Oral midazolam to help deliver care for older adults with neurocognitive disorders who refuse care
Efficacy and Safety of Oral Midazolam for the Delivery of Care in Elderly Patient With Moderate to Severe Neurocognitive Disorders and Refusing Care
This study will try a short-acting oral midazolam to help nurses and caregivers give essential care to older adults with moderate to severe neurocognitive disorders who resist or refuse care.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | University Hospital, Grenoble Academic / other |
| Locations | 1 site (Grenoble, Isere) |
| Trial ID | NCT06638710 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are hospitalized older adults with moderate to severe cognitive impairment (MMSE <15) who have had at least two documented episodes of refusing essential care despite non‑pharmacologic measures.
Not a fit: Patients with mild cognitive impairment, those who accept care without resistance, or those with contraindications to benzodiazepines are unlikely to benefit.
Why it matters
Potential benefit: If successful, the oral medication could make essential nursing care easier to perform while reducing patient distress and the need for injections or coercive measures.
How similar studies have performed: Some off-label use of subcutaneous midazolam has been reported to ease agitation and facilitate care, but oral formulations specifically tested for this purpose in this population are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Grenoble, Isere
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.