An observational study in Dementia, Cognitive Decline and Alzheimer Disease, sponsored by King Chulalongkorn Memorial Hospital. Recruiting at 1 site in Thailand. Open to participants aged 35 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-22.
Sponsored by King Chulalongkorn Memorial Hospital · Observational
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.
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.
3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.
This study's planned enrollment of 990 is above the median of 200 across 814 observational studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →King Chulalongkorn Memorial Hospital is the lead sponsor of 43 studies on the registry; 11 are open to participants now.
Compared within Alzheimer Disease, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Dementia. The counts are of registry records indexed under each term, refreshed daily. How we classify →
The target population of this study comprises individuals with a risk of cognitive decline in Thailand categorized by their cognitive status.
Cognitively Healthy Individuals
INCLUSION CRITERIA
EXCLUSION CRITERIA
Mild Cognitive Impairment
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Late Onset Dementia
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
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
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.
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
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
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
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
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
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
Changes in the Wechsler Memory Scale - Fourth Edition (WMS-IV) Logical Memory 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
Changes in the Wechsler Memory Scale - Fourth Edition (WMS-IV) Verbal Paired Associates 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
Biological diagnosis of Alzheimer's disease
Receiving the diagnosis of Alzheimer's disease based on the abnormality of any pathology-specific biomarkers that fulfills the current NIA-AA criteria. These biomarkers include, but not limited to, amyloid positron emission tomography (PET) (eg. \[18 F\]-Florbetaben PET), tau-PET (eg. \[18F\]PI-2620 PET), or CSF levels of core Alzheimer's disease biomarkers.
Time frame: within 6 months of baseline measurement
Biological staging of Alzheimer's disease
Staging of Alzheimer's disease based on the abnormality of pathology-specific biomarkers according to the current NIA-AA criteria.
Time frame: within 6 months of baseline measurement
Quantitative amyloid PET uptake.
Amyloid PET uptake tracer uptake quantified in Centiloids.
Time frame: within 6 months of baseline measurement
Quantitative tau PET uptake in various cortical regions.
Cortical tau-PET uptake measured using mean standardized uptake value ratios of referenced against inferior cerebellar cortex. The pre-specified regions of interest are analogous with Braak staging (as suggested by Cho, H. (2016).): Stage I-II, entorhinal cortex; Stage III, parahippocampal and fusiform cortices, and amygdala; Stage IV, inferior and middle temporal cortices; Stage V, inferior parietal, posterior cingulate, lingual, orbitofrontal, insular, supramarginal, lateral occipital, superior temporal, precuneus, superior parietal, superior, middle, and inferior frontal, and anterior cingulate cortices; Stage VI, medial occipital, precentral, paracentral, and postcentral cortices.
Time frame: within 6 months of baseline measurement
Future diagnosis of Alzheimer's disease dementia.
All of the following: 1. Fulfilling the criteria for dementia (NIA-AA 2018) or major neurocognitive disorder (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. 2. Receiving the diagnosis of Alzheimer's disease based on the abnormality of any pathology-specific biomarkers that fulfills the current NIA-AA criteria. These biomarkers include, but not limited to, amyloid-PET (eg. \[18 F\]-Florbetaben PET), tau-PET (eg. \[18F\]PI-2620 PET), or CSF levels of core Alzheimer's disease biomarkers. 3. Conclusion made by a neurologist with special interests in neurocognitive disorders that dementia is predominately due to Alzheimer's disease.
Time frame: At 2, 4, 6 and 8 years
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
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
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.
Plan to share: Undecided
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King Chulalongkorn Memorial Hospital