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ID
Source
Brief title
Health condition
Cognitively normal adults with risk factors for cognitive decline
Sponsors and support
Intervention
Outcome measures
Primary outcome
2-year change from baseline in global cognitive composite score derived from subtest scores from the Neuropsychological Test Battery (NTB) that includes 15-Word Verbal Learning Test delayed recall, DDST 90 seconds, WAIS digit span backwards, and animal fluency.
Secondary outcome
2-year change from baseline in:
a) individual cognitive test performances, representing memory, processing speed and attention and executive functioning;
b) Instrumental activities of daily living;
c) Quality of life;
d) Modifiable dementia risk;
e) Intervention specific outcomes
f) Blood-based biomarkers for Alzheimer’s disease (Aβ42/40, p-tau), axonal damage (NfL), astrocytes activity/injury or stress (GFAP) and brain plasticity (BDNF).
Background summary
Findings from previous observational studies have linked several vascular and lifestyle-related risk factors with increased risk of late-lifecognitive impairment. Up till 40% of dementia cases worldwide is estimated to be attributable to twelve modifiable factors (including e.g.midlife hypertension, midlife obesity, physical inactivity, and low social contact), providing prevention opportunities (1, 2). Randomisedcontrolled trials are needed to confirm whether intervention strategies targeting modifiable risk factors indeed help to maintain cognitivefunctioning (3, 4). Intervention studies targeting lifestyle factors to prevent cognitive decline and dementia have yielded mainly negativeresults, although some positive effects on cognition have been reported for dietary intervention, physical activity and cognitive training(5-12).
Successful prevention of cardiovascular disease and type 2 diabetes have emphasized the importance of a multidomain lifestyleapproach, as different aspects of lifestyle and vascular risk are thought to exert their influence in synergy (13, 14). FINGER was the firstintervention study to evaluate a multi-modal lifestyle intervention to prevent cognitive decline (15). FINGER simultaneously targeted fourlifestyle domains (physical activity, cognitive training, dietary counselling and cardiovascular risk management) and showed a positiveeffect on the cognitive composite primary outcome measure (NTB), particularly on executive functioning and processing speed. Othermulti-domain intervention studies showed a beneficial effect on cognition in specific subgroups that were at highest risk (16, 17),illustrating that for lifestyle interventions to be successful, participants should be selected for ‘prevention potential’ – i.e. there should beroom for improvement in modifiable risk factors.
Inspired by the positive results in FINGER, World-Wide FINGERS (WW-FINGERS, wwfingers.com) is a global effort to replicate theoriginal findings around the globe, while simultaneously optimizing the intervention under local circumstances. Additional lifestyledomains which may benefit cognition are sleep, mindfulness and social activities. Sleep problems increase with ageing and may beassociated with cognitive decline in older people (18). Internet-delivered cognitive behavioral strategies are promising to improve sleepefficiency and decrease insomnia (19). Second, cultivation of mindfulness has been shown to be beneficial in stress management,coping with daily events, and promotes mental resilience. Recent studies have shown that long-term mindfulness meditation practicecan help maintain brain health, by beneficially influencing inflammatory processes or vascular damage (20-23). Last, social participation can help maintain cognitive health as a result of cognitive stimulation, stress buffering or enhancement of healthy behavior (24). In thecontext of a lifestyle intervention, the latter is of particular interest, since participants can help each other adhere to the lifestyle changes.
In addition, recent developments have shown promise of medical food, specifically designed to promote synapse growth and preventcognitive decline (25, 26). Souvenaid is a medical food which has been shown to prevent cognitive decline in mild cognitive impairment(27, 28). It is conceivable that daily consumption of Souvenaid could help maintain cognitive function in elderly at risk of cognitivedecline as well.
The COVID19 pandemic has boosted the application of online delivery of interventions. Online applications have great potential forpromoting interaction with and between participants. A former review has shown that web-based lifestyle programs can positivelyinfluence brain health outcomes and have the potential to help maintain brain health (29). Particularly in the Netherlands, where internetaccess is remarkably high, also among elderly (30). Taking the original FINGER study as a starting point, and embedded in the WW-Finger network, FINGER-NL is designed as a multidomain lifestyle intervention targeting eight lifestyle aspects to improve cognitivefunctioning, with a hybrid approach including both online and on site intervention sessions.
Study objective
The primary objective is to investigate the effectiveness of a personalized 2-year multidomain lifestyle intervention on cognitive performance in older adults at risk of cognitive decline.
Study design
Outcome:
Both groups visit the study site 3 times (at baseline, follow-up 1 (12 months) and
follow-up 2 (24 months)) for outcome assessments including neuropsychological testing, clinical measures, blood sampling and questionnaires (duration ~3 hours).
Intervention:
The high-intensity intervention takes on average 3 hours per week for 24 months. The high-intensity group is supervised by an educated lifestyle coach to oversee and if necessary mitigate putative risks associated with the intervention. The low-intensity group gets online access to general lifestyle-related health information which takes on average ~30 minutes per month for 24 months.
Intervention
Participants are randomized in a 1:1 ratio to participate in either the high-intensity group or the low-intensity group for a duration of 24 months. The high-intensity multidomain lifestyle intervention comprises 8 domains, namely (1) physical activity, (2) cognitive training, (3) cardiovascular risk factor management, (4) dietary counselling, (5) Souvenaid, (6) sleep counselling, (7) stress management, and (8) social activities. The high-intensity group receives a personalized, supervised intervention consisting of group meetings and individual sessions (hybrid; both online and at study site). The low-intensity intervention group gets online access to general lifestyle-related health information covering all domains except Souvenaid.
Inclusion criteria
1. 60-79 years of age at pre-screening;
2. Adequate fluency in Dutch to understand the informed consent and complete questionnaires;
3. Providing informed consent to all study procedures;
4. Internet access at home;
5. Presence of ≥3 self-reported risk factors for cognitive decline (must contain at least 2 modifiable risk factors and 1 non-modifiable riskfactor):
Exclusion criteria
1. Diagnosis of dementia or mild cognitive impairment at baseline (self-reported);
2. Significant cognitive impairment assessed using the Modified Telephone Interview for Cognitive Status battery (TICSm score<23);
3. Conditions affecting safe and continuous engagement in the intervention
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL9634 |
| Other | METc VUmc : METc 2021.0220 |