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The goal of this clinical trial is to evalute the efficacy of ALZGUARD, a smartphone-based digital therapeutic(DTx), in comparison to diagnosis by medical doctors, as weel as to assess the safety of the application.
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 Curve(AUC), 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALZGUARD Intervention Group | Experimental | All participants wil use the ALZGAURD smartphone-based digital therapeutic(DTx) to assess cognitive function for detecting dementia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALZGUARD | Device | A digital therapeutic(DTx) application that uses artifical intelligence to analyze cognitive function and provide a diagnosis of dementia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve (AUC) | The primary outcome will be the Area Under the Curve (AUC), which will assess the diagnostic accuracy of ALZGUARD by comparing its results with the clinical diagnosis made by neurologists. AUC will be calculated to determine the performance of ALZGUARD in detecting dementia. | up to 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity | The one of the secondary outcome will measure the sensitivity of ALZGUARD in detecting dementia. Sensitivity refers to the proportion of true positive cases accurately identified by ALZGUARD, compared to clinical diagnosis made by neurologists. This measure will assess the ability of ALZGUARD to correctly identiry patients who have dementia. | up to 8 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rachel Lee | Contact | +82 10-7390-5023 | rachel.lee@haii.io |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kangwon National University Hospital | Recruiting | Chuncheon | Gangwon-do | South Korea |
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This is a single-arm, interventional clinical trial designed to evlauate the efficacy and safety of ALZGAURD, a smartphone-based digital therapeutic, in detecting dementia.
Study type: interentional (clinical trial) Masking: Single-blind (Outcomes assessor) Intervention description: The ALZGUARD application will be used by participants to assess cognitive function. Results will be compared to clinical diagnoses made by neurologists.
Primary Outcome: the accuracy of the ALZGUARD diagnosis, measured by Area Under the Curve.
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In this study, there will be two data analysts involved. Analyst 1 will be responsible for analyzing the results generated by the ALZGUARD application, which are based on the ALZGUARD AI model. This analyst will assess whether each subject has dementia and the likelihood or probability of the diagnosis. Analyst 1 will be blinded to any clinical assessments or dianoses made by the neurologists.
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| Specificity | Specificity refers to the proportion of true negative cases accurately identified by ALZGUARD, compared to the clinical diagnosis made by neurologists. This outcome will assess the ability of ALZGUARD to correctly identify patient who do not have dementia. | up to 8 months |
| Ewha Womans University Mokdong Medical Center | Recruiting | Seoul | South Korea |
|
| Yongin Severance Hospital | Recruiting | Seoul | South Korea |
|
| ID | Term |
|---|---|
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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