Skip to content

Dutch multidomain lifestyle intervention in older adults at risk of cognitive decline

Dutch multidomain lifestyle intervention in older adults at risk of cognitive decline

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON21543
Enrollment
1206
Registered
2021-07-28
Start date
2022-02-09
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitively normal adults with risk factors for cognitive decline

Interventions

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 interventi
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.

Sponsors

Amsterdam UMC, location VU Medical Center (VUmc)
Lead Sponsor

Eligibility

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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 (Aß42/40, p-tau), axonal damage (NfL), astrocytes activity/injury or stress (GFAP) and brain plasticity (BDNF).

Contacts

Public ContactMarissa Zwan

Amsterdam UMC

m.zwan@amsterdamumc.nl020-44440685

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)