. Intervention adherence and integration in the current health system is demonstrating the study's main objective.
This is the first study conducted in Southern Europe to evaluate a multidomain intervention in the prevention of cognitive decline. Investigators current efforts are directed to design a larger efficacy trial to provide knowledge for the public health strategies on healthy aging and dementia prevention. This is a unique opportunity to investigate the multi-factorial origin of dementia. This initiative will include an ambitious protocol with extensive clinical, cognitive, imaging and biological data that will increase knowledge on the interactions and mechanisms of action that ultimately lead to cognitive and functional decline.
The GOIZ-ZAINDU project is performed and funded by the CITA-Alzheimer Foundation in collaboration with the Municipality of Beasain and Osakidetza (the public Basque Health System) and receives partial funding support from the Department of Health of the Government of the Basque Country.
For more information visit the GOIZ-ZAINDU website or contact Dr. Mikel Tainta or Dr. Pablo Martinez-Lage.
India FINGER comprises two longitudinal cohort studies of aging in India – one in an urban population and another in a rural population. The Tata Longitudinal Study of Aging (TLSA) in urban Bangalore and the Srinivaspura Aging, Neuro Senescence and COGnition (SANSCOG) study in rural Kolar district are both enrolling adults 45 years or older. Similar assessments are used in both studies, including a cognitive battery comparable to that used in FINGER, adapted for culture and education across India. The contrasts observed between the urban and rural populations differ across many domains, including education, language, socialization, prevalence of cardiovascular risk factors and nutritional deficiencies. Observations made in these studies will be paramount to help inform a future FINGER-type intervention study.
The TLSA study (Bangalore) is funded by the Tata Trusts.
To learn more, contact Naren Rao.
A Pragmatic Multi-center Cluster-randomized Controlled Prevention Trial Against Cognitive Decline in Older Primary Care Patients (AgeWell.de) (GERMANY)
AgeWell.de is a 2-year multi-center control trial aimed to reduce the risk of cognitive decline. This study will be conducted across five study sites in Germany, and is coordinated by the Institute of Social Medicine, Occupational Health and Public Health (ISAP) at the University of Leipzig. AgeWell.de will involve over 1,000 community-dwelling primary care individuals aged 60-77 years thought to be at increased dementia risk for later life dementia (CAIDE Dementia Risk Score ≥ 9). General practitioner (GP) practices are randomized to either intervention A (advanced) or B (basic) in a 1-1 ratio. Intervention A is a multi-component intervention including nutritional counseling, physical activity, cognitive training, optimization of medication, management of vascular risk factors, social activity, and, if necessary, further specific interventions targeting grief and depression. Intervention B includes general health advice and GP treatment as usual.
AgeWell.de is funded by the German Federal Ministry for Education and Research.
For more information contact Susanne Röhr or Steffi G. Riedel-Heller.
Latin America FINGERS (LatAm FINGERS) is currently in the planning stages and will bring together leadership from Argentina, Bolivia, Brazil, Chile, Colombia, Costa Rica, Cuba, Ecuador, Mexico, Paraguay, Peru, Puerto Rico, Dominican Republic and Uruguay. The proposed pilot study will enroll a total of 1,400 participants (100 participants per country) and is designed to align with the FINGER and U.S. POINTER studies. Participants ages 60-77 with high risk of developing dementia will be randomized to a systemic lifestyle intervention or flexible lifestyle intervention.
For more information contact Lucia Crivelli.
South Korean Study to Prevent Cognitive Impairment and Protect Brain Health Through Lifestyle Intervention
The SoUth Korean study to PrEvent cognitive impaiRment and protect BRAIN health through lifestyle intervention in at-risk elderly people (SUPERBRAIN) consists of a feasibility randomized controlled trial (RCT) and a subsequent large-scale RCT for the multidomain intervention programs. The SUPERBRAIN programs have been developed with some modifications based on the FINGER study, which consists of a facility-based (FMI) and a home-based multidomain intervention (HMI) program suitable for elderly Koreans. The SUPERBRAIN programs include all five components of the intervention: (1) monitoring and management of metabolic and vascular risk factors; (2) cognitive training and social activity; (3) physical exercise; (4) nutritional guidance; and (5) motivational enhancement. The feasibility study aims to investigate the applicability of the SUPERBRAIN programs before a large-scale RCT to investigate the efficacy of the programs.
The feasibility study will recruit 150 participants from eight centers, among those without dementia aged 60-79 years with at least one modifiable dementia risk factor. Enrollment for the feasibility study began in May 2019. Participants will be randomly assigned at baseline in a 1-1-1 ratio to the FMI, HMI or control arms. Main secondary outcomes are disability, depressive symptoms, quality of life, vascular risk factors, physical performance, nutritional assessment, and motivation questionnaire. To investigate the mechanism by which the multidomain intervention program works in the brain, neurotrophic, neurodegeneration and neuroinflammation factors, gut microbiome, telomere length, electroencephalography and neuroimaging measures will be evaluated.
For more information contact Seong Hye Choi.
Multidomain Intervention for Reversal of Cognitive Frailty: Towards Personalized Approaches (My-AGELESS Trial)
The Centre for Healthy Aging and Wellness and Universiti Kebangsaan Malaysia (The National University of Malaysia, UKM), with the support from the Ministry of Education of Malaysia (MoE) Longterm Research Grant Scheme, have initiated efforts to adapt a version of the Finnish (FINGER) trial among a multiethnic Asian population in Malaysia. The My-AGELESS Trial is a 2-year clinical trial that will include screening of approximately 1,000 older persons who are at an increased risk of cognitive decline and physical frailty (cognitive frailty) from three different locations, urban, semi urban and rural areas of Malaysia. Following this study, 300 older adults at risk of cognitive frailty (CF) will be recruited in batches from December 2019 till November 2024 for the intervention. The main objective of this trial is to evaluate whether lifestyle interventions that simultaneously target many risk factors can reverse mild cognitive impairment and physical frailty. This trial will include substudies regarding gut microbiome.
My-AGELESS Trial is the first long term trial among Malaysian older persons, conducted over 24 months, involving renowned researchers from reputable academic institutions in Malaysia, including UKM, University Malaya (UM), University Technology Mara (UiTM), University Putra Malaysia (UPM) and University of Science Malaysia (USM). The key and novel deliverables include the understanding of physiological, environmental and psychosocial variabilities in response to the trial, leading to personalised rehabilitation medicine in reversing CF. The results of the trial will be used to develop a tele-rehabilitation module and its feasibility will be tested to empower trainers to deliver a community-based intervention in rural areas of Malaysia to prevent and reverse CF among older persons. Cost benefit and social impact of this trial will be captured for the interest of policy makers and stakeholders.
For more information contact Professor Dr. Suzana Shahar
The Taiwan Health Promotion Intervention Study for Elders
The Taiwan Health Promotion Intervention Study for Elders (THISCE) included two complementary lifestyle intervention-based clinical trials conducted in five cities in Taiwan, for the prevention of physical and cognitive decline for older adults (aged 65 and above) in the community.
The “Efficacy study” was a clinical intervention designed to promote physical and cognitive health of a group of 1,082 older adults over a period of a year. A group of participants in this trial performed physical exercises, underwent cognitive training and nutrition counseling, whereas the other group were given regular health education and advice. The other clinical trial called the “Empowerment study” evaluated the benefit of further empowering 440 participants over a nine-month period. This enhanced study replicated the same format of the first six months of the “Efficacy study.” However, their training sessions used new teaching materials that addressed feedback from the participants. This study also closely monitored participation by supporting the setting of goals based on post-curriculum feedback. Additionally, researchers encouraged greater participation of individuals in this study via group competitions, individual motivation and provided empowerment to the participants via community leader involvement.
Study results from both trials showed reduction in frailty and significantly improved aspects of physical, functional and cognitive performance, especially among participants aged 75 and older. Furthermore, the results from the “Efficacy study” also showed a 44% reduction in the risk of depression and a 55% decrease in the risk of malnutrition. These lifestyle interventions could help shape healthy aging policies in Taiwan and could potentially be scaled to other countries.
For more information contact Dr. Liang-Kung Chen.
BRAIN-Diabetes: Border Region Area Lifestyle Intervention Study for Healthy Neurocognitive Ageing in Diabetes
Researchers at Queens University Belfast, led by Peter Passmore, Claire McEvoy and Bernadette McGuinness, are investigating whether a multi-domain intervention (nutrition, exercise, cognitive stimulation and intensive vascular risk factor control) based on the FINGER study, is feasible and can protect cognition in older adults with Type 2 diabetes (DM) on the island of Ireland. The BRAIN-Diabetes study is funded by the EU's INTERREG VA program under the Cross-border Healthcare Intervention Trials In Ireland Network (CHITIN) partnership between the Public Health Agency in Northern Ireland, and the Health Research Board in the Republic of Ireland.
BRAIN-Diabetes aims to recruit 140 non-demented older adults (≥ 60 years) within 18 months of DM diagnosis. Participants randomized to control group will receive standard clinical care while those randomized to intensive intervention will receive a community-based multicomponent program involving a four-month active intervention followed by a two-month self-directed consolidation phase and a further three-month open phase. The protocol for BRAIN-diabetes was informed by qualitative research with the target population group.
BRAIN-Diabetes will use evidence-based quantitative and qualitative process evaluative measures to determine feasibility and fidelity of the intervention components as well as participant acceptability with the intervention and study procedures such as data collection methods. The overall goal of this study is to generate data to inform the design of a larger-scale trial to determine the therapeutic effect of a community-based lifestyle intervention on cognitive function in patients with Type 2 DM.
For more information contact Peter Passmore.
The Maximizing Technology and Methodology for Internet Prevention of Cognitive Decline: The Maintain Your Brain (MYB) trial (AUSTRALIA)
This ongoing randomized controlled trial addresses modifiable risk factors for dementia in general and AD in particular, physical inactivity, cognitive inactivity, depression/anxiety, overweight and obesity, and poor dietary habits. The trial aims to determine the efficacy of a multimodal targeted internet intervention to reduce the rate of cognitive decline in non-demented, community-dwelling people aged 55-77 years and in the long term to delay the onset of dementia. All assessments and interventions are conducted online, which if successful could provide a relatively low-cost strategy to deliver potentially preventative interventions at a population level and in particular to geographically-isolated people.
Participants (n = 6,236) have been randomized to receive a personalized multidomain intervention or non-interactive, web-based health advice and information. The four basic intervention modules are physical activity, computerized brain training, nutritional advice and cognitive behavior therapy for depression. Coaching is personalized for each participant and individuals are given 2-4 modules to complete based on their risk factor profile. Advice and helplines are provided regarding smoking cessation, reducing excess consumption of alcohol, and controlling blood pressure and cholesterol. Brain training includes a socialization component starting with internet buddies.
e-Health is key to helping people change their lifestyle and maintain these changes. As most people are internet connected, we can employ new state-of-the-art tools for internet and mobile device logging of behaviors, tracking of goal achievement, provision of feedback in real time, access to expert help lines and virtual and actual online trainers, and creation of an online MYB community to offer additional support.
For more information visit the Maintain Your Brain (MYB) website or contact Henry Brodaty or Megan Heffernan.
Prevention of Cognitive Decline After a Multimodal Intervention Combined with Epigallocatechin Gallate in APOE4 Carriers with Subjective Cognitive Decline: A Randomized Placebo Controlled Trial
PENSA (in Catalan means ‘think about’) is an ongoing trial in Barcelona, Spain that combines a multimodal lifestyle intervention including diet, physical activity, cognitive stimulation and training, combined with a dietary supplement of epigallocatechin gallate (the flavanol found in green tea). The study is enrolling 200 participants who meet the criteria of 60 years or older, APOE4 carriers, and who experience subjective cognitive decline — a self-reported measure of worsening memory loss and cognition. Participants will be randomized into one of four study arms with intervention lasting for 12 months with a 3 month follow up period. The primary outcome is the global cognitive composite (ADCS Preclinical Alzheimer Cognitive Composite-Plus-exe) and secondary outcomes include MRI and fMRI studies.
PENSA is performed in collaboration with the Hospital del Mar Medical Research Institute (IMIM) and the Barcelonabeta Brain Research Center (BBRC). The project is primarily funded by the Alzheimer's Association, with additional support from the Spanish Ministry of Science, Innovation and Universities (Instituto de Salud Carlos III).
For more information contact Rafael De La Torre or Jose Luis Molinuevo.
WW-FINGERS projects that are at various stages of development include:
EURO-FINGERS: A joint protocol is currently being developed to aid various European countries in establishing a FINGER-like study (EURO-FINGERS). Participating countries include the Netherlands, Spain, U.K., Italy and Sweden. Some new study design elements may be included (e.g., utilizing e-health and mobile-health (m-health) tools), tailoring interventions to take into account specific risk profiles, and combining a multidomain lifestyle-based intervention with pharmacological interventions.
CAN-Thumbs Up: The Canadian Therapeutics Platform Trial for Testing Interventions to Prevent Dementia (CAN-Thumbs Up) is in the planning stages and will enroll participants who have an increased risk for developing dementia. Participants will be randomized into one of three cohorts (1) provided education on brain health; (2) selected lifestyle interventions; and (3) selected pharmacological interventions.
The Japan-multimodal Intervention Trial for Prevention of Dementia (J-MINT) study is an 18-month multidomain intervention trial (open-label randomized controlled trial) aimed at reducing dementia in older adults with mild cognitive impairment between the ages of 65 and 85. The goals of this study are: 1) to clarify the effectiveness of the multidomain intervention program in reducing cognitive decline; 2) to clarify the mechanism of cognitive risk reduction using recent blood biomarkers and brain imaging analysis; and 3) to conduct research in collaboration with private companies, aiming at the future social implementation of new dementia prevention services.
J-MINT is a multicenter study in which the National Center for Geriatrics and Gerontology (NCGG) as the core institution is collaborating with Nagoya University, Nagoya City University, Fujita Health University, and Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology. The multidomain intervention program consists of management of lifestyle-related diseases, exercise guidance, nutritional guidance and cognitive training.
The study began enrollment in November 2019 and reached 531 participants in December 2020. The primary outcome will be the change in the composite score of cognitive function from the initial assessment to 18 months. Secondary outcomes will include the change in each neuropsychological test, the onset of dementia, the change in blood biomarkers, the change in brain morphology observed on brain MR imaging, the change in activities of daily living and frailty, and the number of drugs used.
In addition, the Japanese version of MoCA and CogEvo as simple indicators of cognitive function are also measured that will be available in future social implementation. These outcomes are assessed at the initial evaluation and at 6, 12 and 18 months.
The J-MINT study is supported by the Japan Agency for Medical Research and Development. For more information, contact Takashi Sakurai.