RecruitingNCT06375213

Investigating Neurocognitive Disorders Epidemiology

Sponsor

King Chulalongkorn Memorial Hospital

Enrollment

990 participants

Start Date

Aug 24, 2023

Study Type

OBSERVATIONAL

Conditions

Dementia Cognitive Decline Alzheimer Disease

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.

Eligibility

Min Age: 35 Years

Inclusion Criteria14

Cognitively Healthy Individuals
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.
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.
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.
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 Criteria11

Significant neurological or uncontrolled psychiatric illness.
Significant unstable systemic condition or end-stage organ failure that affects study participation.
Mild Cognitive Impairment
Significant neurological or uncontrolled psychiatric illness.
Significant unstable systemic condition or end-stage organ failure that affects study participation.
Late Onset Dementia
Significant neurological or uncontrolled psychiatric illness.
Significant unstable systemic condition or end-stage organ failure that affects study participation.
Early Onset Dementia
Significant neurological or uncontrolled psychiatric illness.
Significant unstable systemic condition or end-stage organ failure that affects study participation.

Interventions

DIAGNOSTIC_TESTPlasma 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.

OTHERNeurocognitive 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.