NCT05256199

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,210

participants targeted

Target at P75+ for not_applicable

Timeline
13mo left

Started Feb 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Feb 2022Jun 2027

First Submitted

Initial submission to the registry

January 11, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

February 24, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 25, 2022

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Expected
Last Updated

January 7, 2025

Status Verified

January 1, 2025

Enrollment Period

3.3 years

First QC Date

January 11, 2022

Last Update Submit

January 6, 2025

Conditions

Cognitive DeclineLife StyleRisk Reduction

Outcome Measures

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)).

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

Secondary Outcomes (36)

  • 15-Word Verbal Learning Test delayed recall

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

  • Digit Symbol Substitution Test 90 seconds

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

  • Wechsler Adult Intelligence Scale (WAIS) digit span backwards

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

  • Semantic fluency

    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)

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

  • +31 more secondary outcomes

Other Outcomes (2)

  • MOCA

    baseline

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

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

Study Arms (2)

high-intensity group

EXPERIMENTAL

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

Behavioral: Multidomain lifestyle intervention

low-intensity group

NO INTERVENTION

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

Interventions

Multidomain lifestyle interventionBEHAVIORAL

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.

high-intensity group

Eligibility Criteria

Age60 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Alzheimer Center Amsterdam

Amsterdam, Netherlands

Location

University Medical Center Groningen

Groningen, Netherlands

Location

Maastricht University

Maastricht, Netherlands

Location

Radboud University

Nijmegen, Netherlands

Location

Wageningen Unversity and Research

Wageningen, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 38872204DERIVED

MeSH Terms

Conditions

Cognitive DysfunctionRisk Reduction Behavior

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersBehavior

Study Officials

  • Wiesje M van der Flier, Prof

    Alzheimer Center Amsterdam

    PRINCIPAL INVESTIGATOR

  • Sebastian Köhler, Ass Prof

    Maastricht University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ass. PI

Study Record Dates

First Submitted

January 11, 2022

First Posted

February 25, 2022

Study Start

February 24, 2022

Primary Completion

June 1, 2025

Study Completion (Estimated)

June 1, 2027

Last Updated

January 7, 2025

Record last verified: 2025-01

Locations

NL(5)