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

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.

Study Overview

• Status: Terminated
• Conditions: Elderly; Delirium of Unknown (Axis III) Etiology; Intensive Care (ICU) Myopathy
• Intervention / Treatment: Drug: Donepezil

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo
    • Marilia, Sao Paulo, Brazil, 1750000
      • FAMEMA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
reduction of the duration of delirium in elderly patients treated with donepezil	2 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Severity of delirium (as measured by the DSR-98-R) may influence the response to donepezil	2 weeks

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Investigators: Principal Investigator: Mario R Louza, MD, PhD, University of Sao Paulo

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: June 29, 2012
• First Submitted That Met QC Criteria: July 3, 2012
• First Posted (Estimate): July 4, 2012

Study Record Updates

• Last Update Posted (Actual): May 3, 2018
• Last Update Submitted That Met QC Criteria: May 2, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Enzyme Inhibitors; Nootropic Agents; Cholinesterase Inhibitors; Donepezil
• Other Study ID Numbers: deliriumBR2012; Pfizer (Pfizer); 2010/10810-1 (Other Grant/Funding Number: Fapesp)