Oral midazolam to help deliver care for older adults with neurocognitive disorders who refuse care

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2, single-center, randomized, placebo-controlled trial tests an oral midazolam formulation adapted for older adults against placebo to facilitate essential nursing care in hospitalized patients with moderate-to-severe neurocognitive disorders who refuse care. Eligible participants are hospitalized in geriatric or long-term care units with MMSE <15 and documented episodes of care refusal despite non-drug approaches. The main outcomes focus on whether oral midazolam improves the ability to perform prescribed essential care measures and on safety/tolerability of the medication. The study is conducted at the geriatric department of Grenoble Alpes University Hospital.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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.

Where it's running

• Geriatric department of Grenoble Alpes university hospital
  Grenoble, Isere, France Recruiting

Study contacts

• Study coordinator: Virginie GARNIER, MD
• Email: VGarnier@chu-grenoble.fr
• Phone: 0476767575

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.