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Your journey
1What's a trial
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More info
You can access this
clinical trial
if you have
Polypharmacy, Anticholinergics, Hypnotics and Sedatives, Cognitive Function or Physical Function
and you are
over 55
years old
This is an observational trial.
You are contributing to medical knowledge about your condition.
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The purpose

Anticholinergic and sedative drugs are frequently prescribed to older people, despite their negative impact on older people's physical and cognitive function. To estimate the cumulative exposure to anticholinergic and sedative drugs, Hilmer et al. published the Drug Burden Index (DBI) in 2007. The present study aims to complement previous study findings showing higher DBI values to be associated with physical and cognitive impairment. Most previously conducted studies of the DBI were either cross-sectional or were longitudinal but with short follow-ups. Furthermore, it remains unknown whether higher DBI values carry extra risks for patients with dementia. Finally, relatively little is known about the stability of DBI values over time. The current project therefore aims to examine (1) longitudinal relationships between long-term cumulative exposure to anticholinergic and sedative drugs as measured with the DBI and cognitive and physical function, (2) to examine interaction effects between DBI exposure and dementia, and (3) to examine trajectories of DBI exposure, i.e. DBI exposure remaining stable, declining, increasing or fluctuating over time. These project aims will be studied with longitudinal data from eligible participants > 60 years from the LASA study with participants being followed-up during two decades, and the longitudinal data from the InterRAI consortium. Various clinical outcomes regarding cognitive and physical function will be studied. Data will be analysed with generalised linear mixed models and Latent Class Growth Analysis.

Locations near you

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Tris trial is registered with FDA with number: NCT03024541. The sponsor of the trial is University of Groningen and it is looking for 9985 volunteers for the current phase.
Official trial title:
Longitudinal Analysis of Cumulative Exposure to Anticholinergic and Sedative Drugs Measured With the Drug Burden Index