Delirium Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled Study of an Acetylcholinesterase Inhibitor in the Management of Delirium in Hospitalized Patients Aged 75 Years and Over
The aim of this study is to evaluate the efficacy of an anticholinesterase treatment in
patients aged 75 and over, hospitalized with delirium.
Study type : Interventional Study design: randomized, double-blind, placebo-controlled study
during one month and a 11-month follow-up
Delirium affects up to 50% of hospitalized patients aged 75 and over. Delirium increases
risk of comorbid illness, hospital length of stay, institutionalization, and death. Patients
with diagnosed or undiagnosed cognitive impairment are at risk to develop delirium. In a
prospective study, half of elderly patients with delirium seen in the emergency department
had cognitive impairment.
Hypothesis: cholinesterase inhibitors reduce duration and severity of delirium
Main objective:
- to assess the efficacy of cholinesterase inhibitors in patients aged 75 and over
hospitalized with delirium
Secondary objectives:
- to describe at one year the percentage of these patients who have a diagnosis of
Alzheimer's disease and associated disorders
- to assess the sensitivity to cholinesterase inhibitors in the sub-group of patients
with a diagnosis of dementia at one year Design and methods Multicenter, randomized,
controlled study with two parallel arms: a rivastigmine group and a placebo group. The
study includes a treatment period of one month and a follow-up of 11 months.
Evaluation of the delirium severity will be conducted with DRS-R98 severity each day during
the hospitalization.
At day 14, according to DRS-R98 severity score, interruption of treatment or upward dose
titration At day 30, last treatment (active or placebo) administration and evaluation with
CAM, DRS-R98 severity, MMSE and DSM IV dementia criteria. In case of dementia diagnosis,
investigator (MD) will identify the etiologic diagnosis.
At month 3 and 12, evaluation with CAM, DRS-R98 severity, MMSE and DSM IV dementia criteria,
number of consultation and hospitalization. In case of dementia diagnosis, , investigator
(MD) will identify the etiologic diagnosis.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
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