Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06638710
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-10
Brief Title:
Efficacy and Safety of Oral Midazolam Used for the Delivery of Care in Elderly Patient with Neurocognitive Disorders and Refusing Care
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy and Safety of Oral Midazolam for the Delivery of Care in Elderly Patient with Moderate to Severe Neurocognitive Disorders and Refusing Care
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MIRAGE
Brief 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
Detailed Description:
Neurodegenerative disorders may lead to behavioral disturbances that can result in oppositional reactions making the performance of certain medical treatments complex
Midazolam is used to reduce anxiety and agitation in elderly patients with moderate to severe neurocognitive disorders It has the advantages of rapid action short half-life and good tolerability A recent study shows that its use by subcutaneous SC injection as needed off-label is becoming increasingly common in elderly patients particularly to facilitate care However SC injection may be poorly tolerated by patients difficult to administer and may cause a feeling of mistreatment
The aim of this clinical trial is to evaluate the efficacy and safety of an oral form of midazolam adapted for the elderly on the performance of care
Midazolam is used to reduce anxiety and agitation in elderly patients with moderate to severe neurocognitive disorders It has the advantages of rapid action short half-life and good tolerability A recent study shows that its use by subcutaneous SC injection as needed off-label is becoming increasingly common in elderly patients particularly to facilitate care However SC injection may be poorly tolerated by patients difficult to administer and may cause a feeling of mistreatment
The aim of this clinical trial is to evaluate the efficacy and safety of an oral form of midazolam adapted for the elderly on the performance of care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None