Anticholinergic Side Effects
Conditions
Keywords
anticholinergic drugs, adverse events, elderly, clinical pharmacist, Evaluate the clinical effects of reducing anticholinergic in elderly
Brief summary
Thesis: Is drug-induced anticholinergic activity additive resulting in a total anticholinergic load causing harmful side effects in old, fragile patients? Is it possible to reduce the anticholinergic load by multidisciplinary medical review including a pharmacist and a physician? The effects of the medical reviews are measured by cognitive tests (MMS and CERADS word lists), a measure of mouth dryness, serum levels of anticholinergic activity, activity of daily living and neuropsychiatric symptoms. Design: A randomized, controlled, single blinded interventional study in Norwegian nursing homes.
Detailed description
Several studies have claimed that drugs showing anticholinergic activity in vitro cause high levels of serum anticholinergic activity in vivo that might cause impaired cognitive and functional functions in elderly. Pathophysiological changes in Alzheimer's dementia makes these patients particularly vulnerable for anticholinergic cognitive impairments. The PRADA-study is the first interventional study evaluating the clinical effects of reducing drug-induced anticholinergic load in patients with dementia. This is also the first interventional study in the Nordic countries evaluating the clinical effects of clinical pharmacy.
Interventions
OTHERMultidisciplinary drug reviews by pharmacist and physician
Reduction of anticholinergic drug effects by pharmacist review
Sponsors
South-Eastern Norway Regional Health Authority
Norwegian Directorate of Health
Ullevaal University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Long-term nursing home patients with none, mild or moderate dementia (evaluated by CDR9,using drugs with a total anticholinergic burden that might lead to adverse events.
Exclusion criteria
* Not able to perform the testes because of physical or psychiatric illnesses.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CERADS word list measuring immediately and delayed recall | 4 years |
Secondary
| Measure | Time frame |
|---|---|
| ADL | 4 years |
| Serum anticholinergic activity | 4 years |
| Mouth dryness | 4 years |
| MMSE | 4 years |
| NPI | 4 years |
| CERADS word list recognition | 4 years |
Countries
Norway
Outcome results
None listed