Dutch Multidomain Lifestyle Intervention in Older Adults at Risk of Cognitive Decline

Alzheimercentrum Amsterdam5 sites in 1 country1,210 target enrollmentFebruary 24, 2022

ConditionsCognitive Decline Life Style Risk Reduction

Overview

Phase: N/A
Intervention: Not specified
Conditions: Cognitive Decline
Sponsor: Alzheimercentrum Amsterdam
Enrollment: 1210
Locations: 5
Primary Endpoint: 2-year change from baseline in global cognitive composite score
Status: Active, Not Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

FINGER-NL is a multi-center, randomized, controlled, multidomain lifestyle intervention trial among 1,206 older adults at risk for cognitive decline with a duration of 24 months. Participants are randomized in a 1:1 ratio to a personalized multi-domain lifestyle intervention (high-intensity intervention group) versus online access to general lifestyle-related health information (low-intensity intervention group). After the intervention period, participants are invited for a 24 month extension of follow-up.

Registry

clinicaltrials.gov

Start Date

February 24, 2022

End Date

June 1, 2027

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Alzheimercentrum Amsterdam

Responsible Party

Principal Investigator

Marissa Zwan

ass. PI

Amsterdam UMC, location VUmc

Eligibility Criteria

Inclusion Criteria

•60-79 years of age at pre-screening;
•Adequate fluency in Dutch to understand the informed consent and complete questionnaires;
•Providing informed consent to all study procedures;
•Internet access at home;
•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

•Diagnosis of dementia or mild cognitive impairment at baseline (self-reported);
•Significant cognitive impairment assessed using the Modified Telephone Interview for Cognitive Status battery (TICSm score\<23);
•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), neurological disorders (e.g. Parkinson's disease, multiple sclerosis), symptomatic cardiovascular disease (e.g. stroke, angina pectoris, heart failure, myocardial infarction), re-vascularization within three months, severe loss of vision, hearing or communicative ability, severe mobility impairment, other conditions preventing co-operation) as judged by the local study nurse or consulted physician at the local study site;
•Coincident participation in any other intervention trial at time of pre-screening.
•Coincident participation of spouse in FINGER-NL trial.

Outcomes

Primary Outcomes

2-year change from baseline in global cognitive composite score

Time Frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)

Global cognitive composite score derived from subtest scores from the Neuropsychological Test Battery (NTB) that includes 15-Word Verbal Learning Test delayed recall (discrete number; 0-15 (higher score means a better outcome)), Digit Symbol Substitution Test 90 seconds (discrete number; 0-90 (higher score means a better outcome)), WAIS digit span backwards (discrete number; 0-14 (higher score means a better outcome)), and semantic fluency (discrete number; 0-no maximum, higher score means a better outcome)).

Secondary Outcomes

15-Word Verbal Learning Test delayed recall(2 years (measured at baseline, follow-up 1 and follow-up 2))
LASA Sedentary Behavior Questionnaire(2 years (measured at baseline, follow-up 1 and follow-up 2))
Wechsler Adult Intelligence Scale (WAIS) digit span backwards(2 years (measured at baseline, follow-up 1 and follow-up 2))
Semantic fluency(2 years (measured at baseline, follow-up 1 and follow-up 2))
Aβ42/40 ratio(2 years (measured at baseline and follow-up 2))
Digit Symbol Substitution Test 90 seconds(2 years (measured at baseline, follow-up 1 and follow-up 2))
Instrumental activities of daily living using the Amsterdam Instrumental Activity of Daily Living Questionnaire (A-IADL-Q)(2 years (measured at baseline, follow-up 1 and follow-up 2))
5 level EuroQol-5D (EQ-5D-5L)(2 years (measured at baseline, follow-up 1 and follow-up 2))
LIfestyle for BRAin health (LIBRA)(2 years (measured at baseline, follow-up 1 and follow-up 2))
grip strength test(2 years (measured at baseline, follow-up 1 and follow-up 2))
Five Facet Mindfulness Questionnaire - Short Form (FFMQ-SF)(2 years (measured at baseline, follow-up 1 and follow-up 2))
Blood pressure(2 years (measured at baseline, follow-up 1 and follow-up 2))
Cholesterol(2 years (measured at baseline, follow-up 1 and follow-up 2))
Blood glucose(2 years (measured at baseline, follow-up 1 and follow-up 2))
Hip circumference(2 years (measured at baseline, follow-up 1 and follow-up 2))
SQUASH questionnaire(2 years (measured at baseline, follow-up 1 and follow-up 2))
Pittsburgh Fatigability Scale(2 years (measured at baseline, follow-up 1 and follow-up 2))
SARC-F Sarcopenia Questionnaire(2 years (measured at baseline, follow-up 1 and follow-up 2))
Perceived Stress Scale(2 years (measured at baseline, follow-up 1 and follow-up 2))
MetaMemory in Adulthood (MIA)(2 years (measured at baseline, follow-up 1 and follow-up 2))
Waist circumference(2 years (measured at baseline, follow-up 1 and follow-up 2))
MIND-adjusted Eetscore-FFQ(2 years (measured at baseline, follow-up 1 and follow-up 2))
De Jong Gierveldt Loneliness Scale(2 years (measured at baseline and follow-up 2))
Actigraph (Groningen site only)(2 year (measured for 1 week at baseline, follow-up 1 and follow-up 2))
Physical Activity Record questionnaire (Groningen site only)(2 year (measured for 1 week at baseline, follow-up 1 and follow-up 2))
Height(2 years (measured at baseline, follow-up 1 and follow-up 2))
Weight(2 years (measured at baseline, follow-up 1 and follow-up 2))
Hill-Bone Medication Adherence Scale(2 years (measured at baseline, follow-up 1 and follow-up 2))
Nutritional intake(2 years (measured at baseline, follow-up 1 and follow-up 2))
Pittsburg Sleep Quality Index(2 years (measured at baseline, follow-up 1 and follow-up 2))
Insomnia severity index(2 years (measured at baseline, follow-up 1 and follow-up 2))
p-tau(2 years (measured at baseline and follow-up 2))
NfL(2 years (measured at baseline and follow-up 2))
GFAP(2 years (measured at baseline and follow-up 2))
Lubben Social Network Scale(2 years (measured at baseline, follow-up 1 and follow-up 2))
BDNF(2 years (measured at baseline and follow-up 2))