Clinical trial NCT01487317: Rivastigmine in the Management of Delirium
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Delirium
Keywords: Delirium
acetylcholinesterase inhibitor
Elderly
Emergency department
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Novartis Pharmaceuticals
First posted: 2011-12-07
Enrollment: 23
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients aged 75 and over
* Hospitalization for delirium not correlated to surgery for less than 48 hours
* Patients with delirium requiring the presence of features 1 (acute onset and fluctuation course), 2 (inattention), 3 (disorganized thinking) and 4 (altered level of consciousness) of the Confusion Assessment Model and DRS R-98 \> 10
* Absence of any contraindications to a cholinesterase inhibitor treatment
* Health insurance affiliation
* Having signed an informed consent form
* Caregiver/informant to provide information on patient

Exclusion Criteria:

* Use of IAchE or memantine medication
* Contraindication to IAchE medication
* Frontotemporal dementia
* Diseases involving the short-term survival
* Digestive bleeding
* Ischemic and hemorrhagic stroke related to actual onset (including hemorrhagic contusion)
* Natremia ≤120 mmol/l at the time of hospitalization
* Post epileptic confusion
* Hepato-cellular failure
* Cardiorespiratory impairment at risk of transfer to intensive care unit
* Major sensory deficits that could interfere with cognitive assessment (visual and auditory)
* Not fluent in French
* Being under guardianship
* Absence of caregiver/informant to sign informed consent form

Primary outcomes:
measure: Hospital length of stay from randomization to declaration by investigator (MD) that patient can leave acute care
timeFrame: to a maximum of 12 months
Secondary outcomes:
measure: Percentage of patients with persistent delirium symptoms (DRS R-98 scale)
timeFrame: at day 14
measure: Percentage of patients with persistent delirium symptoms (DRS R-98 scale)
timeFrame: at day 30
measure: Percentage of patients with persistent delirium symptoms at day 30 (CAM scale)
timeFrame: at day 30
measure: Percentage of patients with a dementia diagnosis at 12 months (according to the DSM IV criteria)
timeFrame: at 12 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Pitié Salpetriere Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Marc Verny, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: