ElderlyPhase 4NCT01633593
Treatment of Delirium in the Elderly With Donepezil: a Double-blind, Randomized, Placebo-controlled Clinical Trial
A Phase 4 study testing Donepezil in people with Elderly and Delirium of Unknown (Axis III) Etiology, run by University of Sao Paulo at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Elderly, Delirium of Unknown (Axis III) Etiology, Intensive Care (ICU) Myopathy
- What is being tested?
- Donepezil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2012to Jul 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 60 year old
- Delirium according to the CAM-ICU (Confusion Assessment Method for Intensive Care Unit)
- informed consent (legal representatives)
Who cannot join
- unable to swallow pills
- previous allergy to donepezil
- Atrioventricular block of 2nd and 3nd degree
Trial locations and contacts
1 site in 1 country.
About this study
Nowadays features for the diagnosis of delirium are:
- Disturbance of consciousness (i.e. reduced clarity of environment awareness) with reduced ability to focus, sustain or shift attention;
- 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;
- The disturbance develops over a short period of time (usually hours to days) and its severity fluctuates during the course of the day;
- 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.
Read more
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.
- Being tested
- Donepezil
- Medical subject headings
- Muscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DonepezilDrug
5 mg PO a day, during 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| donepezil | Experimental | Donepezil 5mg/day during 2 weeks Receives: Drug: Donepezil |
| placebo | Placebo comparator | placebo comparator to donepezil (double blind) Receives: Drug: Donepezil |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction of the duration of delirium in elderly patients treated with donepezil
Measured: 2 weeks
Secondary outcomes (1)
Severity of delirium (as measured by the DSR-98-R) may influence the response to donepezil
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2012 (estimated)
- Study startAug 2012
- Primary completionDec 2015
- Study completionJul 2016
Why it stopped: Difficulty in recruiting subjects for the trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderlyStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mario R. Louza, MD, PhD, University of Sao Paulo
- Investigators
- Mario R Louza, MD, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01633593
- Sponsor's protocol ID
- deliriumBR2012
- Other IDs
- 2010/10810-1, Pfizer
- Status last verified
- May 2018
- First submitted
- 29 Jun 2012
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Delirium in the Elderly With Donepezil: a Double-blind, Randomized, Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT01633593
- Acronym / sponsor ID
- deliriumBR2012
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty in recruiting subjects for the trial.
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 4 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Nowadays features for the diagnosis of delirium are:
- Disturbance of consciousness (i.e. reduced clarity of environment awareness) with reduced ability to focus, sustain or shift attention;
- 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;
- The disturbance develops over a short period of time (usually hours to days) and its severity fluctuates during the course of the day;
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| donepezil | Experimental | Drug: DonepezilDonepezil 5mg/day during 2 weeks |
| placebo | Placebo comparator | Drug: Donepezilplacebo comparator to donepezil (double blind) |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 60 year old
- Delirium according to the CAM-ICU (Confusion Assessment Method for Intensive Care Unit)
- informed consent (legal representatives)
Key exclusion criteria (3 listed)
- unable to swallow pills
- previous allergy to donepezil
- Atrioventricular block of 2nd and 3nd degree
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Donepezil5 mg PO a day, during 2 weeks | Drug | donepezil, placebo |
Primary outcome
reduction of the duration of delirium in elderly patients treated with donepezil
Time frame: 2 weeks
1 secondary outcome
Severity of delirium (as measured by the DSR-98-R) may influence the response to donepezil
Time frame: 2 weeks
Results and safety
The study was stopped early (reason given: Difficulty in recruiting subjects for the trial.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mario R Louza, MD, PhD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Donepezil in people with Elderly and Delirium of Unknown (Axis III) Etiology, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Difficulty in recruiting subjects for the trial.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction of the duration of delirium in elderly patients treated with donepezil (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2018.