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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01633593
Recruitment Status : Terminated (Difficulty in recruiting subjects for the trial.)
First Posted : July 4, 2012
Last Update Posted : May 3, 2018
Information provided by (Responsible Party):
Mario R. Louza, MD, PhD, University of Sao Paulo

Brief Summary:

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 or disease Intervention/treatment Phase
Elderly Delirium of Unknown (Axis III) Etiology Intensive Care (ICU) Myopathy Drug: Donepezil Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Treatment of Delirium in the Elderly With Donepezil: a Double-blind, Randomized, Placebo-controlled Clinical Trial
Study Start Date : August 2012
Actual Primary Completion Date : December 2015
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. reduction of the duration of delirium in elderly patients treated with donepezil [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. Severity of delirium (as measured by the DSR-98-R) may influence the response to donepezil [ Time Frame: 2 weeks ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01633593

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Marilia, Sao Paulo, Brazil, 1750000
Sponsors and Collaborators
University of Sao Paulo
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Principal Investigator: Mario R Louza, MD, PhD University of Sao Paulo
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Responsible Party: Mario R. Louza, MD, PhD, MD, PhD, University of Sao Paulo Identifier: NCT01633593    
Other Study ID Numbers: deliriumBR2012
2010/10810-1 ( Other Grant/Funding Number: Fapesp )
Pfizer ( Other Grant/Funding Number: Pfizer )
First Posted: July 4, 2012    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2018
Additional relevant MeSH terms:
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Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents