Dutch Multidomain Lifestyle Intervention in Older Adults at Risk of Cognitive Decline (FINGER-NL)

May 29, 2026 updated by: Marissa Zwan, Alzheimercentrum Amsterdam
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1210

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Marissa D. Zwan

Study Locations

  • Netherlands
      • Amsterdam, Netherlands, 1671 EA
        • Alzheimer Center Amsterdam
      • Groningen, Netherlands
        • University Medical Center Groningen
      • Maastricht, Netherlands
        • Maastricht University
      • Nijmegen, Netherlands
        • Radboud University
      • Wageningen, Netherlands
        • Wageningen Unversity and Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 60-79 years of age at pre-screening;
  • Adequate fluency in Dutch to understand the informed consent 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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: high-intensity group
The high intensity group receives a personalized, supervised intervention consisting of group meetings and individual sessions.
Behavioral: Multidomain 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.
No Intervention: low-intensity group
The low-intensity arm receives online access to general lifestyle-related health information.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
2-year change from baseline in global cognitive composite score
Time Frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
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)).
2 years (measured at baseline, follow-up 1 and follow-up 2)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
15-Word Verbal Learning Test delayed recall
Time Frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
discrete number; score: 0-15 (higher score means a better outcome)
2 years (measured at baseline, follow-up 1 and follow-up 2)
Digit Symbol Substitution Test 90 seconds
Time Frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
discrete number; 0-90 (higher score means a better outcome)
2 years (measured at baseline, follow-up 1 and follow-up 2)
Wechsler Adult Intelligence Scale (WAIS) digit span backwards
Time Frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
discrete number; 0-14 (higher score means a better outcome)
2 years (measured at baseline, follow-up 1 and follow-up 2)
Semantic fluency
Time Frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
word count in one minute; minimum 0, no maximum, higher score means a better outcome.
2 years (measured at baseline, follow-up 1 and follow-up 2)
Instrumental activities of daily living using the Amsterdam Instrumental Activity of Daily Living Questionnaire (A-IADL-Q)
Time Frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Total scores range approximately 20-70, higher scores indicate better IADL functioning
2 years (measured at baseline, follow-up 1 and follow-up 2)
5 level EuroQol-5D (EQ-5D-5L)
Time Frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Quality of life, score 0-100, higher scores indicate better quality of life
2 years (measured at baseline, follow-up 1 and follow-up 2)
LIfestyle for BRAin health (LIBRA)
Time Frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
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)
2 years (measured at baseline, follow-up 1 and follow-up 2)
grip strength test
Time Frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Scores between 0 to 90 kg can be measured on the Jamar Hand dynamometer, with higher scores indicating better grip strength
2 years (measured at baseline, follow-up 1 and follow-up 2)
SQUASH questionnaire
Time Frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
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).
2 years (measured at baseline, follow-up 1 and follow-up 2)
LASA Sedentary Behavior Questionnaire
Time Frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Average hours and minutes of sedentary behavior a day, range from 0 to 24 hours. Higher scores (more hours) means a more sedentary behavior.
2 years (measured at baseline, follow-up 1 and follow-up 2)
Pittsburgh Fatigability Scale
Time Frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Total physical and mental fatigability scores range from 0-50, with higher scores indicating higher fatigability.
2 years (measured at baseline, follow-up 1 and follow-up 2)
SARC-F Sarcopenia Questionnaire
Time Frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
sarcopenia, scores range from 0 to 10 (i.e. 0-2 points for each component; 0 = best to 10 = worst).
2 years (measured at baseline, follow-up 1 and follow-up 2)
Five Facet Mindfulness Questionnaire - Short Form (FFMQ-SF)
Time Frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Total scale ranges from 24 - 120, higher scores indicate more mindfulness
2 years (measured at baseline, follow-up 1 and follow-up 2)
Perceived Stress Scale
Time Frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Total score, scale 0 - 40, higher scores indicate more perceived stress
2 years (measured at baseline, follow-up 1 and follow-up 2)
MetaMemory in Adulthood (MIA)
Time Frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
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.
2 years (measured at baseline, follow-up 1 and follow-up 2)
Blood pressure
Time Frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
scores range from approximately (for diastolic) 60-120 and (for systolic) 100-180 mmHg, with higher scores indicating higher blood pressure.
2 years (measured at baseline, follow-up 1 and follow-up 2)
Cholesterol
Time Frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
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)
2 years (measured at baseline, follow-up 1 and follow-up 2)
Blood glucose
Time Frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
HbA1C, scores range from approximately 30-100 mmol/mol, with higher scores indicate higher blood glucose levels.
2 years (measured at baseline, follow-up 1 and follow-up 2)
Waist circumference
Time Frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
measured in cm
2 years (measured at baseline, follow-up 1 and follow-up 2)
Hip circumference
Time Frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
measured in cm
2 years (measured at baseline, follow-up 1 and follow-up 2)
Height
Time Frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
measured in cm
2 years (measured at baseline, follow-up 1 and follow-up 2)
Weight
Time Frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
measured in kg
2 years (measured at baseline, follow-up 1 and follow-up 2)
Hill-Bone Medication Adherence Scale
Time Frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
scores range from 9-26, with lower scores indicating better medication adherence
2 years (measured at baseline, follow-up 1 and follow-up 2)
MIND-adjusted Eetscore-FFQ
Time Frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
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.
2 years (measured at baseline, follow-up 1 and follow-up 2)
Nutritional intake
Time Frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Change in nutritional intake measured by an online 3-day food diary (assessed by Traqq application), qualitative assessment
2 years (measured at baseline, follow-up 1 and follow-up 2)
Pittsburg Sleep Quality Index
Time Frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality
2 years (measured at baseline, follow-up 1 and follow-up 2)
Insomnia severity index
Time Frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
The score ranges from 0 (minimum score) to 28 (maximum score), with lower scores indicating a better outcome
2 years (measured at baseline, follow-up 1 and follow-up 2)
Lubben Social Network Scale
Time Frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
The score ranges from 0 (minimum score) to 30 (maximum score), with higher scores meaning a better outcome (higher level of perceived social support)
2 years (measured at baseline, follow-up 1 and follow-up 2)
De Jong Gierveldt Loneliness Scale
Time Frame: 2 years (measured at baseline and follow-up 2)
The score ranges from 0 (minimum score) to 6 (maximum score), with higher scores representing a worse outcome (higher loneliness scores)
2 years (measured at baseline and follow-up 2)
Aβ42/40 ratio
Time Frame: 2 years (measured at baseline and follow-up 2)
amyloid-β (1-42)/(1-40) (pg/mL)
2 years (measured at baseline and follow-up 2)
p-tau
Time Frame: 2 years (measured at baseline and follow-up 2)
phosphorylated tau (pg/mL)
2 years (measured at baseline and follow-up 2)
NfL
Time Frame: 2 years (measured at baseline and follow-up 2)
neurofilament light chain (pg/mL)
2 years (measured at baseline and follow-up 2)
GFAP
Time Frame: 2 years (measured at baseline and follow-up 2)
glial fibrillary acidic protein (pg/mL)
2 years (measured at baseline and follow-up 2)
BDNF
Time Frame: 2 years (measured at baseline and follow-up 2)
brain-derived neurotrophic factor (pg/mL)
2 years (measured at baseline and follow-up 2)
Actigraph (Groningen site only)
Time Frame: 2 year (measured for 1 week at baseline, follow-up 1 and follow-up 2)
physical activity, sedentary behavior and sleep-wake activity
2 year (measured for 1 week at baseline, follow-up 1 and follow-up 2)
Physical Activity Record questionnaire (Groningen site only)
Time Frame: 2 year (measured for 1 week at baseline, follow-up 1 and follow-up 2)
physical activity, sedentary behavior and sleep-wake activity
2 year (measured for 1 week at baseline, follow-up 1 and follow-up 2)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
MOCA
Time Frame: baseline
Montreal Cognitive Assessment, minimum score 0, maximum score 30, with higher scores indicating better cognitive performance
baseline
Motivation to Change Lifestyle and Health Behavior for Dementia Risk Reduction scale
Time Frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
scores range from 27-135, with higher scores indicating greater motivation to change
2 years (measured at baseline, follow-up 1 and follow-up 2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alzheimercentrum Amsterdam

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Radboud University Medical Center
University Medical Center Groningen
Maastricht University
Wageningen University and Research
Danone Nutricia Research

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marissa D. Zwan, Dr., Alzheimer Center Amsterdam
  • Principal Investigator: Sebastian Köhler, Prof., Maastricht University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 24, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 11, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 25, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021.0220
  • NL77242.029.21 (Other Identifier: Centrale Commissie Mensgebonden Onderzoek (CCMO))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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