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

NCT ID: NCT06638710

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-08
• Study Completion Date: 2026-11-01

Brief 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.

Detailed Description

Neurodegenerative disorders may lead to behavioral disturbances that can result in oppositional reactions, making the performance of certain medical treatments complex.

Midazolam is used to reduce anxiety and agitation in elderly patients with moderate to severe neurocognitive disorders. It has the advantages of rapid action, short half-life, and good tolerability. A recent study shows that its use by subcutaneous (SC) injection 'as needed,' off-label, is becoming increasingly common in elderly patients, particularly to facilitate care. However, SC injection may be poorly tolerated by patients, difficult to administer, and may cause a feeling of mistreatment.

The aim of this clinical trial is to evaluate the efficacy and safety of an oral form of midazolam adapted for the elderly on the performance of care.

Conditions

Neurocognitive Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

placebo

The nurse administers an oral dose of placebo to the patient

Group Type: PLACEBO_COMPARATOR

oral administration of midazolam or placebo

Intervention Type: DRUG

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.

oral midazolam

The nurse administers an oral dose of midazolam to the patient

Group Type: EXPERIMENTAL

oral administration of midazolam or placebo

Intervention Type: DRUG

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.

Interventions

oral 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.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Geriatric department of Grenoble Alpes university hospital

Grenoble, Isere, France

Site Status: RECRUITING

Countries

France

Central Contacts

Virginie GARNIER, MD

Role: CONTACT

VGarnier@chu-grenoble.fr

0476767575 ext. +33

Facility Contacts

Virginie GARNIER, MD

Role: primary

VGarnier@chu-grenoble.fr

0476767575 ext. +33

Other Identifiers

38RC21.0436

Identifier Type: -

Identifier Source: org_study_id