Lifestyle InterventionLIGHTNCT06832761
Lifestyle Intervention in the Memory Clinics of General and Academic Hospitals Trial
A study testing Personalized lifestyle intervention in people with Lifestyle Intervention and Lifestyle Risk Reduction, run by Maastricht University Medical Center at 2 sites in Netherlands.
Trial summary
Lifestyle Intervention in the memory clinics of General and academic Hospitals Trial (LIGHT) is a multi-center, randomized, controlled, lifestyle intervention trial among 300 older adults (≥50 years) with subjective cognitive decline (SCD) and mild cognitive impairment (MCI) at risk of dementia. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Lifestyle Intervention, Lifestyle Risk Reduction, Cognitive Decline
- What is being tested?
- Personalized lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesNetherlands
- Study dates
- 27 Jan 2025to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥50 years of age at pre-screening;
- Having a diagnosis of SCD or MCI;
- Presence of ≥ 2 modifiable risk factors for dementia.
Who cannot join
- Having a diagnosis of dementia;
- Insufficient understanding of the Dutch language;
- Conditions affecting safe and continuous engagement in the intervention (e.g. under treatment for current malignant diseases, major psychiatric disorders (e.g. major depression, psychosis, bipolar disorder), other conditions preventing co-operation as judged by the local study nurse or consulted physician at the local study site;
- Participation in any other research intervention trial at time of pre-screening and throughout the study period.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands2 sites, 1 recruiting
- Completed
Alzheimer Center Amsterdam
Amsterdam
- Recruiting
Maastricht University
Maastricht
Veerle Van Gils, PhD, +316-14348188, v.vangils@maastrichtuniversity.nl
Sebastian Köhler, Professor
About this study
Official title: Secondary Prevention of Dementia in Memory Clinics: Implementation and (Cost-)Effectiveness of an Integrated Lifestyle Intervention
Lifestyle Intervention in the memory clinics of General and academic Hospitals Trial (LIGHT) is a multi-center, randomized, controlled, lifestyle intervention trial among 300 older adults (≥50 years) with subjective cognitive decline (SCD) and mild cognitive impairment (MCI) at risk of dementia. Participants are randomized in a 1:1 ratio to Group A (tailored lifestyle intervention) or Group B (general health advice) for a duration of 12 months. The lifestyle intervention comprises three parts 1) Lifestyle coaching, 2) a voucher program, and 3) online self-management. Group B will receive general health advice.
Read the detailed description
Rationale: Dementia prevention through lifestyle has much potential but is not implemented in routine care. Patients referred to memory clinics, such as people with mild cognitive impairment (MCI) and subjective cognitive disorder (SCD), are at high risk for dementia and tend to have a worse health and lifestyle profile. While they might greatly benefit from lifestyle changes, there is no offer to help them make those changes.
Objective: The primary objectives are to examine both the (cost-)effectiveness of an innovative 1-year lifestyle intervention on lifestyle change measured by the validated Lifestyle for Brain Health Score (LIBRA) in older adults with SCD or MCI; and to identify possibilities, barriers, and facilitators for sustainable implementation of the lifestyle intervention.
Study design: Multicenter, randomized controlled trial comparing a lifestyle intervention with care as usual and general health advice.
Study population: 300 older adults (≥50 years) with SCD and MCI at risk of dementia.
Intervention: Participants are randomly allocated on a 1:1 ratio to participate either in Group A (tailored lifestyle intervention) or Group B (general health advice) for a duration of 12 months. The lifestyle intervention comprises three parts 1) Lifestyle coaching, 2) a voucher program, and 3) online self-management. Group B will receive general health advice.
Main study parameters/endpoints: The primary outcome will be change in participants' dementia risk profile as measured by the LIBRA score between baseline and 12 months. Secondary outcomes include cognitive functions (episodic memory, executive functions, information processing speed and attention). Other secondary outcomes include measures of body mass index (height and weight), office systolic and diastolic blood pressure, and lab measures including cholesterol levels (total, HDL, LDL, triglycerides), HbA1c levels, creatinine-based eGFR levels. Smoking, alcohol intake and current relevant medical conditions (coronary heart disease, kidney disease, type 2 diabetes, depression, hearing loss, sleep disorders) will be assessed through self-report. Additional questionnaires include health-related quality of life and capabilities, instrumental activities of daily living, health locus of control, self-efficacy, mastery, healthy diet, physical activity, cognitive stimulation, stress, and depressive symptoms, sleep quality, social support and feelings of loneliness, and lastly knowledge on dementia risk and protective factors. For cost-effectiveness, questionnaires on resource utilization, medical consumption, and productivity costs are administered. Additional measures include change in diagnosis (if applicable), demographics (age, sex, educational level, socioeconomic position (household income), paid/voluntary work hours, ethnicity, marital status, living situation), medication use, hearing loss. For process evaluation, questionnaires and interviews are administered on implementation, mechanisms of impact and contact (e.g., appointments with lifestyle coach, use of the breinzorg.nl self-management tool, use of the voucher program, experiences and usefulness, etc.).
- Being tested
- Personalized lifestyle intervention
- Keywords
- Lifestyle intervention, Risk reduction, Dementia, Memory clinic
- Medical subject headings
- Risk Reduction Behavior, Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized lifestyle interventionBehavioural
The lifestyle intervention in Group A comprises three parts (1) three individual consultations with a trained lifestyle coach, (2) a voucher program to encourage brain healthy activities, and (3) access to an online self-management tool for dementia risk reduction (www.breinzorg.nl).
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle intervention (Group A) | Experimental | Group A receives a personalized lifestyle intervention. Receives: Behavioral: Personalized lifestyle intervention |
| Regular healthcare (Group B) | No intervention | Group B receives regular health care and a folder with general information on lifestyle and dementia risk reduction. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lifestyle for BRAin Health (LIBRA) score 2
1-year change in the Lifestyle for BRAin Health (LIBRA) score 2. This is a weighted score of fifteen lifestyle-related risk factors that are proven to be associated with increased dementia risk. Higher score means a greater risk for dementia. Scored from -6.1 to 25.8 (absolute weight).
Measured: 1 year
Secondary outcomes (31)
15-Word Verbal Learning Test
Measure of immediate and delayed memory. Wordlist is presented five times in a row and asked to be recalled immediately and after 15 minutes.
Discrete number; score: 0-15 (higher score means a better outcome)
Measured: 1 year
Digit Symbol Substitution Test (DSST)
Measure of attention/processing speed, number of correctly matched symbols to digits within 90 seconds.
Discrete number; 0-90 (higher score means a better outcome).
Measured: 1 year
Wechsler Adult Intelligent Scale (WAIS) digit span
Measure of working memory. Scored as the maximum number of digits repeated correctly. Discrete number; 0-14 (higher score means a better outcome).
Measured: 1 year
Trail Making Test
Measure of attention and executive function. Task A and B. Time taken to complete the test; minimum 0, no maximum, lower score means a better outcome.
Measured: 1 year
Semantic Fluency Test
Measure of language fluency. Semantic fluency test with category animals at baseline and professions at follow-up. Word count in one minute; minimum 0, no maximum, higher score means a better outcome.
Measured: 1 year
EuroQol-5D-5L
Quality of life, score 0-100, higher scores indicate better quality of life
Measured: 1 year
ICEpop CAPability measure for Older people (ICECAP-O)
Capabilities, score 0-1, higher scores indicate greater capabilities.
Measured: 1 year
Health locus of Control Scale
3 subscales, where each subscale ranges from 6 (minimum score) to 36 (maximum score). Higher scores indicate higher health locus of control.
Measured: 1 year
General Self-Efficacy scale
Total score ranges from 10 (minimum score) to 40 (maximum score), with higher scores representing higher self-efficacy.
Measured: 1 year
Pearlin Mastery Scale
Total score ranges from 7 (minimum score) to 28 (maximum score), where higher scores indicate greater levels of mastery.
Measured: 1 year
Cholesterol
Total, HDL, LDL and triglycerides in plasma (mmol/L).
Measured: 1 year
Hemoglobin A1c
Hemoglobin A1C (HbA1c) measured in plasma (%), indicates plasma glucose as a measure for diabetes status
Measured: 1 year
Estimated glomerular filtration rate (eGFR)
Creatinine-based (as measured in plasma) estimated glomerular filtration rate (eGFR) (healthy level: higher than 60) indicating kidney function.
Measured: 1 year
Body mass Index (BMI)
As calculated from weight (kg) and height (m), weight / height ^2
Measured: 1 year
Blood pressure
Scores range from approximately (for diastolic) 60-120 and (for systolic) 100-180 mmHg, with higher measures indicating higher blood pressure.
Measured: 1 year
Medical history
History of diabetes, coronary heart disease, kidney disease, hypertension, dyslipidemia, depression, hearing loss, poor vision, sleep disorders (asked in interview)
Measured: 1 year
Amsterdam-Instrumental Activities Daily Living (ADL) Questionnaire
Total scores range approximately 20-70, higher scores indicate better ADL functioning.
Measured: 1 year
Mediterranean Diet Adherence Screener (MEDAS)
Total score ranges from 0 (minimum score) to 14 (maximum score), with higher scores indicating higher adherence to Mediterranean diet.
Measured: 1 year
Investigation into Cancer and Nutrition (EPIC) physical activity questionnaire
Physical activity, uses Cambridge Physical Activity Index to categorize into 4 levels based on occupational and leisure-time activities.
Measured: 1 year
Cognitive and Leisure Activities Scale
The score ranges from 0 (minimum score) to 45 (maximum score), with higher scores representing higher cognitive and leisure activities.
Measured: 1 year
Perceived Stress Scale
Total score, scale 0 - 40, higher scores indicate more perceived stress.
Measured: 1 year
Patient Health Questionnaire (PHQ)-9
Total score ranges from 0 (minimum score) to 27 (maximum score), with higher scores representing a worse outcome (more depressive symptoms).
Measured: 1 year
Groningen Sleep Quality Scale (GSKS)
The score ranges from 0 (minimum score) to 14 (maximum score), with higher scores representing a worse outcome (worse sleep quality)
Measured: 1 year
6-item Lubben social network Scale
The score ranges from 0 (minimum score) to 30 (maximum score), with higher scores meaning a better outcome (higher level of perceived social support)
Measured: 1 year
De Jong Gierveld 6-item Scale
The score ranges from 0 (minimum score) to 6 (maximum score), with higher scores representing a worse outcome (higher loneliness scores).
Measured: 1 year
Knowledge on dementia risk questionnaire
Measure awareness on risk and protective factors, higher score indicates better knowledge (0-25).
Measured: 1 year
Smoking
Duration (current/history) and quantity
Measured: 1 year
Alcohol intake
Measured in duration (current/history) and quantity
Measured: 1 year
Medical Consumption Questionnaire (iMCQ)
Medical consumption, selection of specific questions on care use such as GP visits and dietician. Used to calculate overall costs of medical care to define the cost-effectiveness of the intervention. Lower costs is a better score.
Measured: 1 year
Productivity Costs Questionnaire (iPCQ)
Measures productivity costs, used to calculate cost-effectiveness of the intervention. Higher productivity and lower costs is a better score.
Measured: 1 year
Adherence
Appointments missed, personal goals reached in coaching sessions (number), vouchers used (number), usage log of breinzorg.nl self-management tool (time active, modules completed). Together, they will be used in a model to calculate cost-effectiveness of the intervention based on the adherence.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start27 Jan 2025
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lifestyle InterventionStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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
- Group A receives a personalised lifestyle intervention. Group B will receive general information on lifestyle in relation to dementia risk reduction.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Amsterdam UMC, location VUmc, InHolland University of Applied Sciences
- Responsible party
- Sponsor
- Investigators
- Sebastian Köhler, Professor, Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06832761
- Sponsor's protocol ID
- NL86513.068.24
- Other IDs
- 10930012310012
- Acronym
- LIGHT
- Status last verified
- Oct 2026
- First submitted
- 23 Dec 2024
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Deckers K, Zwan MD, Soons LM, Waterink L, Beers S, van Houdt S, Stiensma B, Kwant JZ, Wimmers SCPM, Heutz RAM, Claassen JAHR, Oosterman JM, de Heus RAA, van de Rest O, Vermeiren Y, Voshaar RCO, Smidt N, Broersen LM, Sikkes SAM, Aarts E; MOCIA consortium; FINGER-NL consortium; Kohler S, van der Flier WM. A multidomain lifestyle intervention to maintain optimal cognitive functioning in Dutch older adults-study design and baseline characteristics of the FINGER-NL randomized controlled trial. Alzheimers Res Ther. 2024 Jun 13;16(1):126. doi: 10.1186/s13195-024-01495-8.
PubMed 38872204Rosenau C, Kohler S, Soons LM, Anstey KJ, Brayne C, Brodaty H, Engedal K, Farina FR, Ganguli M, Livingston G, Lyketsos CG, Mangialasche F, Middleton LE, Rikkert MGMO, Peters R, Sachdev PS, Scarmeas N, Salbaek G, van Boxtel MPJ, Deckers K. Umbrella review and Delphi study on modifiable factors for dementia risk reduction. Alzheimers Dement. 2024 Mar;20(3):2223-2239. doi: 10.1002/alz.13577. Epub 2023 Dec 30.
PubMed 38159267van Gils V, Waterink L, Wimmers SCPM, Jelsma JGM, de Vugt ME, Handels R, Sikkes SAM, van der Flier WM, Deckers K, Zwan MD, Kohler S, Janssen N. The Lifestyle Intervention in memory clinics of General and academic Hospitals Trial (LIGHT): Rationale and study design of a randomized controlled trial to reduce modifiable dementia risk. Alzheimers Res Ther. 2026 Jan 8;18(1):31. doi: 10.1186/s13195-025-01947-9.
PubMed 41508135
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Secondary Prevention of Dementia in Memory Clinics: Implementation and (Cost-)Effectiveness of an Integrated Lifestyle Intervention
- ClinicalTrials.gov ID
- NCT06832761
- Acronym / sponsor ID
- LIGHT / NL86513.068.24
- Keywords
- Lifestyle intervention, Risk reduction, Dementia, Memory clinic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Amsterdam UMC, location VUmc, InHolland University of Applied Sciences
- Study start
- 27 Jan 2025 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 18 Feb 2025 (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.
Lifestyle Intervention in the memory clinics of General and academic Hospitals Trial (LIGHT) is a multi-center, randomized, controlled, lifestyle intervention trial among 300 older adults (≥50 years) with subjective cognitive decline (SCD) and mild cognitive impairment (MCI) at risk of dementia. Participants are randomized in a 1:1 ratio to Group A (tailored lifestyle intervention) or Group B (general health advice) for a duration of 12 months. The lifestyle intervention comprises three parts 1) Lifestyle coaching, 2) a voucher program, and 3) online self-management. Group B will receive general health advice.
Detailed description
Rationale: Dementia prevention through lifestyle has much potential but is not implemented in routine care. Patients referred to memory clinics, such as people with mild cognitive impairment (MCI) and subjective cognitive disorder (SCD), are at high risk for dementia and tend to have a worse health and lifestyle profile. While they might greatly benefit from lifestyle changes, there is no offer to help them make those changes.
Objective: The primary objectives are to examine both the (cost-)effectiveness of an innovative 1-year lifestyle intervention on lifestyle change measured by the validated Lifestyle for Brain Health Score (LIBRA) in older adults with SCD or MCI; and to identify possibilities, barriers, and facilitators for sustainable implementation of the lifestyle intervention.
Study design: Multicenter, randomized controlled trial comparing a lifestyle intervention with care as usual and general health advice.
Study population: 300 older adults (≥50 years) with SCD and MCI at risk of dementia.
Intervention: Participants are randomly allocated on a 1:1 ratio to participate either in Group A (tailored lifestyle intervention) or Group B (general health advice) for a duration of 12 months. The lifestyle intervention comprises three parts 1) Lifestyle coaching, 2) a voucher program, and 3) online self-management. Group B will receive general health advice.
Main study parameters/endpoints: The primary outcome will be change in participants' dementia risk profile as measured by the LIBRA score between baseline and 12 months. Secondary outcomes include cognitive functions (episodic memory, executive functions, information processing speed and attention). Other secondary outcomes include measures of body mass index (height and weight), office systolic and diastolic blood pressure, and lab measures including cholesterol levels (total, HDL, LDL, triglycerides), HbA1c levels, creatinine-based eGFR levels. Smoking, alcohol intake and current relevant medical conditions (coronary heart disease, kidney disease, type 2 diabetes, depression, hearing loss, sleep disorders) will be assessed through self-report. Additional questionnaires include health-related quality of life and capabilities, instrumental activities of daily living, health locus of control, self-efficacy, mastery, healthy diet, physical activity, cognitive stimulation, stress, and depressive symptoms, sleep quality, social support and feelings of loneliness, and lastly knowledge on dementia risk and protective factors. For cost-effectiveness, questionnaires on resource utilization, medical consumption, and productivity costs are administered. Additional measures include change in diagnosis (if applicable), demographics (age, sex, educational level, socioeconomic position (household income), paid/voluntary work hours, ethnicity, marital status, living situation), medication use, hearing loss. For process evaluation, questionnaires and interviews are administered on implementation, mechanisms of impact and contact (e.g., appointments with lifestyle coach, use of the breinzorg.nl self-management tool, use of the voucher program, experiences and usefulness, etc.).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Group A receives a personalised lifestyle intervention. Group B will receive general information on lifestyle in relation to dementia risk reduction.
| Arm | Type | Receives |
|---|---|---|
| Lifestyle intervention (Group A) | Experimental | Behavioral: Personalized lifestyle interventionGroup A receives a personalized lifestyle intervention. |
| Regular healthcare (Group B) | No intervention | –Group B receives regular health care and a folder with general information on lifestyle and dementia risk reduction. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥50 years of age at pre-screening;
- Having a diagnosis of SCD or MCI;
- Presence of ≥ 2 modifiable risk factors for dementia.
Key exclusion criteria (4 listed)
- Having a diagnosis of dementia;
- Insufficient understanding of the Dutch language;
- Conditions affecting safe and continuous engagement in the intervention (e.g. under treatment for current malignant diseases, major psychiatric disorders (e.g. major depression, psychosis, bipolar disorder), other conditions preventing co-operation as judged by the local study nurse or consulted physician at the local study site;
- Participation in any other research intervention trial at time of pre-screening and throughout the study period.
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 |
|---|---|---|
| Personalized lifestyle interventionThe lifestyle intervention in Group A comprises three parts (1) three individual consultations with a trained lifestyle coach, (2) a voucher program to encourage brain healthy activities, and (3) access to an online self-management tool for dementia risk reduction (www.breinzorg.nl). | Behavioural | Lifestyle intervention (Group A) |
Primary outcome
Lifestyle for BRAin Health (LIBRA) score 2
Time frame: 1 year
1-year change in the Lifestyle for BRAin Health (LIBRA) score 2. This is a weighted score of fifteen lifestyle-related risk factors that are proven to be associated with increased dementia risk. Higher score means a greater risk for dementia. Scored from -6.1 to 25.8 (absolute weight).
31 secondary outcomes
15-Word Verbal Learning Test
Time frame: 1 year
Digit Symbol Substitution Test (DSST)
Time frame: 1 year
Wechsler Adult Intelligent Scale (WAIS) digit span
Time frame: 1 year
Trail Making Test
Time frame: 1 year
Semantic Fluency Test
Time frame: 1 year
EuroQol-5D-5L
Time frame: 1 year
ICEpop CAPability measure for Older people (ICECAP-O)
Time frame: 1 year
Health locus of Control Scale
Time frame: 1 year
General Self-Efficacy scale
Time frame: 1 year
Pearlin Mastery Scale
Time frame: 1 year
Cholesterol
Time frame: 1 year
Hemoglobin A1c
Time frame: 1 year
Estimated glomerular filtration rate (eGFR)
Time frame: 1 year
Body mass Index (BMI)
Time frame: 1 year
Blood pressure
Time frame: 1 year
Medical history
Time frame: 1 year
Amsterdam-Instrumental Activities Daily Living (ADL) Questionnaire
Time frame: 1 year
Mediterranean Diet Adherence Screener (MEDAS)
Time frame: 1 year
Investigation into Cancer and Nutrition (EPIC) physical activity questionnaire
Time frame: 1 year
Cognitive and Leisure Activities Scale
Time frame: 1 year
Perceived Stress Scale
Time frame: 1 year
Patient Health Questionnaire (PHQ)-9
Time frame: 1 year
Groningen Sleep Quality Scale (GSKS)
Time frame: 1 year
6-item Lubben social network Scale
Time frame: 1 year
De Jong Gierveld 6-item Scale
Time frame: 1 year
Knowledge on dementia risk questionnaire
Time frame: 1 year
Smoking
Time frame: 1 year
Alcohol intake
Time frame: 1 year
Medical Consumption Questionnaire (iMCQ)
Time frame: 1 year
Productivity Costs Questionnaire (iPCQ)
Time frame: 1 year
Adherence
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Background: PubMed 38872204Deckers K, Zwan MD, Soons LM, Waterink L, Beers S, van Houdt S, Stiensma B, Kwant JZ, Wimmers SCPM, Heutz RAM, Claassen JAHR, Oosterman JM, de Heus RAA, van de Rest O, Vermeiren Y, Voshaar RCO, Smidt N, Broersen LM, Sikkes SAM, Aarts E; MOCIA consortium; FINGER-NL consortium; Kohler S, van der Flier WM. A multidomain lifestyle intervention to maintain optimal cognitive functioning in Dutch older adults-study design and baseline characteristics of the FINGER-NL randomized controlled trial. Alzheimers Res Ther. 2024 Jun 13;16(1):126. doi: 10.1186/s13195-024-01495-8.
- Background: PubMed 38159267Rosenau C, Kohler S, Soons LM, Anstey KJ, Brayne C, Brodaty H, Engedal K, Farina FR, Ganguli M, Livingston G, Lyketsos CG, Mangialasche F, Middleton LE, Rikkert MGMO, Peters R, Sachdev PS, Scarmeas N, Salbaek G, van Boxtel MPJ, Deckers K. Umbrella review and Delphi study on modifiable factors for dementia risk reduction. Alzheimers Dement. 2024 Mar;20(3):2223-2239. doi: 10.1002/alz.13577. Epub 2023 Dec 30.
- Derived from this study: PubMed 41508135van Gils V, Waterink L, Wimmers SCPM, Jelsma JGM, de Vugt ME, Handels R, Sikkes SAM, van der Flier WM, Deckers K, Zwan MD, Kohler S, Janssen N. The Lifestyle Intervention in memory clinics of General and academic Hospitals Trial (LIGHT): Rationale and study design of a randomized controlled trial to reduce modifiable dementia risk. Alzheimers Res Ther. 2026 Jan 8;18(1):31. doi: 10.1186/s13195-025-01947-9.
- ZonMw descriptionLink provided by the sponsor.
- Alzheimer Center Limburg descriptionLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Sebastian Köhler, Professor principal investigator
Maastricht University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized lifestyle intervention in people with Lifestyle Intervention and Lifestyle Risk Reduction, run by Maastricht University Medical Center at 2 sites in Netherlands.
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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Niels Janssen, PhD (+316 14348188, n.janssen@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lifestyle for BRAin Health (LIBRA) score 2 (time frame: 1 year). 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 NCT06832761, which also lists 3 linked publications.
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 15 Oct 2026.