Investigating Neurocognitive Disorders Epidemiology

NCT06375213 | Recruiting

• 1 other identifier: 425/66
• Study Type: observational
• Target: 990
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia; Cognitive Decline; Alzheimer Disease

Outcome Measures

Primary Outcomes (2)

• Progression to dementia

  Fulfilling the criteria for dementia according to the National Institute on Aging and the Alzheimer's Association (NIA-AA) 2018 criteria or major neurocognitive disorder (according to DSM-5) as evaluated by neurologist with special interests in neurocognitive disorders. If such designation is not available, reaching a global CDR score of 1 will be used as a substitute. This outcome only applies to cognitively healthy and mild cognitive impairment cohort.

  At 2, 4, 6 and 8 years

• Changes in Sum of Boxes of the Clinical Dementia Rating Scale

  Administered by a certified psychologist in accordance with Morris, J.C. (1993). Minimum value: 0 Maximum value: 18 Higher scores mean a worse outcome.

  At 2, 4, 6 and 8 years

Secondary Outcomes (11)

• Changes in the Montreal Cognitive Assessment

  At 2, 4, 6 and 8 years

• Changes in the Montreal Cognitive Assessment - Memory Index Score

  At 2, 4, 6 and 8 years

• Changes in the Mini Mental State Examination

  At 2, 4, 6 and 8 years

• Changes in the Wechsler Memory Scale - Fourth Edition (WMS-IV) Visual Reproduction Scaled Score

  At 2, 4, 6 and 8 years

• Changes in the Wechsler Memory Scale - Fourth Edition (WMS-IV) Logical Memory Scaled Score

  At 2, 4, 6 and 8 years

Other Outcomes (3)

• Quality of life (WHOQOL-BREF)

  within 14 days of baseline measurement

• Quality of life (EQ-5D-5L)

  within 14 days of baseline measurement

• Number of modifiable risk factors

  Three months after disclosing the biomarker results.

Study Arms (4)

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.

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

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.

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

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.

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

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.

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

Interventions

Plasma tau phosphorylated at Thr217 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.

Also known as: S-PLEX Human Tau (pT217) Kit, ALZpath pTau-217 CARe Advantage Kit

Cognitively healthy; Early onset dementia; Late onset dementia; Mild cognitive impairment

Neurocognitive examination 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.

Cognitively healthy; Early onset dementia; Late onset dementia; Mild cognitive impairment

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The target population of this study comprises individuals with a risk of cognitive decline in Thailand categorized by their cognitive status.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• King Chulalongkorn Memorial Hospital: lead
• Health Systems Research Institute,Thailand: collaborator

Study Sites (1)

King Chulalongkorn Memorial Hospital

Pathum Wan, Bangkok, 10330, Thailand

RECRUITING

Related Publications (5)

• 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.

  PMID: 27323247 BACKGROUND

• 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.

  PMID: 8232972 BACKGROUND

• 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.

  PMID: 29653606 BACKGROUND

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

  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.

  PMID: 29958008 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Ethylenediaminetetraacetic acid (EDTA) plasma and buffy coat, EDTA whole blood, serum, saliva

MeSH Terms

Conditions

Dementia; Cognitive Dysfunction; Alzheimer Disease

Interventions

Genes, fms

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Tauopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Proto-Oncogenes; Oncogenes; Genes, Neoplasm; Genes; Genome Components; Genome; Genetic Structures; Genetic Phenomena

Study Officials

• Thiravat Hemachudha, M.D.

  Chulalongkorn University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Poosanu Thanapornsangsuth, M.D.

CONTACT

+66 (0)2 2564000; poosanu.t@chula.ac.th

Thanakit Pongpitakmetha, M.D.

CONTACT

thanakit.p@chula.ac.th

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 8 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 19, 2024
• Study Start: August 24, 2023
• Primary Completion (Estimated): August 24, 2035
• Study Completion (Estimated): August 24, 2035
• Last Updated: April 22, 2024

Record last verified: 2024-04

Locations

TH (1)