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

NCT06638710 | Recruiting Phase 2

• 1 other identifier: 38RC21.0436
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurocognitive Disorders

Keywords

elderly; midazolam; care

Outcome Measures

Primary Outcomes (1)

• Evolution of resistance to care following oral administration of midazolam

  The efficacy will be evaluated by a decrease of at least two points in the resistance to care dimension of the Pittsburgh scale. the care dimension scale has 4 points, 4 is the worst score, 0 is the better.

  For each care: change of the care dimension of the Pittsburgh scale from the time of intention of care and 30 to 45 minutes after the study treatment intake.

Secondary Outcomes (4)

• effectiveness of oral midazolam in terms of acceptance of care

  For each care : This scale is measured immédiately after the end of the care.

• Evolution of agitation and refusal to care following oral administration of midazolam

  For each care: change from the time of intention of care and 30 to 45 minutes after the study treatment intake.

• Number and description of Treatment-Related Adverse Events.

  From enrollment to the end of treatment at 4 months

• Satisfaction of the caregiving staff.

  For each care: immediatly after the care.

Study Arms (2)

placebo

PLACEBO COMPARATOR

The nurse administers an oral dose of placebo to the patient

Drug: oral administration of midazolam or placebo

oral midazolam

EXPERIMENTAL

The nurse administers an oral dose of midazolam to the patient

Drug: oral administration of midazolam or placebo

Interventions

oral administration of midazolam or placebo 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; placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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)

You may not qualify if:

• 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 deprived of liberty by an administrative or judicial decision.

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

Geriatric department of Grenoble Alpes university hospital

Grenoble, Isere, 38043, France

RECRUITING

MeSH Terms

Conditions

Neurocognitive Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Virginie GARNIER, MD

CONTACT

0476767575; VGarnier@chu-grenoble.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinding will be carried out upstream by the pharmacy that will prepare the treatment kits. For each nursing treatment, the syringe will contain either midazolam or placebo according to randomization.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a \"n of one design\" study * Patients presenting opposition to at least two nursing care will be selected for the study. * Patients included in the study will be assigned a kit of 20 unit doses containing an oral gel of midazolam or placebo, according to a predefined sequence. Maximum 20 nursing care will be included in the study. * For each new opposition to treatment ≥ 3 on the Pittsburgh scale, the nurse will administer the next syringe from the kit in a double-blind manner, following the predefined order. Thirty to forty minutes after administration, the nurse will reassess the level of opposition and then attempt the same care again.

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: October 15, 2024
• Study Start: July 8, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)