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Reduction of Adverse Events of Anticholinergic Drugs by Multidisciplinary Medical Reviews in Norwegian Nursing Homes (PRADA)

This study has been completed.
South-Eastern Norway Regional Health Authority
Norwegian Directorate of Health
Information provided by (Responsible Party):
Torgeir Bruun Wyller, Oslo University Hospital Identifier:
First received: February 23, 2009
Last updated: June 18, 2015
Last verified: June 2015

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.

Condition Intervention
Anticholinergic Side Effects
Other: Multidisciplinary drug reviews by pharmacist and physician

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Pharmacist-initiated Reduction of Anticholinergic Drug Activity

Resource links provided by NLM:

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • CERADS word list measuring immediately and delayed recall [ Time Frame: 4 years ]

Secondary Outcome Measures:
  • Mouth dryness [ Time Frame: 4 years ]
  • ADL [ Time Frame: 4 years ]
  • Serum anticholinergic activity [ Time Frame: 4 years ]
  • CERADS word list recognition [ Time Frame: 4 years ]
  • MMSE [ Time Frame: 4 years ]
  • NPI [ Time Frame: 4 years ]

Enrollment: 87
Study Start Date: September 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active treatment arm
Reduction of anticholinergic drug effects by pharmacist review
Other: Multidisciplinary drug reviews by pharmacist and physician
Reduction of anticholinergic drug effects by pharmacist review
No Intervention: Control
No intervention

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.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts 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.
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Please refer to this study by its identifier: NCT00854438

Ullevaal University Hospital
Oslo, Norway, 0407
Sponsors and Collaborators
Ullevaal University Hospital
South-Eastern Norway Regional Health Authority
Norwegian Directorate of Health
Study Director: Torgeir B. Wyller, Professor Ullevaal University Hospital
Principal Investigator: Hege Kersten, MScPharm/PhD Ullevaal University Hospital
  More Information

Responsible Party: Torgeir Bruun Wyller, Professor, Oslo University Hospital Identifier: NCT00854438     History of Changes
Other Study ID Numbers: 1110
Study First Received: February 23, 2009
Last Updated: June 18, 2015

Keywords provided by Oslo University Hospital:
anticholinergic drugs
adverse events
clinical pharmacist
Evaluate the clinical effects of reducing anticholinergic in elderly

Additional relevant MeSH terms:
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on May 24, 2017