Cognitive ImpairmentLETHENCT05565170
Digitally Supported Lifestyle Programme to Promote Brain Health Among Older Adults
A study testing Structured ICT-assisted multimodal lifestyle intervention and Self-guided multimodal lifestyle intervention in people with Cognitive Impairment and Cognitive Decline, run by Finnish Institute for Health and Welfare at 4 sites in 4 countries.
Trial summary
Previous research has shown that a healthy lifestyle, including a balanced diet, physical and social activity, and management of vascular risk factors can support both cardiovascular and brain health. Read more about this study
- Who is it for?
- Ages 60 to 77 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Impairment, Cognitive Decline, Dementia
- What is being tested?
- Structured ICT-assisted multimodal lifestyle intervention and Self-guided multimodal lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 30 Jan 2023to 2 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 77 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 60-77 years
- Cardiovascular Risk Factors, Aging and Incidence of Dementia (CAIDE) Risk Score ≥ 6 points
- Cognitive performance at the mean level or slightly lower than expected for age, assessed with Mini-Mental State Examination (MMSE) and the Consortium to Establish a registry for Alzheimer's Disease (CERAD) verbal learning test (word list learning/recall)
- Proficiency in the local language (German, Italian, Finnish or Swedish)
- Ability and willingness to use an Android smartphone, access to and ability to use the internet (digital readiness)
- Existing compatible smartphone (Android) or willingness to use a new Android smartphone provided from the study
Who cannot join
- Dementia or substantial cognitive impairment (e.g., memory clinic referral needed as judged by the study physician)
- Current or past use of medications for Alzheimer's disease or related diseases (e.g., cholinesterase inhibitors, memantine)
- Diminished decision-making capacity, not capable of consenting or completing study assessments, based on clinical judgement
- Other significant neurologic disease, including but not limited to Parkinson's disease, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma with persistent neurologic sequelae or known structural brain abnormalities
- Any condition affecting safe engagement in the intervention, e.g., malignant disease, major depression, symptomatic cardiovascular disease, revascularisation within 1 year previously
- Severe loss of vision, hearing, or communicative ability; conditions preventing cooperation as judged by the study physician
- Concomitant participation in an interventional trial (unless this will not interfere with the LETHE trial based on study staff's judgement)
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
Official title: Digitally Supported Lifestyle Programme to Promote Brain Health Among Older Adults - the LETHE Pilot Trial
Previous research has shown that a healthy lifestyle, including a balanced diet, physical and social activity, and management of vascular risk factors can support both cardiovascular and brain health. In a landmark Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER), a multimodal lifestyle programme had clear benefits on older adults' cognition, functioning, and quality of life. The LETHE study utilises novel technologies and digital tools to deliver an optimised and more personalised FINGER-type multimodal lifestyle intervention.
A total of 160 digitally skilled older adults (age 60-77) with risk factors for dementia but without substantial cognitive impairment will be recruited in Austria, Finland, Italy, and Sweden. Participants will be randomly assigned in a 1:1 ratio to the structured ICT-assisted multimodal lifestyle program (intervention group) or a self-guided lifestyle program (control group). Duration of the study and the intervention is 24 months. The multimodal lifestyle program covers the following domains: physical activity, nutrition, cognitive activity, vascular risk management, social interaction, sleep, and relaxation. The structured intervention program follows a hybrid model where regular in-person, individual and group-based intervention activities led by professionals are supported with activities in the LETHE mobile phone application. The self-guided (control) group receives relevant health advice and is recommended and encouraged to independently implement healthy lifestyle changes that are suitable and fit in with their daily routine. Control group will have access to a simplified version of the LETHE app without any structured, scheduled activities or personalized content.
The primary objective of the LETHE trial is to test the feasibility of a digitally supported multimodal lifestyle program (i.e., retention rate, adherence to intervention), and assess change in dementia risk based on validated risk scores (CAIDE, LIBRA). Other objectives include testing the intervention effects on lifestyle and risk factors, cognition, function, health-related quality of life, health literacy, physical functioning, and dementia-related biomarkers. To this aim, a range of personal, lifestyle, and health-related data will be collected both actively and passively with the help of digital devices. Attitudes towards digital tools and experiences of trial participation will also be explored.
Read the detailed description
The LETHE pilot trial is a 24-month multicentre parallel-group randomised controlled trial conducted in Finland (Finnish Institute for Health and Welfare, THL), Austria (Medical University of Vienna, MUW), Sweden (Karolinska Institute, KI), and Italy (University of Perugia, UPG). LETHE is an academic-led trial (funded by EU Commission) where all four clinical centers are jointly and equally responsible for the planning and conduct of the trial.
The recruitment goal is 160 participants (40 per country). Participants will be recruited e.g., through public announcements or advertisements (newspaper, social media) and at the local study centres. Interested individuals will first be pre-screened to check the key inclusion criteria related to e.g., age, digital skills and readiness, and risk factor profile (CAIDE dementia risk score). Persons who appear to meet the inclusion criteria (and no reasons for exclusion have arisen) are then invited for the actual screening assessment visit (organised remotely or in-person) where the eligibility criteria are checked in detail (including cognition). Exclusion criteria are assessed by a physician (for those who meet the inclusion criteria). Eligible individuals are invited to the baseline visit at the study centre. After completing all baseline assessments, participants are randomised in 1:1 ratio to the intervention group (structured ICT-assisted multimodal lifestyle intervention) and control group (self-guided multimodal lifestyle intervention). Randomisation will be balanced across sites.
At the beginning of the study, all participants receive an Android smartphone (unless they have already a compatible phone which they prefer to use), first with a simplified version of the LETHE App installed where participants can complete a set of outcome assessment questionnaires (e.g., lifestyle-related). After randomisation, a visit is booked to hand out the Fitbit smartwatch (different versions for the intervention and control groups) and install the full study version of the App (also different for the different groups). The App and the smartwatch are used for both active and passive data collection throughout the trial, and to support the intervention delivery. The intervention group will be offered a structured and tailored multimodal lifestyle programme (based on the FINGER model) including regular in-person (face-to-face and remote) counselling and sessions led by professionals, as well as independent digital activities in the LETHE App. Sessions and activities are related to the following intervention components: physical activity, nutrition, cognitive activity, vascular risk management and monitoring, social interaction, sleep, and relaxation/stress management. Recommendations and plans are tailored. The LETHE App, which has been designed by the LETHE consortium for this project, has features such as e.g., a cognitive training program, on-demand exercise videos, calendar to schedule activities, advice and educational material, group chat, and possibility to set and monitor goals and self-monitor risk factors such as e.g., blood pressure. Participants in the self-guided group are instructed to build their own lifestyle programme based on general health and lifestyle recommendations that they will receive at the main study visits. They will also have access to a simplified version of the LETHE App with static educational content about healthy lifestyle, but without any structured and scheduled activities, interactive features, or personalised content.
After baseline, all participants are invited to the study centre for three main study visits to collect outcome information, at month 6, 12, and 24. The outcome assessors are blinded to the group allocation and participants are not actively told to which group they were assigned. Data collection through the digital devices takes place continuously. The primary objective of the trial is to assess the feasibility of the digitally supported multimodal lifestyle intervention programme, i.e., assess retention rate (what proportion of participants completes the 24-month intervention period) and adherence to the intervention and engagement with the digital tools. Furthermore, changes in validated dementia risk scores (CAIDE, LIBRA) are assessed. Other objectives include testing the intervention effects on lifestyle and different risk factors of cognitive decline and dementia, cognitive performance, physical functioning, health-related quality of life, health literacy, and dementia-related fluid and imaging biomarkers. Participants' experiences of study participation and views on e.g., the usability and acceptability of the digital tools will also be explored (through interviews/focus groups).
- Conditions
- Cognitive Impairment, Cognitive Decline, Dementia
- Being tested
- Structured ICT-assisted multimodal lifestyle intervention, Self-guided multimodal lifestyle intervention
- Keywords
- Prevention, Risk reduction, Brain health, Lifestyle intervention, Digital intervention, eHealth, Telemedicine
- Medical subject headings
- Cognitive Dysfunction, Dementia, Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured ICT-assisted multimodal lifestyle interventionBehavioural
The structured lifestyle intervention programme, partly tailored and personalised to individual needs, covers the following domains: physical activity, nutrition, cognitive activity, cardiovascular risk management, social interaction, sleep, and relaxation / stress management. The programme includes regular scheduled in-person sessions (group-based + individual) which are supported with independent digital activities in the LETHE App. The App has features such as e.g., a cognitive training programme, on-demand exercise videos, calendar to schedule activities, advice and educational material, group chat, and possibility to set and monitor goals and self-monitor risk factors such as e.g., blood pressure.
Self-guided multimodal lifestyle interventionBehavioural
Participants are advised to build their own healthy lifestyle programme based on standard healthy lifestyle advice that they will receive at individual consultations with the study physician/nurse as part of the study visits and through the simplified version of the LETHE app. The control group app does not include any structured / scheduled activities or personalised content.
| Study group | Role | What they receive |
|---|---|---|
| Structured ICT-assisted multimodal lifestyle intervention | Active comparator | Participants assigned to this study arm follow an intensive structured, digitally supported multimodal lifestyle intervention programme (combination of individual and group-based in-person consultations/sessions and digital activities in the LETHE mobile phone App). Intervention duration is 2 years. Receives: Behavioral: Structured ICT-assisted multimodal lifestyle intervention |
| Self-guided multimodal lifestyle intervention | Sham comparator | Participants assigned to this study arm receive regular health advice in connection with the study visits (and through a simplified version of the LETHE mobile phone App), and are recommended and encouraged to independently implement healthy lifestyle changes that are suitable and fit in with their daily routine. Intervention duration is 2 years. Receives: Behavioral: Self-guided multimodal lifestyle intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: retention rate
Percentage of participants completing the 24-month trial period in each study arm. Higher percentage indicates a better outcome.
Measured: 24 months
Feasibility: adherence to the structured multimodal lifestyle intervention
Attendance at scheduled intervention sessions (percentage), usage of / engagement with the digital devices (LETHE App, Fitbit smartwatch). Possible values range from a minimum of 0, with higher values indicating better adherence and more active engagement.
Measured: Continuously measured during 24 months
Change in dementia risk scores (LIBRA and CAIDE), units on a scale
Cardiovascular Risk Factors, Aging, and Incidence of Dementia (CAIDE) risk score and Change in the LIfestyle for BRAin health (LIBRA) score are validated tools to estimate late-life dementia risk based on a combination of non-modifiable and modifiable risk factors (CAIDE) or modifiable factors only (LIBRA). Total score ranges from 0 to 15 (CAIDE) and from -5.9 to +12.7 (LIBRA). Higher scores indicate higher risk.
Measured: Baseline, 12 months, 24 months
Secondary outcomes (6)
Change in healthy lifestyle, unit on a scale
Change in Healthy Lifestyle Index (brief score developed in the FINGER trial), a composite score based on self-reported data on exercise, diet, vascular factors, and cognitive/social activity (range 0-24, with a higher score indicating a better outcome)
Measured: Baseline, 12 months, 24 months
Change in cognition: composite z-score based on an extended Neuropsychological Test Battery (NTB), unit on a scale
The NTB used in this study is adapted from the FINGER trial and includes the following tests:
- Wechsler Memory Scale Revised, WMS-III, WMS-R, logical memory, immediate
- WMS-R logical memory, delayed
- WMS-R visual paired associates, immediate
- WMS-R visual paired associates, delayed
- WMS-R Digit Span, total
- Rey Auditory Verbal Learning Test, RAVLT, learning (free recall)
- RAVLT, delayed recall
- CERAD category fluency
- Category fluency (fruits and vegetables)
- Trail Making Test (TMT) A
- Trail Making Test (TMT) B, shifting score B-A
- Stroop Test, shortened 40-stimulus version, condition 2
- Stroop Test, condition 3, interference score 3 - 2
- Wechsler Adult Intelligence Scale (WAIS) Digit Symbol Substitution Test (DSST)
Higher z-score indicates better outcome (better cognitive performance).
Measured: Baseline, 12 months, 24 months
Change in stress-related symptoms (Perceived Stress Scale, PSS-14), unit on a scale
PSS is a 14-item self-report scale assessing stress-related symptoms. Values ranging 0-56, with lower scores indicating a better outcome.
Measured: Baseline, 12 months, 24 months
Change in sleep problems (Insomnia Severity Index, ISI), unit on a scale
The Insomnia Severity Index (ISI) is a validated seven item assessment tool to assist in the clinical evaluation of insomnia complaints. Values ranging 0-28, with lower scores indicating a better outcome.
Measured: Baseline, 12 months, 24 months
Change in health-related quality of life (RAND-36), unit on a scale
The RAND-36 is comprised of 36 items that assess eight health concepts. The scale values are ranging 0-100, with higher scores indicating a better outcome.
Measured: Baseline, 12 months, 24 months
Change in health literacy (short version of the European Health Literacy Survey Questionnaire, HLS-EU-Q16), unit on a scale.
Health literacy will be assessed with the 16-item short version of the European Health Literacy Survey Questionnaire. Each item has four response categories (very difficult, fairly difficult, fairly easy and very easy), and higher scores indicate better health literacy.
Measured: Baseline, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start30 Jan 2023
- Primary completion12 May 2025
- Study completion2 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomised 1:1 to two parallel arms: * structured ICT-assisted multimodal lifestyle intervention (intervention group) * self-guided multimodal lifestyle intervention (control group)
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Finnish Institute for Health and Welfare
- Sponsor type
- Other government
- Collaborators
- Medical University of Vienna, Karolinska Institutet, University Of Perugia, FH Joanneum Gesellschaft mbH, Foundation for Research and Technology - Hellas (FORTH), Infotrend Innovations Co Ltd, Innovation To Grow, Kaasa solution GmbH, Lisbon Council, Maastricht University, Combinostics Oy, Alzheimer Europe, Extra Red s.r.l., Stichting EGI
- Responsible party
- Sponsor
- Investigators
- Tiia Ngandu, MD PhD, Principal investigator, Finnish Institute for Health and WelfareElisabeth Stögmann, MD PhD, Principal investigator, Medical University of ViennaFrancesca Mangialasche, MD PhD, Principal investigator, Karolinska InstitutetPatrizia Mecocci, MD PhD, Principal investigator, University Of Perugia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05565170
- Sponsor's protocol ID
- 101017405
- Acronym
- LETHE
- Status last verified
- May 2026
- First submitted
- 26 Sep 2022
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The LETHE consortium is open to requests from external researchers for data collected in this study. Applicants will be asked to submit a study protocol, including the research question, planned analysis, and data required. Data controllers will evaluate this plan (i.e., relevance of the research question, suitability of data, quality of proposed analyses, planned/ongoing LETHE analyses, and other matters) on a case-by-case basis and provide the data or reject the request. Shared data will encompass the data dictionary and de-identified data only. Any analysis will be conducted in collaboration with the LETHE Group. Access is subject to the LETHE legal framework. An access agreement will be prepared and signed by relevant parties.
Publications
Rosenberg A, Untersteiner H, Guazzarini AG, Bodenler M, Bruinsma J, Buchgraber-Schnalzer B, Colombo M, Crutzen R, Diaz A, Fotiadis DI, Hilberger H, Huber S, Kaartinen N, Kassiotis T, Kivipelto M, Lehtisalo J, Loukas VS, Lotjonen J, Pirani M, Thunborg C, Hanke S, Mangialasche F, Mecocci P, Stogmann E, Ngandu T; on behaf of the LETHE Consortium. A digitally supported multimodal lifestyle program to promote brain health among older adults (the LETHE randomized controlled feasibility trial): study design, progress, and first results. Alzheimers Res Ther. 2024 Nov 21;16(1):252. doi: 10.1186/s13195-024-01615-4.
PubMed 39574193
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digitally Supported Lifestyle Programme to Promote Brain Health Among Older Adults - the LETHE Pilot Trial
- ClinicalTrials.gov ID
- NCT05565170
- Acronym / sponsor ID
- LETHE / 101017405
- Conditions
- Cognitive Impairment, Cognitive Decline, Dementia
- Keywords
- Prevention, Risk reduction, Brain health, Lifestyle intervention, Digital intervention, eHealth, Telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Finnish Institute for Health and WelfareOther government
- Collaborators
- Medical University of Vienna, Karolinska Institutet, University Of Perugia, FH Joanneum Gesellschaft mbH, Foundation for Research and Technology - Hellas (FORTH), Infotrend Innovations Co Ltd, Innovation To Grow, Kaasa solution GmbH, Lisbon Council, Maastricht University, Combinostics Oy, Alzheimer Europe, Extra Red s.r.l., Stichting EGI
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 12 May 2025 (actual)
- Study completion
- 2 Jul 2025 (actual)
- First posted
- 4 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Previous research has shown that a healthy lifestyle, including a balanced diet, physical and social activity, and management of vascular risk factors can support both cardiovascular and brain health. In a landmark Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER), a multimodal lifestyle programme had clear benefits on older adults' cognition, functioning, and quality of life. The LETHE study utilises novel technologies and digital tools to deliver an optimised and more personalised FINGER-type multimodal lifestyle intervention.
A total of 160 digitally skilled older adults (age 60-77) with risk factors for dementia but without substantial cognitive impairment will be recruited in Austria, Finland, Italy, and Sweden. Participants will be randomly assigned in a 1:1 ratio to the structured ICT-assisted multimodal lifestyle program (intervention group) or a self-guided lifestyle program (control group). Duration of the study and the intervention is 24 months. The multimodal lifestyle program covers the following domains: physical activity, nutrition, cognitive activity, vascular risk management, social interaction, sleep, and relaxation. The structured intervention program follows a hybrid model where regular in-person, individual and group-based intervention activities led by professionals are supported with activities in the LETHE mobile phone application. The self-guided (control) group receives relevant health advice and is recommended and encouraged to independently implement healthy lifestyle changes that are suitable and fit in with their daily routine. Control group will have access to a simplified version of the LETHE app without any structured, scheduled activities or personalized content.
The primary objective of the LETHE trial is to test the feasibility of a digitally supported multimodal lifestyle program (i.e., retention rate, adherence to intervention), and assess change in dementia risk based on validated risk scores (CAIDE, LIBRA). Other objectives include testing the intervention effects on lifestyle and risk factors, cognition, function, health-related quality of life, health literacy, physical functioning, and dementia-related biomarkers. To this aim, a range of personal, lifestyle, and health-related data will be collected both actively and passively with the help of digital devices. Attitudes towards digital tools and experiences of trial participation will also be explored.
Detailed description
The LETHE pilot trial is a 24-month multicentre parallel-group randomised controlled trial conducted in Finland (Finnish Institute for Health and Welfare, THL), Austria (Medical University of Vienna, MUW), Sweden (Karolinska Institute, KI), and Italy (University of Perugia, UPG). LETHE is an academic-led trial (funded by EU Commission) where all four clinical centers are jointly and equally responsible for the planning and conduct of the trial.
The recruitment goal is 160 participants (40 per country). Participants will be recruited e.g., through public announcements or advertisements (newspaper, social media) and at the local study centres. Interested individuals will first be pre-screened to check the key inclusion criteria related to e.g., age, digital skills and readiness, and risk factor profile (CAIDE dementia risk score). Persons who appear to meet the inclusion criteria (and no reasons for exclusion have arisen) are then invited for the actual screening assessment visit (organised remotely or in-person) where the eligibility criteria are checked in detail (including cognition). Exclusion criteria are assessed by a physician (for those who meet the inclusion criteria). Eligible individuals are invited to the baseline visit at the study centre. After completing all baseline assessments, participants are randomised in 1:1 ratio to the intervention group (structured ICT-assisted multimodal lifestyle intervention) and control group (self-guided multimodal lifestyle intervention). Randomisation will be balanced across sites.
At the beginning of the study, all participants receive an Android smartphone (unless they have already a compatible phone which they prefer to use), first with a simplified version of the LETHE App installed where participants can complete a set of outcome assessment questionnaires (e.g., lifestyle-related). After randomisation, a visit is booked to hand out the Fitbit smartwatch (different versions for the intervention and control groups) and install the full study version of the App (also different for the different groups). The App and the smartwatch are used for both active and passive data collection throughout the trial, and to support the intervention delivery. The intervention group will be offered a structured and tailored multimodal lifestyle programme (based on the FINGER model) including regular in-person (face-to-face and remote) counselling and sessions led by professionals, as well as independent digital activities in the LETHE App. Sessions and activities are related to the following intervention components: physical activity, nutrition, cognitive activity, vascular risk management and monitoring, social interaction, sleep, and relaxation/stress management. Recommendations and plans are tailored. The LETHE App, which has been designed by the LETHE consortium for this project, has features such as e.g., a cognitive training program, on-demand exercise videos, calendar to schedule activities, advice and educational material, group chat, and possibility to set and monitor goals and self-monitor risk factors such as e.g., blood pressure. Participants in the self-guided group are instructed to build their own lifestyle programme based on general health and lifestyle recommendations that they will receive at the main study visits. They will also have access to a simplified version of the LETHE App with static educational content about healthy lifestyle, but without any structured and scheduled activities, interactive features, or personalised content.
After baseline, all participants are invited to the study centre for three main study visits to collect outcome information, at month 6, 12, and 24. The outcome assessors are blinded to the group allocation and participants are not actively told to which group they were assigned. Data collection through the digital devices takes place continuously. The primary objective of the trial is to assess the feasibility of the digitally supported multimodal lifestyle intervention programme, i.e., assess retention rate (what proportion of participants completes the 24-month intervention period) and adherence to the intervention and engagement with the digital tools. Furthermore, changes in validated dementia risk scores (CAIDE, LIBRA) are assessed. Other objectives include testing the intervention effects on lifestyle and different risk factors of cognitive decline and dementia, cognitive performance, physical functioning, health-related quality of life, health literacy, and dementia-related fluid and imaging biomarkers. Participants' experiences of study participation and views on e.g., the usability and acceptability of the digital tools will also be explored (through interviews/focus groups).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomised 1:1 to two parallel arms: * structured ICT-assisted multimodal lifestyle intervention (intervention group) * self-guided multimodal lifestyle intervention (control group)
| Arm | Type | Receives |
|---|---|---|
| Structured ICT-assisted multimodal lifestyle intervention | Active comparator | Behavioral: Structured ICT-assisted multimodal lifestyle interventionParticipants assigned to this study arm follow an intensive structured, digitally supported multimodal lifestyle intervention programme (combination of individual and group-based in-person consultations/sessions and digital activities in the LETHE mobile phone App). Intervention duration is 2 years. |
| Self-guided multimodal lifestyle intervention | Sham comparator | Behavioral: Self-guided multimodal lifestyle interventionParticipants assigned to this study arm receive regular health advice in connection with the study visits (and through a simplified version of the LETHE mobile phone App), and are recommended and encouraged to independently implement healthy lifestyle changes that are suitable and fit in with their daily routine. Intervention duration is 2 years. |
Who may qualify
- Ages
- 60 to 77 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 60-77 years
- Cardiovascular Risk Factors, Aging and Incidence of Dementia (CAIDE) Risk Score ≥ 6 points
- Cognitive performance at the mean level or slightly lower than expected for age, assessed with Mini-Mental State Examination (MMSE) and the Consortium to Establish a registry for Alzheimer's Disease (CERAD) verbal learning test (word list learning/recall)
- Proficiency in the local language (German, Italian, Finnish or Swedish)
- Ability and willingness to use an Android smartphone, access to and ability to use the internet (digital readiness)
Key exclusion criteria (7 listed)
- Dementia or substantial cognitive impairment (e.g., memory clinic referral needed as judged by the study physician)
- Current or past use of medications for Alzheimer's disease or related diseases (e.g., cholinesterase inhibitors, memantine)
- Diminished decision-making capacity, not capable of consenting or completing study assessments, based on clinical judgement
- Other significant neurologic disease, including but not limited to Parkinson's disease, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma with persistent neurologic sequelae or known structural brain abnormalities
- Any condition affecting safe engagement in the intervention, e.g., malignant disease, major depression, symptomatic cardiovascular disease, revascularisation within 1 year previously
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured ICT-assisted multimodal lifestyle interventionThe structured lifestyle intervention programme, partly tailored and personalised to individual needs, covers the following domains: physical activity, nutrition, cognitive activity, cardiovascular risk management, social interaction, sleep, and relaxation / stress management. The programme includes regular scheduled in-person sessions (group-based + individual) which are supported with independent digital activities in the LETHE App. The App has features such as e.g., a cognitive training programme, on-demand exercise videos, calendar to schedule activities, advice and educational material, group chat, and possibility to set and monitor goals and self-monitor risk factors such as e.g., blood pressure. | Behavioural | Structured ICT-assisted multimodal lifestyle intervention |
| Self-guided multimodal lifestyle interventionParticipants are advised to build their own healthy lifestyle programme based on standard healthy lifestyle advice that they will receive at individual consultations with the study physician/nurse as part of the study visits and through the simplified version of the LETHE app. The control group app does not include any structured / scheduled activities or personalised content. | Behavioural | Self-guided multimodal lifestyle intervention |
Primary outcome
Feasibility: retention rate
Time frame: 24 months
Percentage of participants completing the 24-month trial period in each study arm. Higher percentage indicates a better outcome.
Feasibility: adherence to the structured multimodal lifestyle intervention
Time frame: Continuously measured during 24 months
Attendance at scheduled intervention sessions (percentage), usage of / engagement with the digital devices (LETHE App, Fitbit smartwatch). Possible values range from a minimum of 0, with higher values indicating better adherence and more active engagement.
Change in dementia risk scores (LIBRA and CAIDE), units on a scale
Time frame: Baseline, 12 months, 24 months
Cardiovascular Risk Factors, Aging, and Incidence of Dementia (CAIDE) risk score and Change in the LIfestyle for BRAin health (LIBRA) score are validated tools to estimate late-life dementia risk based on a combination of non-modifiable and modifiable risk factors (CAIDE) or modifiable factors only (LIBRA). Total score ranges from 0 to 15 (CAIDE) and from -5.9 to +12.7 (LIBRA). Higher scores indicate higher risk.
6 secondary outcomes
Change in healthy lifestyle, unit on a scale
Time frame: Baseline, 12 months, 24 months
Change in cognition: composite z-score based on an extended Neuropsychological Test Battery (NTB), unit on a scale
Time frame: Baseline, 12 months, 24 months
Change in stress-related symptoms (Perceived Stress Scale, PSS-14), unit on a scale
Time frame: Baseline, 12 months, 24 months
Change in sleep problems (Insomnia Severity Index, ISI), unit on a scale
Time frame: Baseline, 12 months, 24 months
Change in health-related quality of life (RAND-36), unit on a scale
Time frame: Baseline, 12 months, 24 months
Change in health literacy (short version of the European Health Literacy Survey Questionnaire, HLS-EU-Q16), unit on a scale.
Time frame: Baseline, 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Results publication: PubMed 39574193Rosenberg A, Untersteiner H, Guazzarini AG, Bodenler M, Bruinsma J, Buchgraber-Schnalzer B, Colombo M, Crutzen R, Diaz A, Fotiadis DI, Hilberger H, Huber S, Kaartinen N, Kassiotis T, Kivipelto M, Lehtisalo J, Loukas VS, Lotjonen J, Pirani M, Thunborg C, Hanke S, Mangialasche F, Mecocci P, Stogmann E, Ngandu T; on behaf of the LETHE Consortium. A digitally supported multimodal lifestyle program to promote brain health among older adults (the LETHE randomized controlled feasibility trial): study design, progress, and first results. Alzheimers Res Ther. 2024 Nov 21;16(1):252. doi: 10.1186/s13195-024-01615-4.
- Individual participant dataSharing planned: Yes. The LETHE consortium is open to requests from external researchers for data collected in this study. Applicants will be asked to submit a study protocol, including the research question, planned analysis, and data required. Data controllers will evaluate this plan (i.e., relevance of the research question, suitability of data, quality of proposed analyses, planned/ongoing LETHE analyses, and other matters) on a case-by-case basis and provide the data or reject the request. Shared data will encompass the data dictionary and de-identified data only. Any analysis will be conducted in collaboration with the LETHE Group. Access is subject to the LETHE legal framework. An access agreement will be prepared and signed by relevant parties.
Related trials for Cognitive Impairment
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Recruiting
HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms
Alzheimer Disease, Dementia
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
Community-based Screening for Alzheimer's Disease
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tiia Ngandu, MD PhD principal investigator
Finnish Institute for Health and Welfare
Elisabeth Stögmann, MD PhD principal investigator
Medical University of Vienna
Francesca Mangialasche, MD PhD principal investigator
Karolinska Institutet
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured ICT-assisted multimodal lifestyle intervention and Self-guided multimodal lifestyle intervention in people with Cognitive Impairment and Cognitive Decline, run by Finnish Institute for Health and Welfare at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Austria, Finland, Italy, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: retention rate (time frame: 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05565170, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.