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

NCT01633593 | Terminated Phase 4

• 3 other identifiers: deliriumBR20122010/10810-1Pfizer
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

Nowadays features for the diagnosis of delirium are:

1. 1.Disturbance of consciousness (i.e. reduced clarity of environment awareness) with reduced ability to focus, sustain or shift attention;
2. 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. 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. 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• reduction of the duration of delirium in elderly patients treated with donepezil

  2 weeks

Secondary Outcomes (1)

• Severity of delirium (as measured by the DSR-98-R) may influence the response to donepezil

  2 weeks

Study Arms (2)

donepezil

EXPERIMENTAL

Donepezil 5mg/day during 2 weeks

Drug: Donepezil

placebo

PLACEBO COMPARATOR

placebo comparator to donepezil (double blind)

Drug: Donepezil

Interventions

Donepezil DRUG

5 mg PO a day, during 2 weeks

donepezil; placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• unable to swallow pills
• previous allergy to donepezil
• Atrioventricular block of 2nd and 3nd degree

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

FAMEMA

Marília, São Paulo, 1750000, Brazil

Location

MeSH Terms

Conditions

Muscular Diseases

Interventions

Donepezil

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• Mario R Louza, MD, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: June 29, 2012
• First Posted: July 4, 2012
• Study Start: August 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: July 1, 2016
• Last Updated: May 3, 2018

Record last verified: 2018-05

Locations

BR (1)