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Tests treatment safety and results for Neurocognitive Disorders
Official title Efficacy and Safety of Oral Midazolam Used for the Delivery of Care in Elderly Patient With Neurocognitive Disorders and Refusing Care.
ClinicalTrials.gov ID: NCT06638710
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older
You may be able to join if
- Patient hospitalized (for a minimum estimated duration of 21 days) in a geriatric department in Medical Care and Rehabilitation, Cognitive-Behavioral...
- Moderate to severe cognitive impairment, defined by a MMSE (Mini Mental State Examination) score \<15. If not feasible at inclusion, MMSE score \<15...
- Patient opposed to care, presenting at least two episodes of opposition to care (meals excluded) for which other non-medication alternatives have...
- 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...
You likely can't join if
- 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...
- Known hypersensitivity to the active substance, benzodiazepines, or any of the excipients
- Patient being treated concurrently with: CYP3A4 enzyme inhibitors CYP3A4 enzyme inducers
- Weight \ 100 kg
- Gastrointestinal pathology that may limit or prevent the absorption of midazolam
See the full eligibility 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...
- 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\"...
- 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)
- 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...
- Known hypersensitivity to the active substance, benzodiazepines, or any of the excipients
- Patient being treated concurrently with: CYP3A4 enzyme inhibitors CYP3A4 enzyme inducers
- Weight \ 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.
The study team makes the final eligibility decision.
Where it's taking place
- Grenoble, Isere, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Grenoble, Isere, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.