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

NCT06638710 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-12-15

No results posted yet for this study

Summary

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

  • Neurocognitive Disorders

Interventions

DRUG

oral administration of midazolam or placebo

If the patient is opposed to a treatment (resistance to care ≥3 on the Pittsburgh scale), the nurse administers an oral dose of midazolam or placebo to the patient according to the random allocation.

Sponsors & Collaborators

  • University Hospital, Grenoble

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-08
Primary Completion
2026-06-01
Completion
2026-11-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06638710 on ClinicalTrials.gov