King Chulalongkorn Memorial Hospital
Pathum Wan, Bangkok, 10330, Thailand
Location status: Recruiting
NCT Number: NCT06375213
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.
Interested in participating?
Request Info35 year and older
All sexes
Observational
Pathum Wan, Bangkok, 10330, Thailand
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Inclusion criteria
Exclusion criteria
Inclusion criteria
Exclusion criteria
Inclusion criteria
Exclusion criteria
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.
Other names: 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.
Time frame: At 2, 4, 6 and 8 years
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
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
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
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
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
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
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
Administered by a certified psychologist. Minimum value: 1 Maximum value: 19 Higher scores mean a better outcome.
Time frame: within 6 months of baseline measurement
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
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
Amyloid PET uptake tracer uptake quantified in Centiloids.
Time frame: within 6 months of baseline measurement
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: At 2, 4, 6 and 8 years
All of the following:
Time frame: within 14 days of baseline measurement
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 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: Three months after disclosing the biomarker results.
Count data of 0-12. Number of risk factors of the following 12 modifiable risk factors still present in a participant.
Contact information is provided by the study sponsor or research team.
Poosanu Thanapornsangsuth, M.D.
CONTACT
+66 (0)2 2564000 ext. 3561
Thanakit Pongpitakmetha, M.D.
CONTACT
King Chulalongkorn Memorial Hospital
Other
Acronym: INDE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06733714
Alzheimer Disease, Arterial Occlusive Diseases
Rio de Janeiro, Brazil
View Trial DetailsNCT03657745
Alzheimer Disease, Brain Diseases
Miami, Florida, United States
View Trial DetailsNCT05607732
Alzheimer Disease, Brain Diseases
Chicago, Illinois, United States
View Trial DetailsNCT07016178
Alzheimer Disease, Alzheimer's Disease (Incl Subtypes)
Indianapolis, Indiana, United States
View Trial Details