Rivastigmine in the Management of Delirium (confuriv)

Assistance Publique - Hôpitaux de Paris

Status and phase

Completed

Phase 3

Conditions

Delirium

Treatments

Drug: placebo patch

Drug: Rivastigmine transdermal patch

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01487317

2009-015632-15 (EudraCT Number)

P071244

Details and patient eligibility

About

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

Full 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.

Enrollment

23 patients

Sex

All

Ages

75+ years old

Volunteers

No Healthy Volunteers

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