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Investigating Neurocognitive Disorders Epidemiology

NCT06375213 · King Chulalongkorn Memorial Hospital
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

About this study
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.
Eligibility criteria
1. Cognitively Healthy Individuals INCLUSION CRITERIA * Demonstrate normal cognitive function within the expected range on objective cognitive tests. * Proficient in speaking and understanding Thai without the need for a translator to participate. EXCLUSION CRITERIA * Significant neurological or uncontrolled psychiatric illness. * Significant unstable systemic condition or end-stage organ failure that affects study participation. 2. Mild Cognitive Impairment INCLUSION CRITERIA * Display impaired/abnormal performance on objective cognitive tests. * Does not meet criteria for dementia per NIA-AA (or major neurocognitive disorder per DSM-5). * Proficient in speaking and understanding Thai without the need for a translator to participate. EXCLUSION CRITERIA * Significant neurological or uncontrolled psychiatric illness. * Significant unstable systemic condition or end-stage organ failure that affects study participation. 3. Late Onset Dementia INCLUSION CRITERIA * Display impaired/abnormal performance on objective cognitive tests. * Meets criteria for dementia per NIA-AA (or major neurocognitive disorder per DSM-5), including dementia due to Alzheimer's disease or other causes. * Begins to experience symptoms, identified by the physician as a part of dementia continuum, occurring after the age of 65. * Proficient in speaking and understanding Thai without the need for a translator to participate. EXCLUSION CRITERIA * Significant neurological or uncontrolled psychiatric illness. * Significant unstable systemic condition or end-stage organ failure that affects study participation. 4. Early Onset Dementia INCLUSION CRITERIA * Display impaired/abnormal performance on objective cognitive tests. * Meets criteria for dementia per NIA-AA (or major neurocognitive disorder per DSM-5), including dementia due to Alzheimer's disease or other causes. * Begins to experience symptoms, identified by the physician as a part of dementia continuum, occurring before the age of 65. * Proficient in speaking and understanding Thai without the need for a translator to participate. EXCLUSION CRITERIA * Significant neurological or uncontrolled psychiatric illness. * Significant unstable systemic condition or end-stage organ failure that affects study participation.
Study design
Enrollment target: 990 participants
Age groups: adult, older_adult
Timeline
Starts: 2023-08-24
Estimated completion: 2035-08-24
Last updated: 2024-04-22
Interventions
Diagnostic Test: Plasma tau phosphorylated at Thr217Other: Neurocognitive examination
Primary outcomes
  • Progression to dementia (At 2, 4, 6 and 8 years)
  • Changes in Sum of Boxes of the Clinical Dementia Rating Scale (At 2, 4, 6 and 8 years)
Sponsor
King Chulalongkorn Memorial Hospital · other
With: Health Systems Research Institute,Thailand
Contacts & investigators
ContactPoosanu Thanapornsangsuth, M.D. · contact · poosanu.t@chula.ac.th · +66 (0)2 2564000
ContactThanakit Pongpitakmetha, M.D. · contact · thanakit.p@chula.ac.th
InvestigatorThiravat Hemachudha, M.D. · principal_investigator, Chulalongkorn University
All locations (1)
King Chulalongkorn Memorial HospitalRecruiting
Pathum Wan, Bangkok, Thailand
Investigating Neurocognitive Disorders Epidemiology · TrialPath