Exploring the Diagnostic Biomarkers of Cognitive Disorders in China

NCT06419101 | Recruiting

• 1 other identifier: KS2024051
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

Dementia is a syndrome characterized by progressive global cognitive impairment that impairs occupational, family, or social functioning. It detrimentally affects personal health and quality of life, imposing significant medical economy, social and psychological burden on the countries and the patients' family. The internationally renowned dementia cohort includes the DIAN that focused on genetics studies, the ADNI cohort featuring imaging and the FINGERS cohort focused on risk factor intervention, etc. Establishing standardized and shared longitudinal follow-up dementia cohorts and clinical database is an essential challenge for constructing dementia cohort in China. Moreover, there is a lack of large-scale prospective longitudinal follow-up cohorts within the Chinese population that cover subjective cognitive decline (SCD) to explore biomarkers with diagnostic and early warning value for different kinds of dementia and pre-dementia stages. The study will rely on the dementia cohort based on Chinese population to explore the biological phenotype characteristics of the pre-dementia stage and different dementia subtypes, and observe the dynamic change rules of the dementia cohort vertically, so as to foster early intervention and improve prognosis for individuals with dementia.

Conditions

Biomarkers; Dementia

Keywords

dementia; diagnostic biomarkers

Outcome Measures

Primary Outcomes (1)

• Rate of change in global cognition as measured by Clinical Dementia Rating (CDR).

  Assess statistically significant difference in score between dementia-P and dementia-S using the neuropsychological scales CDR. CDR, a multidimensional scale for dementia severity, which scored 0-3, with higher scores indicating worse functioning.

  10 years

Secondary Outcomes (7)

• Rate of change in global cognition as measured by Mini-Mental State Examination (MMSE)

  10 years

• Rate of change in global cognition as measured by Montreal Cognitive Assessment (MoCA)

  10 years

• Rate of change in the severity of cognitive impairment as assessed by Alzheimer's Disease Assessment Scale-Cognitive section (ADAS-cog).

  10 years

• Rate of change in memory function as assessed by World Health Organization-University of California, Los Angeles, auditory verbal learning test (WHO-UCLA AVLT).

  10 years

• Rate of change in language function as assessed by Boston Naming Test (BNT).

  10 years

Study Arms (2)

dementia progression

dementia-P (Compared with the baseline, MMSE score declined ≥ 4 points per year)

dementia stabilization

dementia-S (Compared with the baseline, MMSE score decreased \< 4 points per year）

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This project will enroll about 3000 patients with dementia, who meet the inclusion and exclusion criteria, including subjective cognitive decline (SCD), MCI, AD, frontotemporal dementia (FTD), dementia with Lewy bodies (DLB), etc.

You may qualify if:

• Male or female patients aged ≥40 and ≤90years;
• Chief complaint or others describe a cognitive decline;
• Ability to communicate in Chinese;
• The patients and their families were informed and signed the informed consent.

You may not qualify if:

• MMSE\<10;
• There are other neurological diseases that can cause brain dysfunction (such as depression, brain tumors, Parkinson's disease, metabolic encephalopathy, encephalitis, multiple sclerosis, epilepsy, traumatic brain injury, normal intracranial pressure hydrocephalus, etc.);
• There are other systemic diseases that can cause cognitive impairment (such as hepatic insufficiency, renal insufficiency, Thyroid dysfunction, severe anemia, folic acid or vitamin B12 deficiency, syphilis, HIV infection, alcohol and drug abuse, etc.);
• Suffering from a disease that cannot cooperate with the completion of cognitive examination;
• There are contraindications to nuclear magnetic resonance;
• There is mental and neurodevelopmental delay;
• Refuse to draw blood;
• Refuse to sign the informed consent.

Sponsors & Collaborators

• Cuibai Wei，Clinical Professor: lead
• First Hospital of Shijiazhuang City: collaborator
• Chongqing Medical University: collaborator
• Tianjin Huanhu Hospital: collaborator
• Qianfoshan Hospital: collaborator

Study Sites (1)

Capital Medical University Xuanwu Hospital

Beijing, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood samples, CSF, urine, faeces, saliva

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Cuibai Wei

  Xuan Wu Hospital of Capital Medical University, Beijing, China, 100053

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cuibai Wei

CONTACT

83198319; weicb@xwhosp.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Xuanwu Hospital, Capital Medical University

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 17, 2024
• Study Start: May 30, 2024
• Primary Completion (Estimated): May 10, 2034
• Study Completion (Estimated): May 10, 2035
• Last Updated: November 14, 2024

Record last verified: 2024-11

Locations

CN (1)