Investigating Neurocognitive Disorders Epidemiology

NCT ID: NCT06375213

Last Updated: 2024-04-22

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 990 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-08-24
• Study Completion Date: 2035-08-24

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 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.

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.

Conditions

Dementia; Cognitive Decline; Alzheimer Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cognitively healthy

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.

Plasma tau phosphorylated at Thr217

Intervention Type: DIAGNOSTIC_TEST

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.

Neurocognitive examination

Intervention Type: OTHER

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.

Mild cognitive impairment

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.

Plasma tau phosphorylated at Thr217

Intervention Type: DIAGNOSTIC_TEST

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.

Neurocognitive examination

Intervention Type: OTHER

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.

Late onset dementia

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.

Plasma tau phosphorylated at Thr217

Intervention Type: DIAGNOSTIC_TEST

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.

Neurocognitive examination

Intervention Type: OTHER

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.

Early onset dementia

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.

Plasma tau phosphorylated at Thr217

Intervention Type: DIAGNOSTIC_TEST

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.

Neurocognitive examination

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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.

Intervention Type: OTHER

Other Intervention Names

S-PLEX Human Tau (pT217) Kit; ALZpath pTau-217 CARe Advantage Kit

Eligibility Criteria

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.

• 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 Criteria

• Significant neurological or uncontrolled psychiatric illness.
• Significant unstable systemic condition or end-stage organ failure that affects study participation.

2. Mild Cognitive Impairment

• Significant neurological or uncontrolled psychiatric illness.
• Significant unstable systemic condition or end-stage organ failure that affects study participation.

3. Late Onset Dementia

• Significant neurological or uncontrolled psychiatric illness.
• Significant unstable systemic condition or end-stage organ failure that affects study participation.

4. Early Onset Dementia

• Significant neurological or uncontrolled psychiatric illness.
• Significant unstable systemic condition or end-stage organ failure that affects study participation.

• Minimum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Health Systems Research Institute,Thailand

OTHER_GOV

Sponsor Role: collaborator

King Chulalongkorn Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Poosanu Thanapornsangsuth

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thiravat Hemachudha, M.D.

Role: PRINCIPAL_INVESTIGATOR

Chulalongkorn University

Locations

King Chulalongkorn Memorial Hospital

Pathum Wan, Bangkok, Thailand

Site Status: RECRUITING

Countries

Thailand

Central Contacts

Poosanu Thanapornsangsuth, M.D.

Role: CONTACT

poosanu.t@chula.ac.th

+66 (0)2 2564000 ext. 3561

Thanakit Pongpitakmetha, M.D.

Role: CONTACT

thanakit.p@chula.ac.th

Facility Contacts

Adipa Chongsuksantikul, D.Eng.

Role: primary

adipar@gmail.com

+66 (0)84 1134443

References

Cho H, Choi JY, Hwang MS, Kim YJ, Lee HM, Lee HS, Lee JH, Ryu YH, Lee MS, Lyoo CH. In vivo cortical spreading pattern of tau and amyloid in the Alzheimer disease spectrum. Ann Neurol. 2016 Aug;80(2):247-58. doi: 10.1002/ana.24711. Epub 2016 Jul 8.

Reference Type: BACKGROUND

PMID: 27323247 (View on PubMed)

Morris JC. The Clinical Dementia Rating (CDR): current version and scoring rules. Neurology. 1993 Nov;43(11):2412-4. doi: 10.1212/wnl.43.11.2412-a. No abstract available.

Reference Type: BACKGROUND

PMID: 8232972 (View on PubMed)

Jack CR Jr, Bennett DA, Blennow K, Carrillo MC, Dunn B, Haeberlein SB, Holtzman DM, Jagust W, Jessen F, Karlawish J, Liu E, Molinuevo JL, Montine T, Phelps C, Rankin KP, Rowe CC, Scheltens P, Siemers E, Snyder HM, Sperling R; Contributors. NIA-AA Research Framework: Toward a biological definition of Alzheimer's disease. Alzheimers Dement. 2018 Apr;14(4):535-562. doi: 10.1016/j.jalz.2018.02.018.

Reference Type: BACKGROUND

PMID: 29653606 (View on PubMed)

American Psychiatric Association. Neurocognitive disorders. In Diagnostic and statistical manual of mental disorders (5th ed.). 2013.

Reference Type: BACKGROUND

Pattanaphesaj J, Thavorncharoensap M, Ramos-Goni JM, Tongsiri S, Ingsrisawang L, Teerawattananon Y. The EQ-5D-5L Valuation study in Thailand. Expert Rev Pharmacoecon Outcomes Res. 2018 Oct;18(5):551-558. doi: 10.1080/14737167.2018.1494574. Epub 2018 Jul 6.

Reference Type: BACKGROUND

PMID: 29958008 (View on PubMed)

Other Identifiers

425/66

Identifier Type: -

Identifier Source: org_study_id