Exploring the Diagnostic Biomarkers of Cognitive Disorders in China

NCT ID: NCT06419101

Last Updated: 2024-11-14

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 3000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-30
• Study Completion Date: 2035-05-10

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.

Detailed Description

The 3000 patients with pre-dementia stage and different dementia subtypes will be enrolled in this study, and data will be collected in the baseline including demographics, clinical symptoms, assessment of neuropsychology, neuroimaging, neuroelectrophysiology, blood samples, cerebrospinal fluid, etc. The changes of these data were dynamically observed through an annual follow-up. According to the neuropsychological evaluation results of follow-up, the subjects were divided into dementia progression (dementia-P) and dementia stabilization (dementia-S). Difference in clinical phenotype, neuropsychology, electrophysiology, neuroimaging, and body fluid multi-omics indicators between the two subtypes were compared and analyzed. The neuropsychological testes in patients with dementia included some neuropsychological scales such as, Clinical Dementia Rating (CDR), Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), etc. Multi-model neuroimaging evaluation screen the candidate neuroimaging markers, including structure and functional brain magnetic resonance imaging (MRI), Diffusion tensor image (DTI), 18 F-2-fluro-D-deoxy-glucose-positron emission tomography (18F-FDG-PET)，Amyloid-PET and tau-PET. To exploring neuroelectrophysiology biomarkers collect the data on polysomnography, resting state electroencephalogram, and evoked potentials (P1, N1, P2, N2, etc.). ELISA, SIMOA and other analytical methods were used to detect the contents related to dementia progression in the blood, cerebrospinal fluid, urine, saliva and feces. Multi-dimensional screening and identifying biomarkers of disease diagnosis and progression in all stages, from subjective cognitive impairment to mild cognitive impairment to dementia, in line with the characteristics of the Chinese population.

Conditions

Biomarkers; Dementia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

dementia progression

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

No interventions assigned to this group

dementia stabilization

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

First Hospital of Shijiazhuang City

OTHER

Sponsor Role: collaborator

Chongqing Medical University

OTHER

Sponsor Role: collaborator

Tianjin Huanhu Hospital

OTHER

Sponsor Role: collaborator

Qianfoshan Hospital

OTHER

Sponsor Role: collaborator

Cuibai Wei，Clinical Professor

OTHER

Sponsor Role: lead

Responsible Party

Cuibai Wei，Clinical Professor

Xuanwu Hospital, Capital Medical University

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Cuibai Wei

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Capital Medical University Xuanwu Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Cuibai Wei

Role: CONTACT

weicb@xwhosp.org

83198319

Facility Contacts

Cuibai Wei, Ph.D

Role: primary

Other Identifiers

KS2024051

Identifier Type: -

Identifier Source: org_study_id