Lifestyle Intervention in the Memory Clinics of General and Academic Hospitals Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorMaastricht University Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥50 years of age at pre-screening;
Having a diagnosis of SCD or MCI;
Presence of ≥ 2 modifiable risk factors for dementia.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Personalized lifestyle intervention
BehavioralThe 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).
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Lifestyle intervention (Group A)Experimental treatment 1 intervention
Group B: Regular healthcare (Group B)No intervention 0 interventions
Trial outcomes
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).
Time frame
1 yearSecondary outcomes
1
15-Word Verbal Learning Test
Measure of immediate and delayed memory. Wordlist is presented five times in a row and asked to be recalled immediately and after 15 minutes. Discrete number; score: 0-15 (higher score means a better outcome)
Time frame
1 year2
Digit Symbol Substitution Test (DSST)
Measure of attention/processing speed, number of correctly matched symbols to digits within 90 seconds. Discrete number; 0-90 (higher score means a better outcome).
Time frame
1 year3
Wechsler Adult Intelligent Scale (WAIS) digit span
Measure of working memory. Scored as the maximum number of digits repeated correctly. Discrete number; 0-14 (higher score means a better outcome).
Time frame
1 year4
Trail Making Test
Measure of attention and executive function. Task A and B. Time taken to complete the test; minimum 0, no maximum, lower score means a better outcome.
Time frame
1 yearOther outcomes
1
Biomarkers
Plasma samples will be stored to later assess biomarkers. For example amyloid, p-tau, NFL, GFAP, BDNF.
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Maastricht University Medical Center
Lead sponsor
Amsterdam UMC, location VUmc
Collaborator
InHolland University of Applied Sciences
Collaborator
Source ClinicalTrials.gov