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Treatment of Delirium in the Elderly With Donepezil: a Double-blind, Randomized, Placebo-controlled Clinical Trial

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2012 by University of Sao Paulo
Sponsor:
Information provided by (Responsible Party):
Mario R. Louza, MD, PhD, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01633593
First received: June 29, 2012
Last updated: July 3, 2012
Last verified: June 2012
  Purpose

Nowadays features for the diagnosis of delirium are:

  1. Disturbance of consciousness (i.e. reduced clarity of environment awareness) with reduced ability to focus, sustain or shift attention;
  2. A change in cognition (such as memory deficit, disorientation, language disturbance) or the development of a perceptual disturbance that is not better accounted for by a pre-existing or evolving dementia;
  3. The disturbance develops over a short period of time (usually hours to days) and its severity fluctuates during the course of the day;
  4. There is evidence from the history, physical examination, or laboratory findings that the disorder is caused by the direct physiological consequences of a general medical condition, substance intoxication or substance withdrawal.

Treatment of underlying clinical disease is important to remit the delirium. However, these procedures alone are not enough to remit the delirium early and to prevent sequels. There is a need for a specific and faster strategy to treat the delirium.

The investigators want to test the hypothesis that an Anticholinesterase Inhibitor (donepezil) can reduce the duration of the delirium.


Condition Intervention Phase
Elderly
Delirium of Unknown (Axis III) Etiology
Intensive Care (ICU) Myopathy
Drug: Donepezil
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Treatment of Delirium in the Elderly With Donepezil: a Double-blind, Randomized, Placebo-controlled Clinical Trial

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • reduction of the duration of delirium in elderly patients treated with donepezil [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Severity of delirium (as measured by the DSR-98-R) may influence the response to donepezil [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 190
Study Start Date: August 2012
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: donepezil
Donepezil 5mg/day during 2 weeks
Drug: Donepezil
5 mg PO a day, during 2 weeks
Placebo Comparator: placebo
placebo comparator to donepezil (double blind)
Drug: Donepezil
5 mg PO a day, during 2 weeks

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Over 60 year old
  • Delirium according to the CAM-ICU (Confusion Assessment Method for Intensive Care Unit)
  • informed consent (legal representatives)

Exclusion Criteria:

  • unable to swallow pills
  • previous allergy to donepezil
  • Atrioventricular block of 2nd and 3nd degree
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Mario R. Louza, MD, PhD, MD, PhD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01633593     History of Changes
Other Study ID Numbers: deliriumBR2012, 2010/10810-1, Pfizer
Study First Received: June 29, 2012
Last Updated: July 3, 2012
Health Authority: Brazil: Ethics Committee

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

ClinicalTrials.gov processed this record on November 24, 2014