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RECRUITING

NCT06375213

Investigating Neurocognitive Disorders Epidemiology

Sponsor: King Chulalongkorn Memorial Hospital

View on ClinicalTrials.gov

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 statistical/computational 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.

Key Details

Gender

All

Age Range

35 Years - Any

Study Type

OBSERVATIONAL

Enrollment

990

Start Date

2023-08-24

Completion Date

2035-08-24

Last Updated

2024-04-22

Healthy Volunteers

Yes

Conditions

Dementia Cognitive Decline Alzheimer Disease

Interventions

DIAGNOSTIC_TEST

Plasma tau phosphorylated at Thr217

Plasma concentration of tau protein phosphorylated at Thr217 as measured on the Meso Scale Discovery, single molecule array (Simoa) or the in-house mass spectrometry platform.

OTHER

Neurocognitive examination

Traditional (paper and pencil) neurocognitive/neuropsychiatric examination performed by certified psychologists. This includes: Mini Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), Clinical Dementia Rating (CDR), Wechsler Memory Scale - Fourth Edition (WMS-IV), Neuropsychiatric Inventory - Questionnaire (NPI-Q), Thai Geriatric Depression Scale (TGDS), General Anxiety Disorder - 7 (GAD-7), The Barthel activities of daily living (ADL) Index, Chula ADL Index.

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.

Locations (1)

King Chulalongkorn Memorial Hospital

Pathum Wan, Bangkok, Thailand