Can a simple syrup ease care for dementia patients who resist?
NCT ID NCT06638710
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests if a liquid medicine called midazolam can help elderly patients with moderate to severe memory problems who refuse care. About 30 hospitalized patients will receive the medicine before care to see if it reduces their resistance. The goal is to make necessary care easier and less stressful for both patients and caregivers.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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60 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Geriatric department of Grenoble Alpes university hospital
RECRUITINGGrenoble, Isere, 38043, France
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Other studies related to the condition(s) this trial covers.
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