🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT03653156
Recruiting Observational

China Cognition and Aging Study

NCT03653156 · tracked via the Priya Life Science China tracker
Sponsor
Capital Medical University
Phase
Observational
Started
2000-01-01
Last updated
2026-03-23

Condition(s) studied

Mild Cognitive Impairment(MCI)Alzheimer Disease, Late OnsetFamilial Alzheimer Disease (FAD)Vascular Dementia (VaD)Normal ControlNon-Alzheimer Degenerative Dementia

Study summary

The aim of this study is to establish and perfect the China Cognition and Aging Study (China COAST) cohort, to clarify the epidemiology, influencing factors, genetic characteristics, pathogenesis, disease characteristics and diagnosis and treatment status of dementia and its subtypes in China. It is of great significance to establish a relatively comprehensive national database of cognitive disorders, improve the clinical diagnosis and treatment level of cognitive disorders, and formulate prevention and treatment strategies for dementia. The primary aims of China COAST are as follows:

1. To use the prospective cohort to establish a large database research platform, so as to provide comprehensive epidemiological data, clinical and neuropsychological evaluation data, biological samples, and laboratory tests and imaging data.
2. To update the prevalence and incidence rate of dementia and its subtypes every 2-3 years, and clarify the conversion pattern from normal elderly to MCI and from MCI to dementia.
3. To explore the known or unknown protective and risk factors of dementia and its major subtypes (AD, VaD, other dementia).
4. To discover new pathogenic genes and susceptible genes of dementia and its major subtypes (AD and VaD), as well as new mutation sites of known pathogenic genes. To study the genetic variation, mutation and polymorphism of PSEN1, PSEN2, APP and APOE genes in dementia patients, and to understand their distribution and roles in the pathogenesis.
5. To study the biomarkers (body fluid, genetics, imaging) with diagnostic value of MCI, AD (sporadic and familial) and VaD, to define their cut-off values, and to establish prediction models.
6. To study the diagnostic criteria of cognitive normal, MCI, dementia and their subtypes (clinical and molecular subtypes) in the cohort, and to make psychological assessment scales with high sensitivity and specificity, and in line with the characteristics of Chinese people.
7. To find potentially modifiable risk factors for dementia and to study the prevention and intervention effect of non-pharmacological treatment on APOE ε4 carriers, MCI and AD or other dementia patients,which included improvements in education, nutrition, health care, and lifestyle changes. This needs a long time follow-up.
8. To explore the relationship between dementia as well as its major subtype AD and cerebral and systemetic circulatory disorders (for example, mixed dmentia), as well as potential therapeutic strategies.
9. To carry out investigation and researches about dementia related education, improve the awareness of dementia, and strengthen the management of dementia.
10. To investigate the level of stigma and discrimination and its influencing factors in patients with Alzheimer's disease and their caregivers.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Community population: age ≥ 55 years, male or female, with consent to participant the study. Hospital population: subjects are all over 18 years old. Through clinical evaluation, neuropsychological test, imaging examination, blood and cerebrospinal fluid examination, etc, we will comprehensively evaluate the cognitive function and various test measures. (1) MCI and its subtypes Inclusion criteria: 1. Diagnosis according to 2004 Peterson's MCI criteria. 2. CDR = 0.5. 3. Memory loss is prominent, and may also be with other cognitive domain dysfunction. 4. Insidious onset, slow progress. 5. Not reaching the level of dementia. Exclusion criteria: 1. With history of stroke and a neurological focal sign, the imaging findings are consistent with cerebral small vessal disease (Fazekas score ≥ 2 points). 2. Other neurological diseases that can cause brain dysfunction (such as depression, brain tumor, Parkinson's disease, metabolic encephalopathy, encephalitis, multiple sclerosis, epilepsy, brain trauma, normal intracranial pressure hydrocephalus, etc.). 3. Other systemic diseases that can cause cognitive impairment (such as liver, renal and thyroid insufficiency, severe anemia, folic acid or vitamin B12 deficiency, syphilis, HIV infection, alcohol and drug abuse, etc.). 4. Mental and neurodevelopmental retardation. 5. Contraindications to MRI. 6. Suffering from a disease that cannot be combined with cognitive examination. 7. Refuse to draw blood. 8. Refuse to sign the informed consent at baseline (2) Sporadic Alzheimer's disease (SAD) Inclusion criteria: 1. Dementia is diagnosed according to the criteria described by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-R). The diagnosis of AD is made using the National Institute of Neurologic and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) or National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria. 2. Subjects and their informed persons can complete relevant and follow- up examinations. 3. Subjects or their authorized legal guardians sign the informed consent. Exclusion criteria: 1. With a family history of dementia. 2. Other neurological diseases that can cause brain dysfunction (such as depression, brain tumor, Parkinson's disease, metabolic encephalopathy, encephalitis, multiple sclerosis, epilepsy, brain trauma, normal intracranial pressure hydrocephalus, etc.). 3. Other systemic diseases that can cause cognitive impairment (such as liver, renal and thyroid insufficiency, severe anemia, folic acid or vitamin B12 deficiency, syphilis, HIV infection, alcohol and drug abuse, etc.). 4. Mental and neurodevelopmental retardation. 5. Contraindications to MRI. 6. Suffering from a disease that cannot be combined with cognitive examination. 7. Refuse to draw blood. 8. Refuse to sign the informed consent at baseline (3) Familial Alzheimer's disease (FAD) Inclusion criteria: 1. Written informed consent obtained from participant or legal guardian prior to any study-related procedures. 2. Members in FAD pedigree (FAD is defined as at least two first- degree relatives suffer from AD). 3. Aged 18 (inclusive) or older. 4. At least two persons who can provide reliable information for the study. Note: Dementia is diagnosed according to the criteria described by DSM-IV-R. The diagnosis of AD is made using NINCDS-ADRDA or NIA-AA criteria. A diagnosis of MCI is assigned according to Petersen criteria. Exclusion criteria: 1. Dementia caused by other factors such as depression, other psychiatric illnesses, thyroid dysfunction, encephalitis, multiple sclerosis, brain trauma, brain tumor, syphilis, acquired immunodeficiency syndrome (AIDS), Creutzfeldt-Jakob disease and other types of dementias such as vascular dementia (VaD), frontotemporal dementia (FTD), dementia with Lewy bodies (DLB), and Parkinson's disease dementia (PDD). 2. MRI and laboratory tests do not support or rule out a diagnosis of AD. 3. Severe circulatory, respiratory, urinary, digestive, hematopoietic diseases (such as unstable angina, uncontrollable asthma, active gastric bleeding) and cancer. 4. Participant has severe psychiatric illness or severe dementia that would interfere in completing initial and follow-up clinical assessments. 5. With history of alcohol or drug abuse. 6. Pregnant or lactating women. 7. No reliable insiders. 8. Refuse to sign the informed consent at baseline. (4) Vascular dementia (VaD) Inclusion criteria: Diagnosis for probable VaD according to NINDS-AIREN diagnostic criteria. MRI inclusion criteria: All patients who meet clinical inclusion criteria should accept MRI scans which include an assessment of hippocampal volume. 1. multiple (≥3) supratentorial subcortical small infarcts (3-20 mm in diameter) with or without any degree of white matter lesion (WML); or moderate to severe WML (Fazekas score ≥ 2), with or without small infarction; or ≥ 1 subcortical small infarct in key regions, such as caudate nucleus, globus pallidus, or thalamus. 2. no cortical and watershed infarction, hemorrhage, hydrocephalus, or WML with specific causes (such as multiple sclerosis). 3. no hippocampus or entorhinal cortex atrophy (MTA score = 0 point). Exclusion criteria: 1. Other neurological diseases that can cause brain dysfunction (such as depression, brain tumor, Parkinson's disease, metabolic encephalopathy, encephalitis, multiple sclerosis, epilepsy, brain trauma, normal intracranial pressure hydrocephalus, etc.). 2. Other systemic diseases that can cause cognitive impairment (such as liver insufficiency, renal insufficiency, thyroid insufficiency, severe anemia, folic acid or vitamin B12 deficiency, syphilis, HIV infection, alcohol and drug abuse, etc.). 3. With a history of mental illness or those with congenital mental retardation. 4. Suffering from a disease that cannot be combined with a cognitive examination. 5. Contraindications to MRI. 6. Refuse to draw blood. 7. Refuse to sign informed consent. (5) Normal control Inclusion criteria: 1. Aged 18 (inclusive) or above. 2. Normal MMSE and MoCA evaluations. MMSE\>19 points for illiteracy, \>24 points for those educated less than 7 years, \>27 points for those educated equal to or more than 7 years. MoCA\>13 points for illiteracy, \>19 points for those educated less than 7 years, \>24 points for those educated equal to or more than 7 years. Exclusion criteria: 1. Subjects with abnormal MMSE or MoCA scores. 2. Subjects with a history of cerebral infarction, traumatic brain injury or related manifestations in MRI. 3. Other neurological diseases that can cause brain dysfunction (such as depression, brain tumor, Parkinson's disease, metabolic encephalopathy, encephalitis, multiple sclerosis, epilepsy, brain trauma, normal intracranial pressure hydrocephalus, etc.). 4. Other systemic diseases that can cause cognitive impairment (such as liver, renal and thyroid insufficiency, severe anemia, folic acid or vitamin B12 deficiency, syphilis, HIV infection, alcohol and drug abuse, etc.). 5. Mental and neurodevelopmental retardation. 6. Suffering from a disease that cannot be combined with a cognitive examination. 7. Contraindications to MRI. 8. Refuse to draw blood. 9. Refuse to sign the informed consent at baseline.

Primary outcome measure(s)

Trial sites (65)

FacilityCityRegionStatus
The First Affiliated Hospital of Anhui Medical University Hefei Anhui Recruiting
Beijing Geriatric Hospital Changping Beijing Municipality Recruiting
Beijing Chao Yang Hospital Chaoyang Beijing Municipality Recruiting
China-Japan Friendship Hospital Chaoyang Beijing Municipality Recruiting
Dongfang Hospital Affiliated to Beijing University of Chinese Medicine Fengtai Beijing Municipality Recruiting
Chinese PLA General Hospital Haidian Beijing Municipality Recruiting
Fu Xing Hospital, Capital Medical University Haidian Beijing Municipality Recruiting
Peking University Third Hospital Haidian Beijing Municipality Recruiting
Peking Union Medical College Hospital Xicheng Beijing Municipality Recruiting
Peking University First Hospital Xicheng Beijing Municipality Recruiting
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University Yuzhong Chongqing Municipality Recruiting
The Second Affiliated Hospital of Chongqing Medical University Yuzhong Chongqing Municipality Recruiting
Fujian Medical University Union Hospital Fujian Guangdong Recruiting
Guangzhou Psychiatric Hospital Guangzhou Guangdong Recruiting
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Zhongshan Guangdong Recruiting
First Affiliated Hospital of Guangxi Medical University Nanning Guangxi Recruiting
The Affiliated Hospital Of Guizhou Medical University Guiyang Guizhou Recruiting
Handan Central Hospital Handan Hebei Recruiting
First Hospital of Shijiazhuang City Shijiazhuang Hebei Recruiting
Tangshan Worker's Hospital Tangshan Hebei Recruiting
Hebei General Hospital Zhijiazhuang Hebei Recruiting
First Affiliated Hospital of Harbin Medical University Haerbin Heilongjiang Recruiting
Kaifeng Central Hospital Kaifeng Henan Recruiting
Henan Provincial People's Hospital Zhengzhou Henan Recruiting
People's Hospital of Zhengzhou Zhengzhou Henan Recruiting
People's Hospital Affiliated Hubei Medical University Wuhan Hubei Recruiting
Tongji Hospital Wuhan Hubei Recruiting
The Third Xiangya Hospital of Central South University Wuhan Hunan Recruiting
Wuhan University Zhongnan Hospital Wuhan Hunan Recruiting
Xiangya Hospital of Central South University Wuhan Hunan Recruiting
Nantong University Affiliated Hospital Nantong Jiangsu Recruiting
Subei People's Hospital of Jiangsu Subei Jiangsu Recruiting
Mineral General Hospital, Xuzhou Xuzhou Jiangsu Recruiting
Jiangxi Provincial People's Hospital Nanchang Jiangxi Recruiting
China-Japan friendship Hospital of Jilin university Changchun Jilin Recruiting
The First Hospital of Jilin University Changchun Jilin Recruiting
Changda Hospital, Anshan Anshan Liaoning Recruiting
Affiliated Zhongshan hospital of Dalian university Dalian Liaoning Recruiting
The First Affiliated Hospital of Dalian Medical University Dalian Liaoning Recruiting
First Hospital of China Medical University Shenyang Liaoning Recruiting

+ 25 more sites — see the full list on the official registry below.

More Capital Medical University trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03653156 on ClinicalTrials.gov ↗ ← All trials in China