Actively Recruiting
Efficacy and Safety of Oral Midazolam Used for the Delivery of Care in Elderly Patient With Neurocognitive Disorders and Refusing Care.
Led by University Hospital, Grenoble · Updated on 2025-12-15
30
Participants Needed
1
Research Sites
68 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Efficacy and Safety of Oral Midazolam Used for the Delivery of Care in Elderly Patient With Neurocognitive Disorders and Refusing Care.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient hospitalized at least 21 days in geriatric, cognitive-behavioral, reinforced housing, long-term care, or psycho-geriatric units
- Moderate to severe cognitive impairment with MMSE score less than 15 or equivalent within 1 year
- Patient shows resistance to care with at least two episodes of opposition (excluding meals) and a resistance score of 3 or higher on the Pittsburgh scale in the last week
- Resistance to care documented by weekly multidisciplinary decision
- Care includes essential nursing, technical care, and medication administration by injection
- Person affiliated with social security or equivalent
- Informed, written, signed consent by patient or legal representative
You will not qualify if you...
- Received midazolam treatment within 1 week before inclusion
- Severe myasthenia
- Severe respiratory failure requiring continuous oxygen therapy
- Severe liver failure with PT less than 50%
- Untreated severe sleep apnea syndrome
- Severe renal failure with Cockcroft less than 20 mL/min
- Severe heart failure in decompensation
- History of alcoholism or drug addiction
- Known hypersensitivity to midazolam, benzodiazepines, or excipients
- Concurrent treatment with CYP3A4 enzyme inhibitors or inducers
- Weight below 50 kg or above 100 kg
- Gastrointestinal conditions limiting midazolam absorption
- Anxiety score above 2 on item E of the neuropsychiatric inventory
- Pain score 2 or higher on the Algoplus scale
- Ideational disorders with score above 0 on item E of the Cornell scale
- Participation in another clinical trial exclusion period
- Subject deprived of liberty by judicial or administrative decision
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Geriatric department of Grenoble Alpes university hospital
Grenoble, Isere, France, 38043
Actively Recruiting
Research Team
V
Virginie GARNIER, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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