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

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

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01633593
Enrollment
19
Registered
2012-07-04
Start date
2012-08-31
Completion date
2016-07-31
Last updated
2018-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DRUGDonepezil

5 mg PO a day, during 2 weeks

Sponsors

University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
reduction of the duration of delirium in elderly patients treated with donepezil2 weeks

Secondary

MeasureTime frame
Severity of delirium (as measured by the DSR-98-R) may influence the response to donepezil2 weeks

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026