Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06375213
Study type Observational [Patient Registry]
Source King Chulalongkorn Memorial Hospital
Contact Poosanu Thanapornsangsuth, M.D.
Phone +66 (0)2 2564000
Email poosanu.t@chula.ac.th
Status Recruiting
Phase
Start date August 24, 2023
Completion date August 24, 2035

See also
  Status Clinical Trial Phase
Completed NCT04044495 - Sleep, Rhythms and Risk of Alzheimer's Disease N/A
Completed NCT04079803 - PTI-125 for Mild-to-moderate Alzheimer's Disease Patients Phase 2
Terminated NCT03052712 - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies N/A
Recruiting NCT04520698 - Utilizing Palliative Leaders In Facilities to Transform Care for Alzheimer's Disease N/A
Active, not recruiting NCT04606420 - Can Lifestyle Changes Reverse Early-Stage Alzheimer's Disease N/A
Recruiting NCT05820919 - Enhancing Sleep Quality for Nursing Home Residents With Dementia - R33 Phase N/A
Terminated NCT03672474 - REGEnLIFE RGn530 - Feasibility Pilot N/A
Completed NCT03430648 - Is Tau Protein Linked to Mobility Function?
Recruiting NCT05288842 - Tanycytes in Alzheimer's Disease and Frontotemporal Dementia
Recruiting NCT04522739 - Spironolactone Safety in African Americans With Mild Cognitive Impairment and Early Alzheimer's Disease Phase 4
Recruiting NCT05557409 - A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation Phase 3
Recruiting NCT04949750 - Efficacy of Paper-based Cognitive Training in Vietnamese Patients With Early Alzheimer's Disease N/A
Completed NCT06194552 - A Multiple Dose Study of the Safety and Pharmacokinetics of NTRX-07 Phase 1
Completed NCT03239561 - Evaluation of Tau Protein in the Brain of Participants With Alzheimer's Disease Compared to Healthy Participants Early Phase 1
Completed NCT03184467 - Clinical Trial to Evaluate the Efficacy and Safety of GV1001 in Alzheimer Patients Phase 2
Active, not recruiting NCT03676881 - Longitudinal Validation of a Computerized Cognitive Battery (Cognigram) in the Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease
Terminated NCT03487380 - Taxonomic and Functional Composition of the Intestinal Microbiome: a Predictor of Rapid Cognitive Decline in Patients With Alzheimer's Disease N/A
Completed NCT05538455 - Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases N/A
Recruiting NCT05328115 - A Study on the Safety, Tolerability and Immunogenicity of ALZ-101 in Participants With Early Alzheimer's Disease Phase 1
Completed NCT05562583 - SAGE-LEAF: Reducing Burden in Alzheimer's Disease Caregivers Through Positive Emotion Regulation and Virtual Support N/A