Rivastigmine in the Management of Delirium (confuriv)
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||Drug: Rivastigmine transdermal patch Drug: placebo patch||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
|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|
- Hospital length of stay from randomization to declaration by investigator (MD) that patient can leave acute care [ Time Frame: to a maximum of 12 months ]
- Percentage of patients with persistent delirium symptoms (DRS R-98 scale) [ Time Frame: at day 14 ]
- Percentage of patients with persistent delirium symptoms (DRS R-98 scale) [ Time Frame: at day 30 ]
- Percentage of patients with persistent delirium symptoms at day 30 (CAM scale) [ Time Frame: at day 30 ]
- Percentage of patients with a dementia diagnosis at 12 months (according to the DSM IV criteria) [ Time Frame: at 12 months ]
|Study Start Date:||June 2011|
|Study Completion Date:||February 2016|
|Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
|Experimental: Rivastigmine transdermal patch||
Drug: Rivastigmine transdermal patch
One transdermal patch of Rivastigmine (equivalent to 4.6 mg/24h per os) per day from randomization to day 14 before day 14: end od treatment, if DRS R-98 severity < 10 during 2 consecutive days At day 14, if DRS R-98 severity ≥ 10: one transdermal patch of Rivastigmine 9.5 mg/24h per day from day 14 to day 30 if DRS R-98 severity < 10, the active treatment will be stopped
|Placebo Comparator: placebo||
Drug: placebo patch
One transdermal patch of placebo per day from randomization to day 14 Before day 14: end of treatment if DRS R-98 severity < 10 during 2 consecutive days, At day 14 if DRS R-98 severity ≥ 10: One transdermal patch of placebo per day from day 14 to day 30 if DRS R-98 severity < 10, the placebo treatment will be stopped
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
- to assess the efficacy of cholinesterase inhibitors in patients aged 75 and over hospitalized with delirium
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01487317
|Pitié Salpetriere Hospital|
|Paris, France, 75013|
|Principal Investigator:||Marc Verny, MD, PhD||Assistance Publique - Hôpitaux de Paris|