DementiaNCT06615167
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
A study testing ALZGUARD in people with Dementia and Major Neurocognitive Disorder, run by HAII corp.ltd at 3 sites in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Dementia, Major Neurocognitive Disorder
- What is being tested?
- ALZGUARD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 12 Sep 2024to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must be between 55 and 85 years old (both men and women).
- Participants must be able to understand and voluntarily agree to the purpose, content, and procedures of the clinical trial.
Who cannot join
- Participants with no literacy or illiteracy.
- Participants with an intellectual disability.
- Participants with presenting active psychiatric symptoms.
- Participants who have difficulty ALZGUARD application
- Participants who are unable to use a smartphone, unless they can use it with assistant.
- Participants with a history of suicidal ideation or suicidal complusion in the last 6 months.
- Other conditions as deemed inappropriate for study participant by the Principal Investigator(PI).
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites, 3 recruiting
- Recruiting
Kangwon National University Hospital
Chuncheon, Gangwon-do
YeShin Kim, yeshins@gmail.com
KungHee Bae, khjy2@naver.com
- Recruiting
Ewha Womans University Mokdong Medical Center
Seoul
GeonHa Kim, geonha@ewha.ac.kr
JiSook Lim, jsskin@naver.com
- Recruiting
Yongin Severance Hospital
Seoul
MinYoung Jeon, myc5198@gmail.com
JiSu Jeong, xodud1234@yuhs.ac
About this study
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
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.
Read the 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 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.
- Conditions
- Dementia, Major Neurocognitive Disorder
- Being tested
- ALZGUARD
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALZGUARDDevice
A digital therapeutic(DTx) application that uses artifical intelligence to analyze cognitive function and provide a diagnosis of dementia.
| Study group | Role | What they receive |
|---|---|---|
| ALZGUARD Intervention Group | Experimental | All participants wil use the ALZGAURD smartphone-based digital therapeutic(DTx) to assess cognitive function for detecting dementia. Receives: Device: ALZGUARD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 8 months
Secondary outcomes (2)
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.
Measured: up to 8 months
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.
Measured: up to 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start12 Sep 2024
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HAII corp.ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06615167
- Sponsor's protocol ID
- G00020
- Status last verified
- Sep 2024
- First submitted
- 20 Sep 2024
- Last updated
- 26 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06615167
- Acronym / sponsor ID
- G00020
- Conditions
- Dementia, Major Neurocognitive Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- HAII corp.ltdIndustry (pharma, biotech, devices)
- Study start
- 12 Sep 2024 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 26 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| ALZGUARD Intervention Group | Experimental | Device: ALZGUARDAll participants wil use the ALZGAURD smartphone-based digital therapeutic(DTx) to assess cognitive function for detecting dementia. |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants must be between 55 and 85 years old (both men and women).
- Participants must be able to understand and voluntarily agree to the purpose, content, and procedures of the clinical trial.
Key exclusion criteria (7 listed)
- Participants with no literacy or illiteracy.
- Participants with an intellectual disability.
- Participants with presenting active psychiatric symptoms.
- Participants who have difficulty ALZGUARD application
- Participants who are unable to use a smartphone, unless they can use it with assistant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALZGUARDA digital therapeutic(DTx) application that uses artifical intelligence to analyze cognitive function and provide a diagnosis of dementia. | Device | ALZGUARD Intervention Group |
Primary outcome
Area Under the Curve (AUC)
Time frame: up to 8 months
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.
2 secondary outcomes
Sensitivity
Time frame: up to 8 months
Specificity
Time frame: up to 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ALZGUARD in people with Dementia and Major Neurocognitive Disorder, run by HAII corp.ltd at 3 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rachel Lee (+82 10-7390-5023, rachel.lee@haii.io), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Curve (AUC) (time frame: up to 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2024.