RecruitingPHASE2INTERVENTIONAL

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

This study is exploring if a liquid form of midazolam, given by mouth, can safely and effectively help older patients who have memory problems (neurocognitive disorders) and often refuse needed care. Sometimes, older patients with these conditions can become distressed and resist important treatments like baths or wound care. Currently, a similar medicine is sometimes given by injection, but this can be uncomfortable. This study aims to see if an oral, easier-to-take version works well. Researchers will compare midazolam to a placebo (a dummy medicine) to understand if it reduces anxiety and makes essential care easier to provide, improving comfort for these patients. It's a Phase 2 trial, meaning it's still in the earlier stages of research.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

University Hospital, Grenoble

Enrolment target

Start

08 Jul 2025

Estimated completion

01 Nov 2026

Neurocognitive Disorders

What is this study about?

When people get older and develop conditions that affect their memory and thinking, like dementia (often called neurocognitive disorders), they can sometimes become upset or refuse to have necessary medical care. This can make simple things, like having a bath, changing dressings, or taking medicines, very difficult for both the patient and their carers.

At the moment, a medicine called midazolam is sometimes used by injection to help calm patients and make care easier. While it works quickly, injections can be uncomfortable, and some patients might find them distressing or feel like they are being mistreated. This can add stress to an already difficult situation.

This study is trying to find a better way. It's looking at whether giving midazolam as a liquid by mouth will be just as effective and much more comfortable for these patients. The main goal is to see if this oral liquid can help reduce anxiety and resistance for older patients with moderate to severe memory problems, making essential care tasks smoother and more peaceful for everyone involved. By doing this, the researchers hope to improve the overall comfort and quality of care for these vulnerable patients.

Key takeaways

A study for older patients (60+) with memory problems.
Aims to make essential care easier by reducing anxiety and resistance.
Tests an oral liquid form of midazolam versus a dummy medicine.
Hopes to offer a more comfortable way to deliver care compared to injections.
Your health and comfort will be closely monitored throughout the study.

Who may be eligible?

To join this study, you would need to be an older person, aged 60 or over, who is currently staying in a special care unit for older people, like a geriatrics ward or a long-term care unit. You would also need to have moderate to severe memory and thinking difficulties (neurocognitive disorders).

A key part of joining is that you must have shown resistance to care at least twice in the last week, such as refusing a bath or having a dressing changed, and other calming methods without medicine haven't helped. We wouldn't count refusing meals in this part. You also need to be a UK resident and either you or your legal representative must agree in writing to take part.

You wouldn't be able to join if you've already had midazolam in the week before the study starts, or if you have certain serious health conditions like severe breathing or liver problems, or if you're allergic to midazolam or similar medicines.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you aged 60 or older?
Are you currently staying in a care unit for older people (e.g., geriatric ward, long-term care)?
Do you have moderate to severe memory and thinking difficulties (neurocognitive disorder)?
Have you recently shown resistance to receiving personal care or medical treatments (at least twice in the last week, not including meals), and other methods haven't helped?
Are you a UK resident, and are you or your legal representative able to give written consent?

Answer every question to see your result.

What does participation involve?

If you join this study, you would be assigned to either receive the oral midazolam or a dummy medicine (placebo). You wouldn't know which one you are getting. The study team would give you the study medicine when you are showing resistance to essential care (like bathing or medical procedures). They would then observe how well the medicine works to help you accept care and if there are any side effects. You would also have regular checks on your general health and how well your memory and thinking are doing. The total duration of your participation would depend on how long you remain in the care facility, but the actual study medication would only be given as needed to help with care.

Potential risks and benefits

The potential benefits of taking part could include making necessary care tasks less stressful and more comfortable for you, by reducing anxiety and resistance. This could improve your overall well-being. However, like all medicines, midazolam can have side effects, such as drowsiness, dizziness, or changes in breathing. The study team will carefully monitor you for any such effects. There is also the possibility that the medicine may not work for you. It's important to remember that you, or your legal representative, have the right to withdraw from the study at any time, for any reason, without it affecting your usual care.

Locations (1)

Geriatric department of Grenoble Alpes university hospital
Verified postcode
Grenoble, France· Recruiting

Common questions

What is midazolam?

Midazolam is a medicine that helps to calm people down, reduce anxiety, and can make you feel sleepy. It's used in this study to help make necessary care easier for people who are distressed or refusing treatment.

What are neurocognitive disorders?

These are conditions that affect a person's thinking, memory, and ability to make decisions, such as Alzheimer's disease or other forms of dementia.

What is a placebo?

A placebo is a 'dummy' medicine that looks just like the real medicine but contains no active ingredients. It's used in studies to compare the effects of the real medicine.

Why is oral midazolam being tested?

It's being tested to see if it's a more comfortable and effective way to give the medicine compared to injections, particularly for older people who might find injections distressing.

Will I know if I'm getting the real medicine or the placebo?

No, in this type of study (called a 'blinded' study), neither you nor the doctors treating you will know whether you are receiving midazolam or the placebo. This helps ensure the results are accurate.

How to find out more

Virginie GARNIER, MD

vgarnier@chu-grenoble.fr 0476767575 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.