RecruitingPhase 2NCT06638710

Efficacy and Safety of Oral Midazolam Used for the Delivery of Care in Elderly Patient With Neurocognitive Disorders and Refusing Care.

Efficacy and Safety of Oral Midazolam for the Delivery of Care in Elderly Patient With Moderate to Severe Neurocognitive Disorders and Refusing Care

Sponsor

University Hospital, Grenoble

Enrollment

30 participants

Start Date

Jul 8, 2025

Study Type

INTERVENTIONAL

Conditions

Neurocognitive Disorders

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.

Eligibility

Min Age: 60 Years

Inclusion Criteria7

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)

Exclusion Criteria13

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
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.

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Interventions

DRUGoral administration of midazolam or placebo

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.