MIDAZOLAM for Neurocognitive disorders|Agitation in older adults

Inclusion criteria

• {"criterion_text":"- Men and women aged 60 and older\n- 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)\n- 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\n- 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\n- A person enrolled in Social Security or a similar program\n- 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)"}

Exclusion criteria

• {"criterion_text":"- Patients who received midazolam (regardless of the route of administration) within one week prior to enrollment\n- Patients also being treated with: CYP3A4 enzyme inhibitors or CYP3A4 enzyme inducers\n- Weight < 50 kg and > 100 kg\n- 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)\n- 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\n- Identification of pain, defined by the Algoplus scale as a score of ≥ 2\n- 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)\n- Subject currently excluded from another clinical trial\n- A person deprived of liberty by an administrative or judicial decision; Article L 1121-6 of the Code of Public Security\n- Patient with contraindications to midazolam: Myasthenia gravis\n- Patient with contraindications to midazolam: Severe respiratory failure requiring continuous oxygen therapy\n- Patients with contraindications to midazolam: Severe hepatic impairment: PT < 50%\n- 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)\n- Patients with contraindications to midazolam: Severe renal impairment: Cockcroft < 20 mL/min\n- 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)\n- Patient with contraindications to midazolam: History of alcoholism or substance abuse\n- Known hypersensitivity to the active ingredient, benzodiazepines, or any of the excipients"}

Primary endpoints

• {"endpoint_text":"- A decrease of at least two points on the “resistance to treatment” subscale of the Pittsburgh Scale","definition_or_measurement_approach":"Change in score on the 'resistance to treatment' subscale of the Pittsburgh Scale; endpoint defined as a decrease of at least two points on that subscale."}

Secondary endpoints

• {"endpoint_text":"- Care Acceptance Scale according to Rignell et al. (2007), measured at the end of care\n- Overall score on the Pittsburgh Agitation Scale, measured 30 to 45 minutes after administration of oral midazolam gel. This scale assesses four dimensions, rated on a scale of 0 to 4. Subscore for resistance to care\n- Measurement of oxygen saturation, respiratory rate, and heart rate, and recording of serious and non-serious adverse events occurring following administration of midazolam gel\n- Satisfaction survey on healthcare providers’ perception of patient well-being (unvalidated questionnaire developed specifically for the clinical trial), completed at the end of care","definition_or_measurement_approach":"Care Acceptance Scale: measured at end of care per Rignell et al. (2007). Pittsburgh Agitation Scale: overall score measured 30–45 minutes post-administration; includes subscores (resistance to care). Safety: measurement of oxygen saturation, respiratory rate, heart rate, and collection of serious and non-serious adverse events after administration. Satisfaction: unvalidated caregiver questionnaire completed at end of care."}

France

Earliest CTIS Part Ii Submission Date

29-04-2024

Latest Decision Or Authorization Date

17-04-2026

Processing Time Days

718

Number Of Sites

1

Number Of Participants

30

Primary sponsor

Full Name

Centre Hospitalier Universitaire Grenoble Alpes

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France