Investigating Neurocognitive Disorders Epidemiology (INDE)

King Chulalongkorn Memorial Hospital

Status: Enrolling

Conditions: Alzheimer Disease; Cognitive Decline; Dementia

Treatments: Diagnostic Test: Plasma tau phosphorylated at Thr217; Other: Neurocognitive examination

Study type: Observational

Funder types: Other

Identifiers

NCT06375213

425/66

Details and patient eligibility

About

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.

Full 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.

Enrollment: 990 estimated patients

Sex: All

Ages: 35+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

990 participants in 4 patient groups

Cognitively healthy

Description:

This cohort includes participants with or without subjective complaints whose results of cognitive examination are normal. Participants will undergo clinical, epidemiological, and cognitive assessments, as well as biospecimen collection every two years, over an 8-year follow-up period.

Treatment:

Other: Neurocognitive examination

Diagnostic Test: Plasma tau phosphorylated at Thr217

Mild cognitive impairment

Description:

This cohort includes participants whose results of cognitive examination are abnormal but have not met the criteria for dementia. Participants will undergo annual clinical, epidemiological, and cognitive assessments, as well as biospecimen collection, for a duration of six years.

Treatment:

Other: Neurocognitive examination

Diagnostic Test: Plasma tau phosphorylated at Thr217

Late onset dementia

Description:

This cohort includes participants with dementia whose symptoms onset after the age of 65. Participants will undergo annual clinical, epidemiological, and cognitive assessments, as well as biospecimen collection, for a duration of two years.

Treatment:

Other: Neurocognitive examination

Diagnostic Test: Plasma tau phosphorylated at Thr217

Early onset dementia

Description:

This cohort includes participants with dementia whose symptoms onset before the age of 65. Participants will undergo annual clinical, epidemiological, and cognitive assessments, as well as biospecimen collection, for a duration of six years.

Treatment:

Other: Neurocognitive examination

Diagnostic Test: Plasma tau phosphorylated at Thr217