AgeWell.de – a pragmatic multi-centric cluster-randomized controlled prevention trial against cognitive decline in older primary care patients

Background:

In the absence of treatment options, identification of effective prevention strategies is a key element to counteract the dementia epidemic. Due to the complex nature of dementia, trials targeting multiple risk factors should be particularly effective. So far, only few such multi-component trials have been launched, but yielding promising results. In Germany, comparable studies are lacking. AgeWell.de will be conducted as the first multi-component prevention trial in Germany.

Methods:

Study design: multi-centric, cluster-randomized controlled multi-component prevention trial. Participants: 1,152 community-dwelling GP patients (60 – 77 years) with increased dementia risk, recruited at 5 study sites across Germany. GP practices will be randomized to intervention A (nutritional counseling, physical activity, cognitive training, optimization of medication, management of vascular risk factors, social activity; if necessary, interventions targeting grief and depression) or B (general health advice on the intervention components, GP treatment as usual). We hypothesize that over the 2-year follow-up period, intervention group A will benefit significantly from the intervention in terms of preserved cognitive function/delayed cognitive decline (primary outcome) and other secondary outcomes (e.g. quality of life, social activities, depressive symptomatology).

Results and discussion:

Compared to previous trials, AgeWell.de covers an even broader set of interventions suggested to be beneficial for the intended outcomes. The findings will add substantial knowledge on modifiable lifestyle factors to prevent/delay cognitive decline. We aim to implement the intervention, if effective, in real world settings. Thereby, AgeWell.de could add to targeted and cost-effective strategies in preventing dementia in older adults at risk.