Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06375213
Status:
RECRUITING
Last Update Posted:
2024-04-22
First Post:
2024-04-16
Brief Title:
Investigating Neurocognitive Disorders Epidemiology
Sponsor:
King Chulalongkorn Memorial Hospital
Organization:
King Chulalongkorn Memorial Hospital
Study Overview
Official Title:
Investigating Neurocognitive Disorders Epidemiology
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INDE
Brief Summary:
This is a prospective cohort study with the main purpose of predicting progression neurocognitive disorders in Thai population The main predictor variables to be evaluated are plasma phosphorylated tau p-tau level and cognitive test scores which will be combined using statisticalcomputational modeling Additionally it seeks to evaluate biomarkers for diagnosing disease pathologies understand their correlation with clinical outcomes and explore the socioeconomic impact of neurocognitive disorders The study invites both participants for biospecimen collection structured interviews and cognitive examinations and schedules follow-up visits annually or biennially
Detailed Description:
The INDE study is a prospective cohort aimed at investigating the natural history and epidemiology of neurocognitive disorders in Thailand Its primary objective is to develop a predictive model that combines biomarkers eg plasma phosphorylated tau and cognitive performance to accurately predict cognitive decline Additional objectives include cross-sectional evaluation of various biomarkers for diagnosing disease pathologies identifying correlations between biomarkers and clinical outcomes understanding the impact of receiving a biological diagnosis describing the epidemiology of neurocognitive disorders including risk factors and social determinants of health SDH exploring the socioeconomic consequences of these disorders and establishing a biorepository for future research The study invites both healthy volunteers and patients referred from memory clinics to participate in a 4-hour visit during which various research procedures are conducted collection of biospecimens blood saliva sweat structured interviews covering symptoms comorbidities risk factors SDH and quality of life as well as a comprehensive cognitive examination Participants are scheduled for annual or biennial follow-up visits based on their cognitive status For those consenting to specific disclosures investigators provide some biomarker test results and offer post-test counseling based on available research literature Depending on current funding a subset of participants meeting additional criteria may also undergo evaluation using appropriate neuroimaging or cerebrospinal fluid CSF biomarkers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None