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临床试验/NCT06375213
NCT06375213招募中不适用

Investigating Neurocognitive Disorders Epidemiology

King Chulalongkorn Memorial Hospital1 个研究点 分布在 1 个国家目标入组 990 人开始时间: 2023年8月24日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
990
试验地点
1
主要终点
Changes in Sum of Boxes of the Clinical Dementia Rating Scale

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
35 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Changes in Sum of Boxes of the Clinical Dementia Rating Scale

时间窗: 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

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Poosanu Thanapornsangsuth

Doctor

King Chulalongkorn Memorial Hospital

研究点 (1)

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