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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2016-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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donepezil

Donepezil 5mg/day during 2 weeks

Group Type EXPERIMENTAL

Donepezil

Intervention Type DRUG

5 mg PO a day, during 2 weeks

placebo

placebo comparator to donepezil (double blind)

Group Type PLACEBO_COMPARATOR

Donepezil

Intervention Type DRUG

5 mg PO a day, during 2 weeks

Interventions

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Donepezil

5 mg PO a day, during 2 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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