Dutch multidomain lifestyle intervention in older adults at risk of cognitive decline
Recruiting
- Conditions
- Cognitively normal adults with risk factors for cognitive decline
- Registration Number
- NL-OMON21543
- Lead Sponsor
- Amsterdam UMC, location VU Medical Center (VUmc)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 1206
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method 2-year change from baseline in:<br>a) individual cognitive test performances, representing memory, processing speed and attention and executive functioning;<br>b) Instrumental activities of daily living;<br>c) Quality of life;<br>d) Modifiable dementia risk;<br>e) Intervention specific outcomes<br>f) Blood-based biomarkers for Alzheimer’s disease (Aß42/40, p-tau), axonal damage (NfL), astrocytes activity/injury or stress (GFAP) and brain plasticity (BDNF).