Health TrialsbyHealthPanel

Investigating Neurocognitive Disorders Epidemiology

ConditionsDementiaCognitive DeclineAlzheimer Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age35+
SponsorKing Chulalongkorn Memorial Hospital

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

  • Neurocognitive examination

    Other intervention

    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.

Treatment groups

990 Participants
are divided into 4 treatment groups
Group A: Cognitively healthy2 interventions
Group B: Mild cognitive impairment2 interventions
Group C: Late onset dementia2 interventions
Group D: Early onset dementia2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
At 2, 4, 6 and 8 years
2

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.

Time frame
At 2, 4, 6 and 8 years

Secondary outcomes

1

Changes in the Montreal Cognitive Assessment

Administered by a certified psychologist. Minimum value: 0 Maximum value: 30 Higher scores mean a better outcome.

Time frame
At 2, 4, 6 and 8 years
2

Changes in the Montreal Cognitive Assessment - Memory Index Score

Administered by a certified psychologist. Minimum value: 0 Maximum value: 15 Higher scores mean a better outcome.

Time frame
At 2, 4, 6 and 8 years
3

Changes in the Mini Mental State Examination

Administered by a certified psychologist. Minimum value: 0 Maximum value: 30 Higher scores mean a better outcome.

Time frame
At 2, 4, 6 and 8 years
4

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

Administered by a certified psychologist. Minimum value: 1 Maximum value: 19 Higher scores mean a better outcome.

Time frame
At 2, 4, 6 and 8 years

Other outcomes

1

Quality of life (WHOQOL-BREF)

Quality of life as measured by the Thai version of the WHOQOL-BREF questionnaire. The scales of 0-100 were subclassified for each QOL domain (ie. physical, psychological, social and environmental).

Time frame
within 14 days of baseline measurement
2

Quality of life (EQ-5D-5L)

Quality of life as measured by the Thai version of the EQ-5D-5L questionnaire. The raw scores were transformed to utility scores for Thai population as previously suggested (Pattanaphesaj J., 2018).

Time frame
within 14 days of baseline measurement
3

Number of modifiable risk factors

Count data of 0-12. Number of risk factors of the following 12 modifiable risk factors still present in a participant. 1. Untreated hearing impairment 2. High depression screening score 3. Active smoker 4. Social isolation 5. Untreated hypertension 6. Obesity 7. Untreated diabetes 8. Physical inactivity quantified by International physical inactivity questionnaire 9. Alcohol consumption over 21 units per week 10. Average sleep duration less than 6 hours per night 11. Low vegetable intake less than 2 servings per week 12. High red meat or processed meat intake over 5 serving per week

Time frame
Three months after disclosing the biomarker results.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

King Chulalongkorn Memorial Hospital

Lead sponsor

Health Systems Research Institute,Thailand

Collaborator

Source ClinicalTrials.gov
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