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Efficacy and Safety of Oral Midazolam for Providing Care to Patients Who Refuse Treatment and Have Moderately Severe to Severe Neurocognitive Disorders
EU CTIS ID: 2023-510277-33-00
What this study is testing
Evaluation of the efficacy of oral midazolam in facilitating care delivery for elderly patients with moderate-to-severe neurocognitive disorders who resist care.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Men and women aged 60 and older
- A patient hospitalized (for an estimated minimum of 21 days) in the Geriatric Department of Medical and Rehabilitation Care (SMR), Cognitive-Behavioral Unit (UCC), or residing in an Enhanced Care Unit (UHR), a Long-Term Care Unit (USLD), or a Psychogeriatric Unit (5UPG)
- Moderate to severe cognitive impairment, defined by an MMSE (Mini-Mental State Examination) score <15. If this cannot be assessed at enrollment, an MMSE score <15 obtained within the past year
- A patient who resists treatment, having experienced at least two episodes of resistance to treatment (excluding meals) for which other non-pharmacological alternatives have failed. These instances of resistance to treatment are defined by a “resistance to treatment” score of ≥3 on the Pittsburgh Scale over the past week
- A person enrolled in Social Security or a similar program
- Informed consent, in writing and signed by the patient or their legal representative (for adults subject to legal guardianship and unable to give consent, pursuant to Article L 1121-8 of the Public Health Code)
You likely can't join if
- Patients who received midazolam (regardless of the route of administration) within one week prior to enrollment
- Patients also being treated with: CYP3A4 enzyme inhibitors or CYP3A4 enzyme inducers
- Weight < 50 kg and > 100 kg
- Gastrointestinal conditions that may limit or even prevent the absorption of midazolam (repeated vomiting, pancreatic insufficiency with steatorrhea, etc.; this list is not exhaustive: at the investigator’s discretion)
- Identification of anxiety, as defined by Item E of the NPI (Neuropsychiatric Inventory), based on a score of >2 for both frequency and severity, in accordance with HAS recommendations
- Identification of pain, defined by the Algoplus scale as a score of ≥ 2
See the full eligibility criteria
Who can join
- Men and women aged 60 and older
- A patient hospitalized (for an estimated minimum of 21 days) in the Geriatric Department of Medical and Rehabilitation Care (SMR), Cognitive-Behavioral Unit (UCC), or residing in an Enhanced Care Unit (UHR), a Long-Term Care Unit (USLD), or a Psychogeriatric Unit (5UPG)
- Moderate to severe cognitive impairment, defined by an MMSE (Mini-Mental State Examination) score <15. If this cannot be assessed at enrollment, an MMSE score <15 obtained within the past year
- A patient who resists treatment, having experienced at least two episodes of resistance to treatment (excluding meals) for which other non-pharmacological alternatives have failed. These instances of resistance to treatment are defined by a “resistance to treatment” score of ≥3 on the Pittsburgh Scale over the past week
- A person enrolled in Social Security or a similar program
- Informed consent, in writing and signed by the patient or their legal representative (for adults subject to legal guardianship and unable to give consent, pursuant to Article L 1121-8 of the Public Health Code)
What rules you out
- Patients who received midazolam (regardless of the route of administration) within one week prior to enrollment
- Patients also being treated with: CYP3A4 enzyme inhibitors or CYP3A4 enzyme inducers
- Weight < 50 kg and > 100 kg
- Gastrointestinal conditions that may limit or even prevent the absorption of midazolam (repeated vomiting, pancreatic insufficiency with steatorrhea, etc.; this list is not exhaustive: at the investigator’s discretion)
- Identification of anxiety, as defined by Item E of the NPI (Neuropsychiatric Inventory), based on a score of >2 for both frequency and severity, in accordance with HAS recommendations
- Identification of pain, defined by the Algoplus scale as a score of ≥ 2
- Identification of delusional symptoms, as defined by item E of the Cornell Scale: E > 0 (if score = a: at the physician’s discretion, this will be documented in the patient’s medical record)
- Subject currently excluded from another clinical trial
- A person deprived of liberty by an administrative or judicial decision; Article L 1121-6 of the Code of Public Security
- Patient with contraindications to midazolam: Myasthenia gravis
- Patient with contraindications to midazolam: Severe respiratory failure requiring continuous oxygen therapy
- Patients with contraindications to midazolam: Severe hepatic impairment: PT < 50%
- Patient with contraindications to midazolam: Severe, untreated sleep apnea syndrome (based on available medical data: AHI [Apnea-Hypopnea Index] >30/h if polysomnography was performed)
- Patients with contraindications to midazolam: Severe renal impairment: Cockcroft < 20 mL/min
- Patients with contraindications to midazolam: Severe heart failure in a state of decompensation (NYHA clinical severity class 4 and/or in a state of acute decompensation)
- Patient with contraindications to midazolam: History of alcoholism or substance abuse
- Known hypersensitivity to the active ingredient, benzodiazepines, or any of the excipients
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.