DeliriumPhase 3confurivNCT01487317
Rivastigmine in the Management of Delirium
A Phase 3 study testing Rivastigmine transdermal patch in people with Delirium, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The aim of this study is to evaluate the efficacy of an anticholinesterase treatment in patients aged 75 and over, hospitalized with delirium. Study type : Interventional Study design: randomized, double-blind, placebo-controlled study during one month and a 11-month follow-up Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Delirium
- What is being tested?
- Rivastigmine transdermal patch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2011to Feb 2016
- Phase
- Phase 3
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients aged 75 and over
- Hospitalization for delirium not correlated to surgery for less than 48 hours
- Patients with delirium requiring the presence of features 1 (acute onset and fluctuation course), 2 (inattention), 3 (disorganized thinking) and 4 (altered level of consciousness) of the Confusion Assessment Model and DRS R-98 > 10
- Absence of any contraindications to a cholinesterase inhibitor treatment
- Health insurance affiliation
- Having signed an informed consent form
- Caregiver/informant to provide information on patient
Who cannot join
- Use of IAchE or memantine medication
- Contraindication to IAchE medication
- Frontotemporal dementia
- Diseases involving the short-term survival
- Digestive bleeding
- Ischemic and hemorrhagic stroke related to actual onset (including hemorrhagic contusion)
Show all 14Show fewer
- Natremia ≤120 mmol/l at the time of hospitalization
- Post epileptic confusion
- Hepato-cellular failure
- Cardiorespiratory impairment at risk of transfer to intensive care unit
- Major sensory deficits that could interfere with cognitive assessment (visual and auditory)
- Not fluent in French
- Being under guardianship
- Absence of caregiver/informant to sign informed consent form
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study of an Acetylcholinesterase Inhibitor in the Management of Delirium in Hospitalized Patients Aged 75 Years and Over
The aim of this study is to evaluate the efficacy of an anticholinesterase treatment in patients aged 75 and over, hospitalized with delirium.
Study type : Interventional Study design: randomized, double-blind, placebo-controlled study during one month and a 11-month follow-up
Read the detailed description
Delirium affects up to 50% of hospitalized patients aged 75 and over. Delirium increases risk of comorbid illness, hospital length of stay, institutionalization, and death. Patients with diagnosed or undiagnosed cognitive impairment are at risk to develop delirium. In a prospective study, half of elderly patients with delirium seen in the emergency department had cognitive impairment.
Hypothesis: cholinesterase inhibitors reduce duration and severity of delirium
Main objective:
- to assess the efficacy of cholinesterase inhibitors in patients aged 75 and over hospitalized with delirium
Secondary objectives:
- to describe at one year the percentage of these patients who have a diagnosis of Alzheimer's disease and associated disorders
- to assess the sensitivity to cholinesterase inhibitors in the sub-group of patients with a diagnosis of dementia at one year Design and methods Multicenter, randomized, controlled study with two parallel arms: a rivastigmine group and a placebo group. The study includes a treatment period of one month and a follow-up of 11 months.
Evaluation of the delirium severity will be conducted with DRS-R98 severity each day during the hospitalization.
At day 14, according to DRS-R98 severity score, interruption of treatment or upward dose titration At day 30, last treatment (active or placebo) administration and evaluation with CAM, DRS-R98 severity, MMSE and DSM IV dementia criteria. In case of dementia diagnosis, investigator (MD) will identify the etiologic diagnosis.
At month 3 and 12, evaluation with CAM, DRS-R98 severity, MMSE and DSM IV dementia criteria, number of consultation and hospitalization. In case of dementia diagnosis, , investigator (MD) will identify the etiologic diagnosis.
- Conditions
- Delirium
- Being tested
- Rivastigmine transdermal patch, placebo patch
- Keywords
- Delirium, acetylcholinesterase inhibitor, Elderly, Emergency department
- Medical subject headings
- Delirium, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivastigmine transdermal patchDrug
One transdermal patch of Rivastigmine (equivalent to 4.6 mg/24h per os) per day from randomization to day 14 before day 14: end od treatment, if DRS R-98 severity < 10 during 2 consecutive days At day 14, if DRS R-98 severity ≥ 10: one transdermal patch of Rivastigmine 9.5 mg/24h per day from day 14 to day 30 if DRS R-98 severity < 10, the active treatment will be stopped
placebo patchDrug
One transdermal patch of placebo per day from randomization to day 14 Before day 14: end of treatment if DRS R-98 severity < 10 during 2 consecutive days, At day 14 if DRS R-98 severity ≥ 10: One transdermal patch of placebo per day from day 14 to day 30 if DRS R-98 severity < 10, the placebo treatment will be stopped
| Study group | Role | What they receive |
|---|---|---|
| Rivastigmine transdermal patch | Experimental | Not described Receives: Drug: Rivastigmine transdermal patch |
| placebo | Placebo comparator | Not described Receives: Drug: placebo patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital length of stay from randomization to declaration by investigator (MD) that patient can leave acute care
Measured: to a maximum of 12 months
Secondary outcomes (4)
Percentage of patients with persistent delirium symptoms (DRS R-98 scale)
Measured: at day 14
Percentage of patients with persistent delirium symptoms (DRS R-98 scale)
Measured: at day 30
Percentage of patients with persistent delirium symptoms at day 30 (CAM scale)
Measured: at day 30
Percentage of patients with a dementia diagnosis at 12 months (according to the DSM IV criteria)
Measured: at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2011 (estimated)
- Study startJun 2011
- Primary completionAug 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Marc Verny, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01487317
- Sponsor's protocol ID
- P071244
- Other IDs
- 2009-015632-15, 2009
- Acronym
- confuriv
- Status last verified
- Jul 2016
- First submitted
- 5 Dec 2011
- Last updated
- 20 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study of an Acetylcholinesterase Inhibitor in the Management of Delirium in Hospitalized Patients Aged 75 Years and Over
- ClinicalTrials.gov ID
- NCT01487317
- Acronym / sponsor ID
- confuriv / P071244
- Conditions
- Delirium
- Keywords
- Delirium, acetylcholinesterase inhibitor, Elderly, Emergency department
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Jun 2011
- Primary completion
- Aug 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 7 Dec 2011 (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.
The aim of this study is to evaluate the efficacy of an anticholinesterase treatment in patients aged 75 and over, hospitalized with delirium.
Study type : Interventional Study design: randomized, double-blind, placebo-controlled study during one month and a 11-month follow-up
Detailed description
Delirium affects up to 50% of hospitalized patients aged 75 and over. Delirium increases risk of comorbid illness, hospital length of stay, institutionalization, and death. Patients with diagnosed or undiagnosed cognitive impairment are at risk to develop delirium. In a prospective study, half of elderly patients with delirium seen in the emergency department had cognitive impairment.
Hypothesis: cholinesterase inhibitors reduce duration and severity of delirium
Main objective:
- to assess the efficacy of cholinesterase inhibitors in patients aged 75 and over hospitalized with delirium
Secondary objectives:
- to describe at one year the percentage of these patients who have a diagnosis of Alzheimer's disease and associated disorders
- to assess the sensitivity to cholinesterase inhibitors in the sub-group of patients with a diagnosis of dementia at one year Design and methods Multicenter, randomized, controlled study with two parallel arms: a rivastigmine group and a placebo group. The study includes a treatment period of one month and a follow-up of 11 months.
Evaluation of the delirium severity will be conducted with DRS-R98 severity each day during the hospitalization.
At day 14, according to DRS-R98 severity score, interruption of treatment or upward dose titration At day 30, last treatment (active or placebo) administration and evaluation with CAM, DRS-R98 severity, MMSE and DSM IV dementia criteria. In case of dementia diagnosis, investigator (MD) will identify the etiologic diagnosis.
At month 3 and 12, evaluation with CAM, DRS-R98 severity, MMSE and DSM IV dementia criteria, number of consultation and hospitalization. In case of dementia diagnosis, , investigator (MD) will identify the etiologic diagnosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rivastigmine transdermal patch | Experimental | Drug: Rivastigmine transdermal patch |
| placebo | Placebo comparator | Drug: placebo patch |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Patients aged 75 and over
- Hospitalization for delirium not correlated to surgery for less than 48 hours
- Patients with delirium requiring the presence of features 1 (acute onset and fluctuation course), 2 (inattention), 3 (disorganized thinking) and 4 (altered level of consciousness) of the Confusion Assessment Model and DRS R-98 > 10
- Absence of any contraindications to a cholinesterase inhibitor treatment
- Health insurance affiliation
Key exclusion criteria (14 listed)
- Use of IAchE or memantine medication
- Contraindication to IAchE medication
- Frontotemporal dementia
- Diseases involving the short-term survival
- Digestive bleeding
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 |
|---|---|---|
| Rivastigmine transdermal patchOne transdermal patch of Rivastigmine (equivalent to 4.6 mg/24h per os) per day from randomization to day 14 before day 14: end od treatment, if DRS R-98 severity < 10 during 2 consecutive days At day 14, if DRS R-98 severity ≥ 10: one transdermal patch of Rivastigmine 9.5 mg/24h per day from day 14 to day 30 if DRS R-98 severity < 10, the active treatment will be stopped | Drug | Rivastigmine transdermal patch |
| placebo patchOne transdermal patch of placebo per day from randomization to day 14 Before day 14: end of treatment if DRS R-98 severity < 10 during 2 consecutive days, At day 14 if DRS R-98 severity ≥ 10: One transdermal patch of placebo per day from day 14 to day 30 if DRS R-98 severity < 10, the placebo treatment will be stopped | Drug | placebo |
Primary outcome
Hospital length of stay from randomization to declaration by investigator (MD) that patient can leave acute care
Time frame: to a maximum of 12 months
4 secondary outcomes
Percentage of patients with persistent delirium symptoms (DRS R-98 scale)
Time frame: at day 14
Percentage of patients with persistent delirium symptoms (DRS R-98 scale)
Time frame: at day 30
Percentage of patients with persistent delirium symptoms at day 30 (CAM scale)
Time frame: at day 30
Percentage of patients with a dementia diagnosis at 12 months (according to the DSM IV criteria)
Time frame: at 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2016.
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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.
Marc Verny, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rivastigmine transdermal patch in people with Delirium, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 7 inclusion and 14 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: finished, as of the sponsor's last update on 20 Jul 2016. 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 France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Hospital length of stay from randomization to declaration by investigator (MD) that patient can leave acute care (time frame: to a maximum of 12 months). 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 20 Jul 2016.