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Study on the Effectiveness and Safety of Oral Midazolam for Elderly Patients with Severe Neurocognitive Disorders and Care Resistance

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of the medication midazolam on patients with moderately severe to severe neurocognitive disorders, which often include symptoms like confusion and memory problems. These disorders can make it difficult for patients to cooperate with necessary medical care. The trial aims to evaluate how effective oral midazolam is in helping these patients receive care when they are resistant to it.

Participants in the study will receive midazolam in the form of a gel that is taken orally. The study will compare the effects of this treatment with a placebo to see if it helps reduce resistance to care. The trial will monitor changes in the patients' behavior and their acceptance of care, as well as any side effects that may occur. The study will also assess the overall experience of the caregivers providing the treatment.

The trial will take place over a period of time, during which patients will be observed for any improvements in their ability to accept care and any changes in their symptoms. The goal is to find out if midazolam can make it easier for patients with severe neurocognitive disorders to receive the medical attention they need.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient is required to provide informed consent, either personally or through a legal representative if unable to do so.

    The patient must be 60 years or older and hospitalized in a geriatric care unit for at least 21 days.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to confirm moderate to severe cognitive impairment, defined by a Mini Mental State Examination (MMSE) score of less than 15.

    The patient must have shown resistance to care, with at least two episodes of opposition to care, excluding meals, where non-drug alternatives have failed.

  3. Step 3

    Medication administration

    The patient receives midazolam orally. The specific dosage and frequency are determined by the healthcare provider based on individual needs.

    The medication is administered to help reduce resistance to care and manage agitation.

  4. Step 4

    Monitoring and evaluation

    The patient's response to the medication is monitored, focusing on a reduction in resistance to care by at least two points on the Pittsburgh scale.

    Secondary evaluations include measuring care acceptance, overall agitation, and vital signs such as oxygen saturation, respiratory rate, and heart rate.

  5. Step 5

    Feedback and conclusion

    At the end of the care session, a satisfaction questionnaire is completed to assess the perception of care quality.

    The trial is expected to conclude by October 2026, with ongoing assessments throughout the study period.

Who can join the trial?

6 criteria

  • Men and women aged 60 years and older.
  • Patient must be hospitalized for at least 21 days in a geriatric care unit, which could be a Medical and Rehabilitation Care unit, Cognitive-Behavioral Unit, Enhanced Care Unit, Long-Term Care Unit, or Psychogeriatric Unit.
  • Patient has moderate to severe cognitive impairment, shown by a **Mini Mental State Examination (MMSE)** score of less than 15. If the test cannot be done at the time of joining the study, a score of less than 15 from the past year is acceptable. The MMSE is a test that helps measure how well a person can think and remember.
  • Patient resists care, having at least two episodes of refusing care (not including meals) where other non-drug options have not worked. This refusal is measured by a **"resistance to care"** score of 3 or more on the Pittsburgh scale in the last week. The Pittsburgh scale is a tool used to assess how much a patient resists care.
  • Person must be affiliated with social security or benefit from such a system.
  • Informed consent must be given, written, and signed by the patient or their legal representative. This is necessary for adults who are under legal protection and cannot express their consent.

Who cannot join the trial?

8 criteria

  • Patients who have a known allergy or sensitivity to midazolam, which is a medication used to help with relaxation and sleep.
  • Patients who are currently taking medications that might interact negatively with midazolam.
  • Patients with severe liver problems, as this can affect how the body processes the medication.
  • Patients with a history of severe breathing problems, since midazolam can affect breathing.
  • Patients who are pregnant or breastfeeding, to avoid any potential risks to the baby.
  • Patients who have participated in another clinical trial recently, as this could affect the results of the study.
  • Patients with certain mental health conditions that might interfere with the study.
  • Patients who are unable to give informed consent, meaning they cannot fully understand and agree to participate in the study.
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Investigated drugs

Midazolam is a medication used in this trial to help manage care for patients with moderately severe to severe neurocognitive disorders who are resistant to receiving care. It is administered orally and is being evaluated for its effectiveness in facilitating the provision of necessary medical care to these patients.

What is already known about the treatment

Midazolam – Midazolam is administered orally and is currently being studied for its effectiveness and safety in elderly patients with moderate to severe neurocognitive disorders who resist care. It is primarily used to manage neurocognitive issues and agitation in older adults. The medication works by enhancing the effect of a neurotransmitter called GABA, which helps to calm the brain and nervous system. Midazolam belongs to the pharmacological class of benzodiazepines, which are commonly used for their sedative and anxiolytic properties.

Investigated diseases

Neurocognitive Disorders – These disorders involve a decline in cognitive function, affecting memory, attention, language, and problem-solving abilities. They are often seen in older adults and can range from mild to severe. As the condition progresses, individuals may experience increased confusion, difficulty with daily tasks, and changes in behavior. Agitation is a common symptom, characterized by restlessness, irritability, and resistance to care. This can lead to challenges in providing care and support to affected individuals. The progression of symptoms can vary widely among individuals, impacting their quality of life and interactions with caregivers.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-510277-33-00Protocol code38RC21.0436Estimated enrolment30 patientsSponsorCentre Hospitalier Universitaire Grenoble Alpes

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