ClinicalTrials.gg
Active, not recruitingNCT05256199FINGER-NLUpdated Jun 2, 2026

Dutch Multidomain Lifestyle Intervention in Older Adults at Risk of Cognitive Decline

An interventional study of Multidomain lifestyle intervention in Cognitive Decline, Life Style and Risk Reduction, sponsored by Alzheimercentrum Amsterdam. Active, not recruiting at 5 sites in Netherlands. Open to participants aged 60 Years to 79 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-02.

Sponsored by Alzheimercentrum Amsterdam · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
1,210
Allocation
Randomized
Ages
60 Years to 79 Years
Sex
All
01

Study summary

FINGER-NL is a multi-center, randomized, controlled, multidomain lifestyle intervention trial among 1,206 older adults at risk for cognitive decline with a duration of 24 months. Participants are randomized in a 1:1 ratio to a personalized multi-domain lifestyle intervention (high-intensity intervention group) versus online access to general lifestyle-related health information (low-intensity intervention group). After the intervention period, participants are invited for a 24 month extension of follow-up.

02

Conditions studied

  • Cognitive Decline
  • Life Style
  • Risk Reduction
03

In context

Cognitive Dysfunction

3,872 studies on the registry are indexed under Cognitive Dysfunction; 1,119 are open to participants now.

This study's enrollment of 1,210 is above the median of 64 across 2,794 interventional studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Lead sponsor

Alzheimercentrum Amsterdam is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 60-79 years of age at pre-screening;
  • Adequate fluency in Dutch to understand the and complete questionnaires;
  • Providing informed consent to all study procedures;
  • Internet access at home;
  • Presence of ≥3 self-reported risk factors for cognitive decline (must contain at least 2 modifiable risk factors and 1 non-modifiable riskfactor).

Exclusion criteria

Exclusion Criteria:

  • Diagnosis of dementia or mild cognitive impairment at baseline (self-reported);
  • Significant cognitive impairment assessed using the Modified Telephone Interview for Cognitive Status battery (TICSm score\<23);
  • 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), neurological disorders (e.g. Parkinson's disease, multiple sclerosis), symptomatic cardiovascular disease (e.g. stroke, angina pectoris, heart failure, myocardial infarction), re-vascularization within three months, severe loss of vision, hearing or communicative ability, severe mobility impairment, other conditions preventing co-operation) as judged by the local study nurse or consulted physician at the local study site;
  • Coincident participation in any other intervention trial at time of pre-screening.
  • Coincident participation of spouse in FINGER-NL trial.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
1,210 participants (actual)

Study arms

  • Experimental
    high-intensity group

    The high intensity group receives a personalized, supervised intervention consisting of group meetings and individual sessions.

    Behavioral: Multidomain lifestyle intervention

  • No intervention
    low-intensity group

    The low-intensity arm receives online access to general lifestyle-related health information.

Interventions

  • BehavioralMultidomain lifestyle intervention

    A multidomain lifestyle intervention, including (1) physical activity, (2) cognitive training, (3) cardiovascular risk factor management (Cardiovascular), (4) dietary counselling, (5) Souvenaid, (6) sleep counselling, (7) stress management, and (8) social activities.

06

What researchers measure

Primary outcomes

  1. 2-year change from baseline in global cognitive composite score

    Global cognitive composite score derived from subtest scores from the Neuropsychological Test Battery (NTB) that includes 15-Word Verbal Learning Test delayed recall (discrete number; 0-15 (higher score means a better outcome)), Digit Symbol Substitution Test 90 seconds (discrete number; 0-90 (higher score means a better outcome)), WAIS digit span backwards (discrete number; 0-14 (higher score means a better outcome)), and semantic fluency (discrete number; 0-no maximum, higher score means a better outcome)).

    Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)

Secondary outcomes

  1. 15-Word Verbal Learning Test delayed recall

    discrete number; score: 0-15 (higher score means a better outcome)

    Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)

  2. Digit Symbol Substitution Test 90 seconds

    discrete number; 0-90 (higher score means a better outcome)

    Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)

  3. Wechsler Adult Intelligence Scale (WAIS) digit span backwards

    discrete number; 0-14 (higher score means a better outcome)

    Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)

  4. Semantic fluency

    word count in one minute; minimum 0, no maximum, higher score means a better outcome.

    Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)

  5. Instrumental activities of daily living using the Amsterdam Instrumental Activity of Daily Living Questionnaire (A-IADL-Q)

    Total scores range approximately 20-70, higher scores indicate better IADL functioning

    Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)

  6. 5 level EuroQol-5D (EQ-5D-5L)

    Quality of life, score 0-100, higher scores indicate better quality of life

    Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)

  7. LIfestyle for BRAin health (LIBRA)

    Modifiable dementia risk using lifestyle for brain health; The score ranges from -5.9 (minimum score) to +12.7 (maximum score), with higher scores meaning a worse outcome (higher dementia risk)

    Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)

  8. grip strength test

    Scores between 0 to 90 kg can be measured on the Jamar Hand dynamometer, with higher scores indicating better grip strength

    Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)

  9. SQUASH questionnaire

    METs derived from the Ainsworth's compendium of physical activity will be used to classify physical activity intensity (\<1.5METs- sedentary, 1.6-2.9 METs- light, 3.0-5.9METs- moderate, \>6.0- vigorous physical activity).

    Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)

  10. LASA Sedentary Behavior Questionnaire

    Average hours and minutes of sedentary behavior a day, range from 0 to 24 hours. Higher scores (more hours) means a more sedentary behavior.

    Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)

  11. Pittsburgh Fatigability Scale

    Total physical and mental fatigability scores range from 0-50, with higher scores indicating higher fatigability.

    Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)

  12. SARC-F Sarcopenia Questionnaire

    sarcopenia, scores range from 0 to 10 (i.e. 0-2 points for each component; 0 = best to 10 = worst).

    Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)

  13. Five Facet Mindfulness Questionnaire - Short Form (FFMQ-SF)

    Total scale ranges from 24 - 120, higher scores indicate more mindfulness

    Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)

  14. Perceived Stress Scale

    Total score, scale 0 - 40, higher scores indicate more perceived stress

    Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)

  15. MetaMemory in Adulthood (MIA)

    Sum of Part 1 + Part 2A and B. Part 1: Strategy (scores 10 - 50, higher scores indicate more use of strategies), Part 2A: Subjective memory functioning, scores ranges from 23 - 115, with higher scores indicate better memory self-efficacy and 2B: Locus, scores ranges from 7 - 35, higher scores indicate better perceived personal control over remembering abilities.

    Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)

  16. Blood pressure

    scores range from approximately (for diastolic) 60-120 and (for systolic) 100-180 mmHg, with higher scores indicating higher blood pressure.

    Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)

  17. Cholesterol

    total (healthy level: 125 to 200mg/dL), HDL (healthy level = 40mg/dL or higher), LDL (healthy level = Less than 100mg/dL) + triglycerides (healthy level = less than 150-199 mg/dL)

    Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)

  18. Blood glucose

    HbA1C, scores range from approximately 30-100 mmol/mol, with higher scores indicate higher blood glucose levels.

    Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)

  19. Waist circumference

    measured in cm

    Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)

  20. Hip circumference

    measured in cm

    Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)

  21. Height

    measured in cm

    Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)

  22. Weight

    measured in kg

    Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)

  23. Hill-Bone Medication Adherence Scale

    scores range from 9-26, with lower scores indicating better medication adherence

    Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)

  24. MIND-adjusted Eetscore-FFQ

    Dutch Healthy Diet Index 2015 score (range 0-160 points, higher scores mean better outcome) and MIND score (range 0-15 points, higher scores mean better outcome), assessed by a short Food Frequency Questionnaire.

    Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)

  25. Nutritional intake

    Change in nutritional intake measured by an online 3-day food diary (assessed by Traqq application), qualitative assessment

    Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)

  26. Pittsburg Sleep Quality Index

    Total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality

    Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)

  27. Insomnia severity index

    The score ranges from 0 (minimum score) to 28 (maximum score), with lower scores indicating a better outcome

    Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)

  28. 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)

    Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)

  29. De Jong Gierveldt Loneliness Scale

    The score ranges from 0 (minimum score) to 6 (maximum score), with higher scores representing a worse outcome (higher loneliness scores)

    Time frame: 2 years (measured at baseline and follow-up 2)

  30. Aβ42/40 ratio

    amyloid-β (1-42)/(1-40) (pg/mL)

    Time frame: 2 years (measured at baseline and follow-up 2)

  31. p-tau

    phosphorylated tau (pg/mL)

    Time frame: 2 years (measured at baseline and follow-up 2)

  32. NfL

    neurofilament light chain (pg/mL)

    Time frame: 2 years (measured at baseline and follow-up 2)

  33. GFAP

    glial fibrillary acidic protein (pg/mL)

    Time frame: 2 years (measured at baseline and follow-up 2)

  34. BDNF

    brain-derived neurotrophic factor (pg/mL)

    Time frame: 2 years (measured at baseline and follow-up 2)

  35. Actigraph (Groningen site only)

    physical activity, sedentary behavior and sleep-wake activity

    Time frame: 2 year (measured for 1 week at baseline, follow-up 1 and follow-up 2)

  36. Physical Activity Record questionnaire (Groningen site only)

    physical activity, sedentary behavior and sleep-wake activity

    Time frame: 2 year (measured for 1 week at baseline, follow-up 1 and follow-up 2)

Other outcomes

  1. MOCA

    Montreal Cognitive Assessment, minimum score 0, maximum score 30, with higher scores indicating better cognitive performance

    Time frame: baseline

  2. Motivation to Change Lifestyle and Health Behavior for Dementia Risk Reduction scale

    scores range from 27-135, with higher scores indicating greater motivation to change

    Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)

07

Study locations

5 sites
08

References and documents

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 38872204 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05256199
Lead sponsor
Alzheimercentrum Amsterdam
Collaborators
Maastricht University, Radboud University Medical Center, Wageningen University and Research, University Medical Center Groningen, Danone Nutricia Research
Responsible party
Marissa Zwan (PI, Amsterdam UMC, location VUmc) — Principal investigator
First posted
Feb 25, 2022
Start date
Feb 24, 2022
Primary completion
Jul 30, 2025
Completion
Aug 1, 2027 (estimated)
Last update
Jun 2, 2026

Study contacts

Marissa D. Zwan, Dr.
principal investigator · Alzheimer Center Amsterdam
Sebastian Köhler, Prof.
principal investigator · Maastricht University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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