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Rivastigmine in the Management of Delirium (confuriv)

This study is currently recruiting participants.
Verified November 2012 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01487317
First received: December 5, 2011
Last updated: November 16, 2012
Last verified: November 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Delirium
 Drug: Rivastigmine transdermal patch
Drug: placebo patch
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
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

Resource links provided by NLM:

MedlinePlus related topics: Delirium
U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients with persistent delirium symptoms (DRS R-98 scale) [ Time Frame: at day 14 ] [ Designated as safety issue: No ]
  • Percentage of patients with persistent delirium symptoms (DRS R-98 scale) [ Time Frame: at day 30 ] [ Designated as safety issue: No ]
  • Percentage of patients with persistent delirium symptoms at day 30 (CAM scale) [ Time Frame: at day 30 ] [ Designated as safety issue: No ]
  • Percentage of patients with a dementia diagnosis at 12 months (according to the DSM IV criteria) [ Time Frame: at 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 440
Study Start Date: June 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Rivastigmine transdermal patch
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
Other Name: placebo patch

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

Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01487317

Contacts
Contact: Marc Verny, MD, PhD + 33 1 42160312 marc.verny@psl.aphp.fr

Locations
France
Pitié Salpetriere Hospital Recruiting
Paris, France, 75013
Contact: Marc Verny, MD, PhD            
Principal Investigator: Marc Verny, MD, PhD            
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Novartis Pharmaceuticals
Investigators
Principal Investigator: Marc Verny, MD, PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01487317     History of Changes
Other Study ID Numbers: P071244, 2009-015632-15
Study First Received: December 5, 2011
Last Updated: November 16, 2012
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Delirium
acetylcholinesterase inhibitor
Elderly
Emergency department

Additional relevant MeSH terms:
Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Cholinesterase Inhibitors
Rivastigmine
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013