Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06615167
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-20
Brief Title:
Confirmatory Clinical Trial for Verifying the Efficacy and Safety of ALZGUARD as a Digital Dementia Diagnostic Aid-Tool for the Diagnosis of the Major Neurocognitive Disorders
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Single-blind Data Analyst 1 Single-arm Design Prospective Multi-center Confirmatory Clinical Trial for Verifying the Efficacy and Safety of ALZGUARD as a Digital Dementia Diagnostic Aid-Tool for the Diagnosis of the Major Neurocognitive Disorders According to DSM-5
Status:
RECRUITING
Status Verified Date:
2024-09
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:
None
Brief Summary:
The goal of this clinical trial is to evalute the efficacy of ALZGUARD a smartphone-based digital therapeuticDTx in comparison to diagnosis by medical doctors as weel as to assess the safety of the application
Detailed Description:
The study will be conducted across multiple sites enrolling participants aged 55 to 85 years olds
The primary objective of the study is to compare the diagnositic accuracy of ALZGAURD against traditional diagnostic evaluactions conducted by medical professionals The primary endpoint for efficacy will be the Area Under the CurveAUC which will measure the diagnostic performance of the application This statistical metric will help determine how well ALZGUARD can identify dementia compared to standard diagnostic methods
The primary objective of the study is to compare the diagnositic accuracy of ALZGAURD against traditional diagnostic evaluactions conducted by medical professionals The primary endpoint for efficacy will be the Area Under the CurveAUC which will measure the diagnostic performance of the application This statistical metric will help determine how well ALZGUARD can identify dementia compared to standard diagnostic methods
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