NCT06832761

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
19mo left

Started Jan 2025

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
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 Progress45%
Jan 2025Dec 2027

First Submitted

Initial submission to the registry

December 23, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

January 27, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 18, 2025

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

February 18, 2025

Status Verified

February 1, 2025

Enrollment Period

2.8 years

First QC Date

December 23, 2024

Last Update Submit

February 12, 2025

Conditions

Lifestyle InterventionLifestyle Risk ReductionCognitive DeclineDementia

Keywords

Lifestyle interventionRisk reductionDementiaMemory clinic

Outcome Measures

Primary Outcomes (1)

  • 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).

    1 year

Secondary Outcomes (31)

  • 15-Word Verbal Learning Test

    1 year

  • Digit Symbol Substitution Test (DSST)

    1 year

  • Wechsler Adult Intelligent Scale (WAIS) digit span

    1 year

  • Trail Making Test

    1 year

  • Semantic Fluency Test

    1 year

  • +26 more secondary outcomes

Other Outcomes (1)

  • Biomarkers

    1 year

Study Arms (2)

Lifestyle intervention (Group A)

EXPERIMENTAL

Group A receives a personalized lifestyle intervention.

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.

Interventions

Personalized lifestyle interventionBEHAVIORAL

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).

Lifestyle intervention (Group A)

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥50 years of age at pre-screening;
  • Having a diagnosis of SCD or MCI;
  • Presence of ≥ 2 modifiable risk factors for dementia.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Alzheimer Center Amsterdam

Amsterdam, Netherlands

RECRUITING

Maastricht University

Maastricht, Netherlands

RECRUITING

Related Publications (3)

  • 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: 38872204BACKGROUND

  • Rosenau 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.

    PMID: 38159267BACKGROUND

  • van 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. doi: 10.1186/s13195-025-01947-9. Online ahead of print.

    PMID: 41508135DERIVED

Related Links

MeSH Terms

Conditions

Risk Reduction BehaviorCognitive DysfunctionDementia

Condition Hierarchy (Ancestors)

BehaviorCognition DisordersNeurocognitive DisordersMental DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Sebastian Köhler, Professor

    Maastricht University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Niels Janssen, PhD

CONTACT

+316 14348188n.janssen@maastrichtuniversity.nl

Veerle van Gils, PhD

CONTACT

+316 14348188v.vangils@maastrichtuniversity.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Group A receives a personalised lifestyle intervention. Group B will receive general information on lifestyle in relation to dementia risk reduction.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2024

First Posted

February 18, 2025

Study Start

January 27, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

February 18, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

NL(2)