Actively Recruiting

Phase Not Applicable
Age: 50Years +
All Genders
ID06832761

Secondary Prevention of Dementia in Memory Clinics: Implementation and (Cost-)Effectiveness of an Integrated Lifestyle Intervention

Led by Maastricht University Medical Center · Updated on 2025-02-18

300

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

Sponsors

M

Maastricht University Medical Center

Lead Sponsor

A

Amsterdam UMC, location VUmc

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying older adults aged 50 years and above who have subjective cognitive decline (SCD) or mild cognitive impairment (MCI) and are at risk for dementia. This multi-center randomized controlled trial called LIGHT aims to evaluate the impact and cost-effectiveness of a one-year lifestyle intervention on lifestyle changes and dementia risk reduction compared with general health advice. The study focuses on improving factors related to brain health and identifying how to best implement sustainable lifestyle changes in memory clinic patients. Participants are randomly assigned to one of two groups for 12 months. Group A receives a personalized lifestyle intervention that includes three individual coaching sessions with a trained lifestyle coach, a voucher program to promote brain-healthy activities, and access to an online self-management tool for dementia risk reduction. Group B receives general health advice and regular healthcare, including an informational folder about lifestyle and dementia risk reduction. Throughout the study, participants undergo various assessments including cognitive tests, measurements of body mass index, blood pressure, cholesterol, and blood sugar levels. Questionnaires cover lifestyle habits, health status, quality of life, physical activity, stress, sleep quality, social support, and knowledge of dementia risk factors. Researchers also collect data on healthcare use and costs. The primary outcome is the change in dementia risk profile measured by the Lifestyle for Brain Health (LIBRA) score after one year. Additional evaluations include interviews and questionnaires about the intervention's implementation and participant experiences.

CONDITIONS

Brief Title

Lifestyle Intervention in the Memory Clinics of General and Academic Hospitals Trial

Who Can Participate

Age: 50Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 50 years of age or older at pre-screening
  • Diagnosed with subjective cognitive decline (SCD) or mild cognitive impairment (MCI)
  • Presence of two or more modifiable risk factors for dementia
Not Eligible

You will not qualify if you...

  • Diagnosis of dementia
  • Insufficient understanding of the Dutch language
  • Conditions preventing safe and continuous participation, such as current malignant diseases under treatment or major psychiatric disorders (e.g., major depression, psychosis, bipolar disorder)
  • Participation in any other research intervention trial at pre-screening or during the study period

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 12 months

Participants receive either a personalized lifestyle intervention including coaching, a voucher program, and online self-management tools, or general health advice over the course of one year.

Multiple visits during the 12 months for coaching and assessments

Follow-up

Duration - Assessments throughout and at the end of the 12-month period

Participants complete assessments on lifestyle, cognitive function, physical health, and quality of life to evaluate the effectiveness of the intervention.

Visits coincide with treatment period assessments

Trial Site Locations

Total: 2 locations

1

Alzheimer Center Amsterdam

Amsterdam, Netherlands

Actively Recruiting

2

Maastricht University

Maastricht, Netherlands

Actively Recruiting

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Research Team

N

Niels Janssen, PhD

V

Veerle van Gils, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

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.

Kay Deckers, Marissa D Zwan, Lion M Soons...

https://pubmed.ncbi.nlm.nih.gov/38872204

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.

V van Gils, L Waterink, S C P M Wimmers...

https://pubmed.ncbi.nlm.nih.gov/41508135