The MIND-AD trial

MIND-AD_mini was a 6-month multinational (Sweden, Finland, Germany, France) proof-of-concept randomised controlled trial. Participants were 60–85 years old, had very early (prodromal) Alzheimer’s disease and not-well managed vascular/lifestyle risk factors. The trial had three arms, where participants were randomly assigned: multidomain lifestyle intervention based on the FINGER model (nutritional guidance, exercise, cognitive training, vascular/metabolic risk management and social stimulation); multidomain lifestyle intervention+medical food (Fortasyn Connect); and regular health advice/care (control). The primary outcome was feasibility of the multidomain intervention, evaluated by recruitment rate during a 6-month recruitment phase, overall adherence in each intervention arm, and 6-month retention rate. Successful adherence was pre-specified as attending ≥40% of sessions/domain in≥2/4 domains (lifestyle intervention), and consuming ≥60% of the medical food (lifestyle intervention+medical food). The secondary outcomes included adherence/ participation to each intervention component and overall adherence to healthy lifestyle changes, measured using a composite score for healthy lifestyle. Cognitive and functional assessments were included as exploratory outcomes, using the Clinical Dementia Rating scale-Sum of boxes (CDR-SOB).

MIND-AD main results

A total of 93 individuals were randomised (32 lifestyle intervention group, 31 lifestyle+medical food, and 30 control group). Overall recruitment rate was 76.2% (64.8% during the first 6 months). Overall 6-month retention rate was 91.4% (lifestyle intervention 87.5%; lifestyle+medical food 90.3%; control 96.7%). Domain-specific adherence in the lifestyle intervention group was 71.9% to cognitive training, 78.1% exercise, 68.8% nutritional guidance, and 81.3% vascular risk management; and in the lifestyle+medical food group, 90.3% to cognitive training, 87.1% exercise, 80.7% nutritional guidance, 87.1% vascular risk management, and 87.1% medical food. Compared with control, both intervention arms showed improvements in terms of healthier diet. The lifestyle+medical food group also showed significant reduction of cardiovascular risk (P=0.043) and reduced rate of cognitive-functional decline (P<0.005), measured with CDR-SOB.

Risk reduction of Dementia: it is never too late!

MIND-AD_mini builds on the successful results and experience of the pioneering Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER,Lancet 2015), which earlier showed cognitive benefits from a multidomain lifestyle intervention in at-risk older people from the community. In parallel, the LipiDiDiet trial highlighted clinical benefits of medical food (Fortasyn Connect) in people with prodromal Alzheimer’s disease. However, the feasibility and impact of multidomain interventions combining lifestyle with medical food in prodromal Alzheimer’s disease has not been studied earlier.

“MIND-AD has been a natural next step to combine two successful approaches – non-pharmacological and medical food – and test their feasibility and potential synergy in people who already experience cognitive symptoms due to Alzheimer’s disease. The encouraging results of MIND-AD pave the way to design larger clinical trials investigating longer-term cognitive and other health benefits of combined non-pharmacological and pharmacological approaches.” says Professor Miia Kivipelto from Karolinska Institute and FINGERS Brain Health Institute, who led both MIND-AD and FINGER trials, the EU-FINGERS project and is the scientific leader of the World-Wide FINGERS network of multidomain trials for risk reduction of dementia.

Another newly published study in the Alzheimer’s Research and Therapy journal demonstrated positive effects of more intensive lifestyle changes in patients with mild cognitive impairment or early dementia due to Alzheimer’s disease. The clinical trial was led by Dr. Dean Ornish from the Preventive Medicine Research Institute and University of California, San Francisco, together with a team including Prof. Miia Kivipelto. The trial enrolled 51 participants for a 20 week intervention period, comparing an intensive multidomain lifestyle intervention with standard care approach. Main results indicated cognitive and functional benefits in the participants engaging in the multidomain intervention.

“These findings add to the growing body of evidence that moderate multimodal lifestyle changes may help reduce the risk of Alzheimer’s disease or slow its progression, and also suggest that more intensive multimodal lifestyle changes may have additional benefits for improving cognition in people with early Alzheimer’s disease”, pointed out Professor Alina Solomon from the Brain Research Unit at University of Eastern Finland, Scientific Coordinator for the MIND-ADmini trial.

Funding

MIND-AD trial was supported by the EU Joint Programme – Neurodegenerative Disease Research (JPND) and the following JPND projects EU-FINGERS and Multi-MeMo.

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Current research is hindered by unclear definitions and a lack of standardized measures to assess social activities, resulting in fragmented evidence about protective effects against dementia. Therefore, the authors call for questionnaires that accurately capture engagement in social activities and use them as a point of departure for intervention activities.

Randomized controlled trials, such as the FINGER trial, show that multidomain interventions—including nutrition guidance, physical exercise, cardiovascular management, and cognitive training—can reduce the risk of dementia. These interventions benefit older adults who are cognitively healthy, have mild cognitive impairment, or prodromal Alzheimer’s disease.

The authors suggest that incorporating social activities into these interventions can enhance both adherence and effectiveness. Based on interviews, they conclude that participants highly value social activities that increase feelings of social support. One participant stated, “We are a good group of friends, or have become [during the intervention]. We have fun, laugh, and we do our best”.

The authors also explore the potential of digital technologies, such as smartphones, Fitbits, and apps, which are increasingly used to deliver interventions. There is uncertainty about the effectiveness of these technologies in measuring or enhancing social activities. Based on a workshop hosted by Alzheimer Europe, involving individuals at risk of dementia and those with cognitive complaints or dementia, the authors recommend using simple tools that increase in-person contact and consider privacy.

In conclusion, the researchers call for more efforts to incorporate social activities into interventions to enhance cognitive health in aging populations. They aim to (a) develop clear definitions and instructions for measuring social activities, (b) promote social engagement beyond intervention settings, for instance through community participation, and (c) ensure technology and interventions are co-created to address older adults’ needs, enhancing rather than replacing in-person activities.

The authors are working in three different EU-funded projects: EU-FINGERS, Lethe and Multi-MeMo. They are: Bruinsma J, Visser LNC, Abaci A, Rosenberg A, Diaz A, Hanke S, Crutzen R, Mangialasche F, Kivipelto M, Thunborg, C.

Article link: https://www.frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2024.1386688/full

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The magazine features an article on the recent collaborative event for #PublicInvolvement in European brain health research, held in Luxembourg. The meeting involved six European research projects that joined together in a series of consultations. The first consultation gathered members of the EU FINGERS, LETHE and Multi-MeMo Advisory Boards who met for the very first time in person. (pages 14-17)

“I really like to tell the Advisory Board members that with their contributions they do not only make our project better but they make us better scientists.”

Mariagnese Barbera

A dedicated EU FINGERS article looks back at our innovative project and the achievements to date (pages 18-19). EU-FINGERS achieved several milestones: first and foremost, the consortium has grown with the inclusion of three research teams, from Hungary, Luxembourg and Spain, thus becoming even more representative of the European landscape and maximising the impact of this JPND-supported project. The expansion enriched availability of relevant data, with a total of about 2.000 participants from preventive trials and over 16.000 participants from observational studies on brain aging and Alzheimer’s disease. Secondly, the consortium developed tools supporting new intervention studies and the launch of two novel multidomain interventions (MET-FIN- GER, FINGER-NL). These innovative clinical trials are testing the FINGER updated life- style intervention with the drug metformin /MET-FINGER) or medical food (FINGER-NL). Finally, engagement of citizens has been achieved, establishing an Advisory Board which provided relevant input to carry on the consortium’s work.

“We have developed innovative tools, which open new avenues in the field of Alzheimer’s disease and dementia prevention, and we are testing them in pioneering trials.”

Miia Kivipelto

You can download the magazine here: https://bit.ly/DementiaInEurope44

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Several EU-FINGERS partners had the opportunity to travel to Lisbon and took part in inspiring discussions. The participation of the EU-FINGERS members showcased their wishes continuing to make significant strides towards understanding the complexities of Alzheimer’s disease and developing effective preventive strategies.

In a session dedicated to prediction and prevention of cognitive decline, our project coordinator Miia Kivipelto presented new data from FINGER-based trials related to efficacy, responders, adherence and biomarkers. An up-to-date status of the MET-FINGER and WW-FINGERS network was also presented.

Miia Kivipelto was invited as a panelist in the symposium hosted by Alzheimer’s Disease Data Initiative “How several key efforts are making their data and samples accessible to the broader research community”, moderated by Phyllis Ferrell.

“Dementia is a global challenge, and we need global solutions. Our answer to #dementia prevention is WW-FINGERS.”

“We have the mindset of data sharing when we started. But, not just data: experiences and learnings too on how to make data as useful and impactful as possible.”

Miia Kivipelto

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GOIZ ZAINDU (“caring early” in Basque) is a pilot study to adapt the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) methodology to the Basque population and evaluate the feasibility and adherence to a FINGER-like multidomain intervention program. Additional aims included the assessment of efficacy on cognition and data collection to design a large efficacy trial.

One hundred twenty-five participants were recruited (mean age: 75.64 (± 6.46); 58% women). The GOIZ ZAINDU pilot trial has shown that a multidomain lifestyle and risk factor monitoring intervention to prevent cognitive decline in older adults at a high risk of dementia is feasible and reproducible. This experience has successfully demonstrated that the FINGER trial methodology is adaptable to Southern European conditions, including diet, exercise habits, and the health care system

We would like to congratulate the whole GOIZ ZAINDU study team. The Basque team is led by Principal Investigator Pablo Martinez-Lage, with Mikel Tainta Cuezva as main researcher, both from Fundación CITA Alzhéimer.

You can read the open-access paper here: https://doi.org/10.1186/s13195-024-01393-z

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The first consultation held in 14 November gathered 17 members of the EU-FINGERS, LETHE and Multi-MeMo Advisory Boards who met for the very first time in person. Members came from nine European countries (Austria, Finland, Hungary, Italy, Luxembourg, Netherlands, Spain, Sweden, UK) to discuss topics around multidomain interventions to reduce dementia risk and communication tools for discussing risk of dementia with patients.

During this collaborative event, Alzheimer Europe took the opportunity to produce a series of video interviews. These interviews are with members of the Advisory Board members of the EU projects attending the meeting, researchers working on the project, the FNR programme manager and members of the European Working Group of People with Dementia (EWGPWD). They all shared their experiences working on the various projects and the vital contributions of the Advisory Boards ensuring that research accurately reflects the preferences, needs and priorities of members of the public and their perspectives in different aspects of research processes and outputs/results.

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The first consultation held in 14 November gathered 17 members of the EU-FINGERS, LETHE and Multi-MeMo Advisory Boards who met for the very first time in person. Members came from nine European countries (Austria, Finland, Hungary, Italy, Luxembourg, Netherlands, Spain, Sweden, UK) to discuss topics around multidomain interventions to reduce dementia risk and communication tools for discussing risk of dementia with patients. AE Project Officer Ana Diaz extended a warm welcome to all delegates, emphasised the importance of their presence and the pleasant spirit driving the meeting. Then, Sean Sapcariu provided valuable insights into the Luxembourg National Research Fund (FNR), the main funder of research activities in Luxembourg. Next, Francesca Mangialasche and Anna Rosenberg took the floor to provide a comprehensive update on the EU-FINGERS and LETHE projects. They reminded the aims and mission of each project and both emphasised the pivotal role of the Advisory Board members as essential partners to guide and influence relevant decisions on how the research activities are conducted.

The heart of the consultation unfolded through four workshops in small groups, facilitated by Anna Rosenberg, Leonie Visser, Tanja de Rijke and Heleen Hendriksen and co-facilitated by Francesca Mangialasche, Ana Diaz, Cindy Birck and Mariagnese Barbera. Members were engaged in dynamic discussions, exchanging thoughts and ideas on: 1) social activities in digital multi-domain interventions; 2) information needs on future Alzheimer’s disease medication; 3) a new tool to help patients and supporters to share personal information and 4) the implementation of tools to support preparation for memory clinic consultations.

Mariagnese Barbera concluded the event by presenting the overarching goals of the Multi-MeMo project and highlighting the continuity of Public Involvement work from EU-FINGERS to Multi-MeMo. The project partners would like to extend their heartfelt gratitude to all members of the Advisory Boards for their engagement, commitment and invaluable contributions.

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At this unprecedented event, taking place from 14 to 16 November, 44 members of the Advisory Boards of six EU-funded projects (EU-FINGERS, LETHE, Multi-MeMo, eBRAIN-Health, EPND and ADIS) all of which are working on different aspects of brain health and dementia research, will collaborate in a series of multi-project consultations. Members of these Advisory Boards, which are convened and moderated by Public Involvement leads at Alzheimer Europe, are people at a higher risk of, or living with, dementia, carers and supporters of people with dementia and other lay people with an interest in brain health and dementia prevention.

This will be the first collaborative meeting of this type and scale, uniting projects working on different aspects of brain health and dementia research, funded through the three largest research and innovation programmes in Europe: The Joint Programme on Neurodegenerative Diseases, Innovative Medicines Initiative, and Horizon Europe. The event will promote a collaborative approach to research and Public Involvement and will be an important opportunity for all of the projects represented, to share knowledge, experience, insights and ideas, with the aim of helping to move research forward, together.

The European Working Group of People with Dementia (EWGPWD) is involved in a number of projects through its work with Alzheimer Europe. Several members of the EWGPWD will travel to Luxembourg to participate in next week’s event. Some of them are also members of the Advisory Boards of these projects.

What is Public Involvement?
To ensure that research accurately reflects the preferences, needs and priorities of members of the public, their perspectives – including experiences and concerns – need to be included in different aspects of research processes and outputs/results. Public Involvement has been shown to improve the quality of research by enabling researchers to benefit from the lived experience of people with dementia but also other lay people (for example, people with Mild Cognitive Impairment (MCI), people at risk of developing MCI or dementia, carers/supporters of people with dementia). Public Involvement work helps ensure that research is ethical, transparent and gives people with dementia and other stakeholders with an interest in dementia research a voice, reflecting the principle of “nothing about us without us”.

What are Advisory Boards?
Advisory Boards are made up of lay people including, for example, people with Alzheimer’s disease or dementia, people with MCI, carers, and people at risk of developing MCI or dementia. These groups meet regularly to provide feedback and advice to researchers about various topics and issues linked to the research activities conducted by the project consortium.

Jean Georges, Executive Director, Alzheimer Europe, said:
“Alzheimer Europe is delighted and proud to host this important event, the first of its kind, and to champion the vital contributions that Advisory Boards are making to dementia and brain health research. Our organisation has been doing work in the area of Public Involvement, largely through our close collaboration with the European Working Group of People with Dementia, for many years (and, since 2022, with its new sister group, the European Dementia Carers Working Group). This work has made Alzheimer Europe a stronger organisation and has helped to steer our work in the right direction, by ensuring that people living with dementia and their carers/supporters have a voice. In recent years, we have extended our work in EU-funded research projects and it is truly fantastic to see the same principles applied and the same rewards reaped by researchers. Public Involvement helps shape better, more meaningful research outcomes and we hope this event will contribute towards moving research forwards but also highlight the importance of Public Involvement in research.”

Chris Roberts, Chairperson of the European Working Group of People with Dementia (EWGPWD), said:
“The EWGPWD is involved in several projects in which Alzheimer Europe is a partner. We receive lots of information and are extremely well supported about all projects, we are able to provide our perspectives and opinions to help ensure that the topics discussed are relevant to people with dementia. We also help to ensure that the way the research is conducted is appropriate and respectful to the participants who are living with dementia. It not only increases understanding, but helps enable researchers to adapt and revise their projects when new learning has taken place. Patient involvement can save time and money, as well as bringing valuable insight and advice to help guide the researchers in their work. Overall, the experience is very positive and mutually beneficial, it is really exciting to take part in this large-scale Public Involvement event in Luxembourg where we will at once contribute to multiple European research projects with our lived experiences.”

Francesca Mangialasche, Assistant Professor at Karolinska Institute (Stockholm, Sweden), coordinating centre for the EU-FINGERS project and a clinical partner of the LETHE project, said:
“The participation of Advisory Boards has been greatly beneficial for brain health research projects on many levels. This is also thanks to the ability of Alzheimer Europe to bring together clinicians, researchers and members of the public, facilitating meaningful involvement and communication.”

What will happen at this event?
On 14 November, members of the Advisory Boards from the EU-FINGERS, LETHE and Multi-MeMo projects will hold a consultation, discussing topics around multidomain interventions to reduce dementia risk and communication tools for discussing risk of dementia with patients.

On 15 November, members of the EWGPWD will be providing advice to the ADIS and EPND projects on matters related to consent and data-sharing in dementia research. The same topics will be addressed in Spanish with members of the ADIS Advisory Board on 16 November.

On 15 November, members of the eBRAIN-Health Advisory Boards will meet to test and provide their feedback on an app developed as part of the project and used for cognitive training and rehabilitation. They will also share their perspectives on the use of virtual reality tools in the context of brain health and dementia.

The event is funded by the Luxembourg National Research Fund (FNR) under the aegis of the EU Joint Programme – Neurodegenerative Disease Research (JPND), the European Union’s Horizon 2020 research and Innovation and the Innovative Medicines Initiative 2 Joint Undertaking (JU). The JU receives support from the European Union’s Horizon2020 research and innovation programme and the European Federation of Pharmaceutical Industries and Associations (EFPIA).

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A session entitled ““Precision prevention of Alzheimer´s disease and dementia: advancing multidomain interventions” was dedicated to the EU-FINGERS project. Miia Kivipelto (Karolinska Institutet, Sweden) project coordinator of EU-FINGERS moderated the session. First, Francesca Mangialasche (Karolinska Institutet, Sweden) gave an overview of the JPND-supported project, aiming at developing a novel methodology for precision prevention of Alzheimer´s disease and dementia, based on the successful experience of the multidomain, lifestyle-based Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER). Next, Mariagnese Barbera, (University of Eastern Finland, Finland) gave an update on MET-FINGER, which is the first trial combining a multimodal lifestyle intervention with a putative disease-modifying drug for cognitive decline prevention, named Metformin. Alara Abaci (Karolinska Institutet, Sweden) then presented the results of a study investigating the perspectives of memory clinic patients regarding research participation. Findings showed considerable variation in memory clinic patient perspectives regarding research participation, and identified facilitators and barriers for intervention trials. To close the session, Ana Diaz (Alzheimer Europe, Luxembourg) pointed out the importance of exploring and involving members of the public in brain health research and described the approach used to set up the EU-FINGERS Advisory Board as well as its impact on the project. Finally, Anna Rosenberg (Finnish Institute for Health and Welfare) and Petri Lampinen (Finnish EU-FINGERS Advisory Board member) shared both their views on the EU-FINGERS Advisory Board, which provides feedback and advice to the EU-FINGERS researchers about various topics and issues linked to the research activities conducted by the consortium.

In addition to the EU-FINGERS session, Miia Kivipelto was the first speaker of the second plenary of the conference on “Brain health and prevention”, discussing “Building the evidence base for multi-modal interventions through European and International collaborations”.  She said that risk reduction of cognitive impairment and dementia is possible and indeed is already happening. Brain health, she stressed, should be a priority for society.  With an increasing body of evidence from clinical trials to show that multidomain interventions targeting several risk factors are effective and feasible, the EU-FINGERS and World-Wide FINGERS networks are now working on further developing and adapting these interventions to different target populations and settings.

We were glad that several members of the EU-FINGERS Advisory Board were in attendance and were able to join on-site and online.

More information about EU-FINGERS’s work can be found in the recently supplement published with new Dementia in Europe magazine at 33rd Alzheimer Europe Conference here.

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The supplement starts with a general description of the project. Miia Kivipelto, the project leader, shares the vision behind the project and her enthusiasm for this important topic. After that, you will get an overview of the tools and methods the group has been developed in the area of brain health and prevention of Alzheimer’s dementia. Prevention and risk reduction of Alzheimer’s disease and dementia are relatively new research areas, which are rapidly growing. This research field can greatly benefit from input from the general public, people with an interest in the topic and people experiencing cognitive problems or living with early-stage dementia. The supplement also includes a section on how the EU-FINGERS Advisory Board was build and how it brings a unique perspective and actively and meaningfully contribute towards several aspects of the project.

You can download the EU-FINGERS supplement, here: https://www.alzheimer-europe.org/sites/default/files/2023-10/dementia_in_europe_magazine_issue_43_october_2023_-_eu_fingers_supplement.pdf

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