Neurocognitive DisordersPhase 2MIRAGENCT06638710
Efficacy and Safety of Oral Midazolam Used for the Delivery of Care in Elderly Patient With Neurocognitive Disorders and Refusing Care.
A Phase 2 study of Neurocognitive Disorders, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The purpose of this study is to assess the effectiveness of oral midazolam on the delivery of care in elderly patients with moderat to severe neurocognitive disorders and opposing care. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Neurocognitive Disorders
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jul 2025to 1 Nov 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Patient hospitalized (for a minimum estimated duration of 21 days) in a geriatric department in Medical Care and Rehabilitation, Cognitive-Behavioral Unit, or housed in a Reinforced Housing Unit, in a Long-Term Care Unit, or in a Psycho-Geriatric Unit.
- Moderate to severe cognitive impairment, defined by a MMSE (Mini Mental State Examination) score \<15. If not feasible at inclusion, MMSE score \<15 less than 1 year old.
- Patient opposed to care, presenting at least two episodes of opposition to care (meals excluded) for which other non-medication alternatives have failed. These refusals of care are defined by a \"resistance to care\" score ≥3 on the Pittsburgh scale, over the last week. In practice, the resistance to care of patients is noted in the medical record following a weekly multidisciplinary decision.
- The targeted cares:
- Essential nursing care (indispensable, mandatory, and prescribed) Bathing and changing made essential by obvious lack of hygiene after evaluation Bedtime installation (e.g., with the SECURIDRAP® device) technical care: blood tests, wound care, dressing changes, insertion of urinary or nasogastric tubes; administration of medication by parenteral route
- Person affiliated with social security or beneficiary of such a scheme
- Informed, written, and signed consent by the patient or their legal representative (for adults under legal protection and unable to express their consent)
Who cannot join
- Patient who has received midazolam treatment in the week before inclusion
- Patient with contraindications to midazolam:
- severe Myasthenia Severe respiratory failure requiring continuous oxygen therapy Severe liver failure: PT \<50% Severe sleep apnea syndrome not treated with a device Severe renal failure: Cockcroft \<20mL/min Severe heart failure in a state of decompensation History of alcoholism or drug addiction
- Known hypersensitivity to the active substance, benzodiazepines, or any of the excipients
- Patient being treated concurrently with:
- CYP3A4 enzyme inhibitors CYP3A4 enzyme inducers
Show all 13Show fewer
- Weight \<50 kg and \>100 kg
- Gastrointestinal pathology that may limit or prevent the absorption of midazolam
- Identification of anxiety, defined by item E of the NPI (neuropsychiatric inventory) by an evaluation \>2 in frequency and severity according to HAS recommendations.
- Identification of pain, defined by the Algoplus scale by an evaluation ≥2
- Identification of ideational disorders, defined by item E of the Cornell scale: E\>0
- Subject in the exclusion period of another clinical trial
- Subject deprived of liberty by an administrative or judicial decision.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Geriatric department of Grenoble Alpes university hospital
Grenoble, Isere, 38043
Virginie GARNIER, MD, 0476767575 ext. +33, VGarnier@chu-grenoble.fr
About this study
Official title: Efficacy and Safety of Oral Midazolam for the Delivery of Care in Elderly Patient With Moderate to Severe Neurocognitive Disorders and Refusing Care
The purpose of this study is to assess the effectiveness of oral midazolam on the delivery of care in elderly patients with moderat to severe neurocognitive disorders and opposing care.
Read the detailed description
Neurodegenerative disorders may lead to behavioral disturbances that can result in oppositional reactions, making the performance of certain medical treatments complex.
Midazolam is used to reduce anxiety and agitation in elderly patients with moderate to severe neurocognitive disorders. It has the advantages of rapid action, short half-life, and good tolerability. A recent study shows that its use by subcutaneous (SC) injection 'as needed,' off-label, is becoming increasingly common in elderly patients, particularly to facilitate care. However, SC injection may be poorly tolerated by patients, difficult to administer, and may cause a feeling of mistreatment.
The aim of this clinical trial is to evaluate the efficacy and safety of an oral form of midazolam adapted for the elderly on the performance of care.
- Conditions
- Neurocognitive Disorders
- Being tested
- oral administration of midazolam or placebo
- Keywords
- elderly, midazolam, care
- Medical subject headings
- Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral administration of midazolam or placeboDrug
If the patient is opposed to a treatment (resistance to care ≥3 on the Pittsburgh scale), the nurse administers an oral dose of midazolam or placebo to the patient according to the random allocation.
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | The nurse administers an oral dose of placebo to the patient Receives: Drug: oral administration of midazolam or placebo |
| oral midazolam | Experimental | The nurse administers an oral dose of midazolam to the patient Receives: Drug: oral administration of midazolam or placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of resistance to care following oral administration of midazolam
The efficacy will be evaluated by a decrease of at least two points in the resistance to care dimension of the Pittsburgh scale. the care dimension scale has 4 points, 4 is the worst score, 0 is the better.
Measured: For each care: change of the care dimension of the Pittsburgh scale from the time of intention of care and 30 to 45 minutes after the study treatment intake.
Secondary outcomes (4)
effectiveness of oral midazolam in terms of acceptance of care
The acceptance of care is evaluated using the care acceptance scale by Rignell et al. (2007). This scale rangin from 1 to 4. the wrongest score is.
Measured: For each care : This scale is measured immédiately after the end of the care.
Evolution of agitation and refusal to care following oral administration of midazolam
Agitation and refusal of care will be evaluated using the global score of the Pittsburgh Agitation Scale. The scale ranging from 0 to 16. the wrongest score is 16
Measured: For each care: change from the time of intention of care and 30 to 45 minutes after the study treatment intake.
Number and description of Treatment-Related Adverse Events.
Measurement of saturation, respiratory rate, and heart rate, and collection of serious and non-serious adverse events occurring after the administration of midazolam gel.
Measured: From enrollment to the end of treatment at 4 months
Satisfaction of the caregiving staff.
Satisfaction questionnaire on the caregivers; sense of well-being towards patients.
Measured: For each care: immediatly after the care.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start8 Jul 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurocognitive DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a \"n of one design\" study * Patients presenting opposition to at least two nursing care will be selected for the study. * Patients included in the study will be assigned a kit of 20 unit doses containing an oral gel of midazolam or placebo, according to a predefined sequence. Maximum 20 nursing care will be included in the study. * For each new opposition to treatment ≥ 3 on the Pittsburgh scale, the nurse will administer the next syringe from the kit in a double-blind manner, following the predefined order. Thirty to forty minutes after administration, the nurse will reassess the level of opposition and then attempt the same care again.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06638710
- Sponsor's protocol ID
- 38RC21.0436
- Acronym
- MIRAGE
- Status last verified
- Dec 2025
- First submitted
- 10 Sep 2024
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Oral Midazolam for the Delivery of Care in Elderly Patient With Moderate to Severe Neurocognitive Disorders and Refusing Care
- ClinicalTrials.gov ID
- NCT06638710
- Acronym / sponsor ID
- MIRAGE / 38RC21.0436
- Conditions
- Neurocognitive Disorders
- Keywords
- elderly, midazolam, care
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 8 Jul 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 15 Oct 2024 (actual)
- 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 purpose of this study is to assess the effectiveness of oral midazolam on the delivery of care in elderly patients with moderat to severe neurocognitive disorders and opposing care.
Detailed description
Neurodegenerative disorders may lead to behavioral disturbances that can result in oppositional reactions, making the performance of certain medical treatments complex.
Midazolam is used to reduce anxiety and agitation in elderly patients with moderate to severe neurocognitive disorders. It has the advantages of rapid action, short half-life, and good tolerability. A recent study shows that its use by subcutaneous (SC) injection 'as needed,' off-label, is becoming increasingly common in elderly patients, particularly to facilitate care. However, SC injection may be poorly tolerated by patients, difficult to administer, and may cause a feeling of mistreatment.
The aim of this clinical trial is to evaluate the efficacy and safety of an oral form of midazolam adapted for the elderly on the performance of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a \"n of one design\" study * Patients presenting opposition to at least two nursing care will be selected for the study. * Patients included in the study will be assigned a kit of 20 unit doses containing an oral gel of midazolam or placebo, according to a predefined sequence. Maximum 20 nursing care will be included in the study. * For each new opposition to treatment ≥ 3 on the Pittsburgh scale, the nurse will administer the next syringe from the kit in a double-blind manner, following the predefined order. Thirty to forty minutes after administration, the nurse will reassess the level of opposition and then attempt the same care again.
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: oral administration of midazolam or placeboThe nurse administers an oral dose of placebo to the patient |
| oral midazolam | Experimental | Drug: oral administration of midazolam or placeboThe nurse administers an oral dose of midazolam to the patient |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient hospitalized (for a minimum estimated duration of 21 days) in a geriatric department in Medical Care and Rehabilitation, Cognitive-Behavioral Unit, or housed in a Reinforced Housing Unit, in a Long-Term Care Unit, or in a Psycho-Geriatric Unit.
- Moderate to severe cognitive impairment, defined by a MMSE (Mini Mental State Examination) score \<15. If not feasible at inclusion, MMSE score \<15 less than 1 year old.
- Patient opposed to care, presenting at least two episodes of opposition to care (meals excluded) for which other non-medication alternatives have failed. These refusals of care are defined by a \"resistance to care\" score ≥3 on the Pittsburgh scale, over the last week. In practice, the resistance to care of patients is noted in the medical record following a weekly multidisciplinary decision.
- Essential nursing care (indispensable, mandatory, and prescribed) Bathing and changing made essential by obvious lack of hygiene after evaluation Bedtime installation (e.g., with the SECURIDRAP® device) technical care: blood tests, wound care, dressing changes, insertion of urinary or nasogastric tubes; administration of medication by parenteral route
- Person affiliated with social security or beneficiary of such a scheme
Key exclusion criteria (13 listed)
- Patient who has received midazolam treatment in the week before inclusion
- Patient with contraindications to midazolam:
- severe Myasthenia Severe respiratory failure requiring continuous oxygen therapy Severe liver failure: PT \<50% Severe sleep apnea syndrome not treated with a device Severe renal failure: Cockcroft \<20mL/min Severe heart failure in a state of decompensation History of alcoholism or drug addiction
- Known hypersensitivity to the active substance, benzodiazepines, or any of the excipients
- Patient being treated concurrently with:
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 |
|---|---|---|
| oral administration of midazolam or placeboIf the patient is opposed to a treatment (resistance to care ≥3 on the Pittsburgh scale), the nurse administers an oral dose of midazolam or placebo to the patient according to the random allocation. | Drug | oral midazolam, placebo |
Primary outcome
Evolution of resistance to care following oral administration of midazolam
Time frame: For each care: change of the care dimension of the Pittsburgh scale from the time of intention of care and 30 to 45 minutes after the study treatment intake.
The efficacy will be evaluated by a decrease of at least two points in the resistance to care dimension of the Pittsburgh scale. the care dimension scale has 4 points, 4 is the worst score, 0 is the better.
4 secondary outcomes
effectiveness of oral midazolam in terms of acceptance of care
Time frame: For each care : This scale is measured immédiately after the end of the care.
Evolution of agitation and refusal to care following oral administration of midazolam
Time frame: For each care: change from the time of intention of care and 30 to 45 minutes after the study treatment intake.
Number and description of Treatment-Related Adverse Events.
Time frame: From enrollment to the end of treatment at 4 months
Satisfaction of the caregiving staff.
Time frame: For each care: immediatly after the care.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Neurocognitive Disorders, run by University Hospital, Grenoble 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 13 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: looking for participants now, as of the sponsor's last update on 15 Dec 2025. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Virginie GARNIER, MD (0476767575 ext. +33, VGarnier@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of resistance to care following oral administration of midazolam (time frame: For each care: change of the care dimension of the Pittsburgh scale from the time of intention of care and 30 to 45 minutes after the study treatment intake.). 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 15 Dec 2025.