Rivastigmine in the Management of Delirium

NCT ID: NCT01487317

Last Updated: 2016-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2016-02-29

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.

Conditions

Delirium

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Rivastigmine transdermal patch

Group Type: EXPERIMENTAL

Rivastigmine transdermal patch

Intervention Type: DRUG

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

Group Type: PLACEBO_COMPARATOR

placebo patch

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

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

• Minimum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marc Verny, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Pitié Salpetriere Hospital

Paris, , France

Countries

France

Other Identifiers

2009-015632-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

P071244

Identifier Type: -

Identifier Source: org_study_id