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

Elderly Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01633593
• Other study ID #: deliriumBR2012
• Secondary ID: 2010/10810-1Pfiz
• Status: Terminated
• Phase: Phase 4
• Start date: August 2012
• Est. completion date: July 2016

Study information

• Verified date: May 2018
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: July 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Delirium of Unknown (Axis III) Etiology
• Elderly
• Intensive Care (ICU) Myopathy

Intervention

Drug:
• Donepezil
5 mg PO a day, during 2 weeks

Locations

Country	Name	City	State
Brazil	FAMEMA	Marilia	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reduction of the duration of delirium in elderly patients treated with donepezil		2 weeks
Secondary	Severity of delirium (as measured by the DSR-98-R) may influence the response to donepezil		2 weeks