Investigating Neurocognitive Disorders Epidemiology
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Dementia
- Sponsor
- King Chulalongkorn Memorial Hospital
- Enrollment
- 990
- Locations
- 1
- Primary Endpoint
- Changes in Sum of Boxes of the Clinical Dementia Rating Scale
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Detailed 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.
Investigators
Poosanu Thanapornsangsuth
Doctor
King Chulalongkorn Memorial Hospital
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Changes in Sum of Boxes of the Clinical Dementia Rating Scale
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.
Progression to dementia
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.
Secondary Outcomes
- Biological diagnosis of Alzheimer's disease(within 6 months of baseline measurement)
- Changes in the Mini Mental State Examination(At 2, 4, 6 and 8 years)
- Changes in the Montreal Cognitive Assessment(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)
- Biological staging of Alzheimer's disease(within 6 months of baseline measurement)
- Future diagnosis of Alzheimer's disease dementia.(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 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) Verbal Paired Associates Scaled Score(At 2, 4, 6 and 8 years)
- Quantitative amyloid PET uptake.(within 6 months of baseline measurement)
- Quantitative tau PET uptake in various cortical regions.(within 6 months of baseline measurement)