Exploring the Diagnostic Biomarkers of Cognitive Disorders in China

May 21, 2024 updated by: Cuibai Wei，Clinical Professor

Cohort Study on Biomarkers of Cognitive Disorders in China

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.

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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）

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of change in global cognition as measured by Clinical Dementia Rating (CDR).
Time Frame: 10 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of change in global cognition as measured by Mini-Mental State Examination (MMSE)
Time Frame: 10 years
Assess statistically significant difference in score between dementia-P and dementia-S using the neuropsychological scales MMSE. MMSE scores range from 0-30, with higher scores representing better cognitive function.
10 years
Rate of change in global cognition as measured by Montreal Cognitive Assessment (MoCA)
Time Frame: 10 years
Assess statistically significant difference in score between dementia-P and dementia-S using the neuropsychological scales MoCA. MoCA scores range from 0-30, with higher scores representing better cognitive function.
10 years
Rate of change in the severity of cognitive impairment as assessed by Alzheimer's Disease Assessment Scale-Cognitive section (ADAS-cog).
Time Frame: 10 years
Assess statistically significant difference in score between dementia-P and dementia-S using the neuropsychological scales ADAS-cog. ADAS-cog scores range from 0-70, with higher scores indicating better global cognitive function.
10 years
Rate of change in language function as assessed by Boston Naming Test (BNT).
Time Frame: 10 years
Assess statistically significant difference in score between dementia-P and dementia-S using the neuropsychological scales like BNT. BNT scores range from 0-30, with higher scores representing better language function.
10 years
Rate of change in psychobehavioral symptoms as assessed by Neuropsychiatric Inventory (NPI).
Time Frame: 10 years
Assess statistically significant difference in score between dementia-P and dementia-S using the neuropsychological scales like NPI. Patient assessment grading scores range from 0-144 in NPI, and caregivers distress grading scores range from 0-60, with 0 representing the best.
10 years
Rate of change in activities of daily living as assessed by Alzheimer's Disease Cooperative Study-Activity of Daily Living (ADCS-ADL).
Time Frame: 10 years
Assess statistically significant difference between in score dementia-P and dementia-S using the neuropsychological scales like ADCS-ADL. ADCS-ADL scores range from 0-54, with higher scores indicating better completion ability.
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).
Time Frame: 10 years
Assess statistically significant difference in score between dementia-P and dementia-S using the neuropsychological scales like WHO-UCLA AVLT. WHO-UCLA AVLT scores depend on the number of correct words, which ranges from 0-15, with higher scores representing better memory function.
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cuibai Wei，Clinical Professor

Collaborators

Chongqing Medical University
First Hospital of Shijiazhuang City
Tianjin Huanhu Hospital
Central hospital Affiliated to Shandong First Medical University

Investigators

  • Principal Investigator: Cuibai Wei, Xuan Wu Hospital of Capital Medical University, Beijing, China, 100053

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 30, 2024

Primary Completion (Estimated)

May 10, 2034

Study Completion (Estimated)

May 10, 2035

Study Registration Dates

First Submitted

May 7, 2024

First Submitted That Met QC Criteria

May 13, 2024

First Posted (Actual)

May 17, 2024

Study Record Updates

Last Update Posted (Actual)

May 22, 2024

Last Update Submitted That Met QC Criteria

May 21, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KS2024051

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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