Pharmacist-initiated Reduction of Anticholinergic Drug Activity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 87
- 试验地点
- 2
- 主要终点
- CERADS word list measuring immediately and delayed recall
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Not able to perform the testes because of physical or psychiatric illnesses.
结局指标
主要结局
CERADS word list measuring immediately and delayed recall
时间窗: 4 years
次要结局
- ADL(4 years)
- Serum anticholinergic activity(4 years)
- NPI(4 years)
- CERADS word list recognition(4 years)
- MMSE(4 years)
- Mouth dryness(4 years)
研究者
Torgeir Bruun Wyller
Professor
Oslo University Hospital