Study of AI-Driven Imaging Markers for Early Dementia Diagnosis and Prognosis

Not Applicable

Recruiting

• Conditions: Mental and behavioural disorders

• Registration Number: KCT0008720
• Lead Sponsor: Konkuk University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 91

Inclusion Criteria

An individual who has completed all planned research visits by participating in one of the preceding studies (IRB No. 0114-01-300(CRIS Registration number KCT0003181), IRB No. 0114-01-180(CRIS Registration number KCT0008510)).
Age between 45 to 90 years old.
Individuals who have agreed to participate in the clinical trial and have voluntarily signed the written informed consent form.
Patients who meet one of the following diagnostic criteria:
: Those who meet the diagnostic criteria for clinically normal, subjective, or mild cognitive impairment (based on NIA-AA 2011).
: Those who meet the diagnostic criteria for clinically early Alzheimer's dementia (based on NIA-AA 2011).
Patients who scored 1.0 on the CDR (Clinical Dementia Rating) at baseline in previous studies.
Patients who scored 18 or higher on the MMSE and were mentally intact at baseline in previous studies.
Patients presenting with any contraindications to MRI examinations.
Patients presenting with any contraindications to MRI contrast medium:
: Gadovist (Renal failure) - Estimated Glomerular Filtration Rate (eGFR) <30 mL / min.

Exclusion Criteria

Those who did not participate in the previous studies (IRB No. 0114-01-300 (CRIS Registration number KCT0003181), IRB No. 0114-01-180 (CRIS Registration number KCT0008510)).
Individuals who have not completed all planned research visits in the preceding studies.
Patients presenting with any contraindication to MRI examination (e.g., history of brain surgery, presence of pacemakers, implanted metal devices, claustrophobia, or extensive tattoos).
Patients presenting with any contraindication to the MRI contrast medium, such as Gadovist, in cases of renal failure (estimated glomerular filtration rate, eGFR, less than 30 mL/min).

Study & Design

• Study Type: Observational Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The difference in Alzheimer's disease (AD) conversion rates between high-risk and low-risk groups of cognitive impairment patients, differentiated based on microvascular-targeted imaging.

Secondary Outcome Measures

Name	Time	Method
Changes in scores of cognitive function-related tests (such as MMSE, CDR, CDR-SB, SNSB-D, GDS, etc.) at follow-up from the baseline of the preceding study.; The changes in the volume of the whole brain and structures like the hippocampus, changes in microvascular-targeted structural imaging indicators, and changes in microvascular-target BBB permeability imaging indicators between the baseline of the preceding study and the follow-up examination period.