Lifestyle intervention for older adults at risk of dementia
Secondary Prevention of Dementia in Memory Clinics: Implementation and (Cost-)Effectiveness of an Integrated Lifestyle Intervention
This study is testing a personalized lifestyle program to see if it can help older adults at risk of dementia improve their brain health over a year.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Maastricht University Medical Center Academic / other |
| Locations | 2 sites (Amsterdam and 1 other locations) |
| Trial ID | NCT06832761 on ClinicalTrials.gov |
What this trial studies
This trial evaluates a tailored lifestyle intervention aimed at reducing dementia risk among older adults with subjective cognitive decline (SCD) and mild cognitive impairment (MCI). It involves a randomized controlled design with 300 participants, who are assigned to either a personalized lifestyle intervention group or a general health advice group for 12 months. The intervention includes lifestyle coaching, a voucher program, and online self-management tools. The study aims to assess the effectiveness of the intervention in improving participants' dementia risk profiles and to explore the feasibility of implementing such interventions in routine care.
Who should consider this trial
Good fit: Ideal candidates are older adults aged 50 and above with subjective cognitive decline or mild cognitive impairment and at least two modifiable risk factors for dementia.
Not a fit: Patients with a diagnosis of dementia or those unable to engage safely in the intervention due to other health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the risk of dementia in older adults through lifestyle modifications.
How similar studies have performed: Previous studies have shown promise in lifestyle interventions for dementia risk reduction, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ≥50 years of age at pre-screening; * Having a diagnosis of SCD or MCI; * Presence of ≥ 2 modifiable risk factors for dementia. Exclusion Criteria: * 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.
Where this trial is running
Amsterdam and 1 other locations
- Alzheimer Center Amsterdam — Amsterdam, Netherlands (Recruiting)
- Maastricht University — Maastricht, Netherlands (Recruiting)
Study contacts
- Principal investigator: Sebastian Köhler, Professor — Maastricht University
- Study coordinator: Niels Janssen, PhD
- Email: n.janssen@maastrichtuniversity.nl
- Phone: +316 14348188
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.