China Cognition and Aging Study: a Multi-center, National-wide, Longitudinal Study in China

Plain English Summary

China Cognition and Aging Study is a Not Applicable clinical trial sponsored by Capital Medical University studying Mild Cognitive Impairment(MCI), Alzheimer Disease, Late Onset, Familial Alzheimer Disease (FAD), Vascular Dementia (VaD), Normal Control, Non-Alzheimer Degenerative Dementia. This study aims to build a large database of cognitive health in China to better understand dementia and related conditions. It is looking for a wide range of participants, from healthy older adults to those with mild cognitive impairment or different types of dementia. Participation involves regular check-ups, cognitive tests, and potentially providing biological samples for research. There are no direct treatments being tested in this observational study; it focuses on understanding the conditions. The trial aims to enroll 100000 participants.

Official 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

Who Can Participate

Here is what you need to know about eligibility for this trial. Healthy individuals aged 55 and older who can give consent. Individuals aged 18 and older diagnosed with Mild Cognitive Impairment (MCI) or specific types of dementia (Alzheimer's, Vascular Dementia) who can provide consent and undergo evaluations. Individuals with a family history of Alzheimer's disease (for Familial Alzheimer's study). People with certain neurological conditions (like stroke with focal signs, Parkinson's, brain tumors), severe systemic illnesses, or those who cannot undergo MRI or blood draws may not be eligible. This trial is studying Mild Cognitive Impairment(MCI), Alzheimer Disease, Late Onset, Familial Alzheimer Disease (FAD), Vascular Dementia (VaD), Normal Control, Non-Alzheimer Degenerative Dementia, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The study will track how common cognitive decline is, how quickly it progresses, and identify factors that might predict or protect against it, ultimately helping to develop better ways to manage thes The specific primary outcome measures are: The prevalence of MCI and AD measured using a population-based cross-sectional survey with a multistage cluster sampling design (an average of 2 years); The conversion rate of normal to MCI to AD in Chinese (an average of 2 years); The biomarkers for normal (pre-MCI), MCI and AD diagnosis (an average of 2 years); The risk factors (genetic and environmental factors) for MCI, AD and VCI at genomic and expression levels (an average of 2 years); The effective non-pharmacologic treatment(NPT) intervention (an average of 2 years). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This study is crucial for building a comprehensive understanding of dementia and cognitive aging in China, aiming to improve diagnosis, treatment, and prevention strategies for a growing elderly popul This research targets Mild Cognitive Impairment(MCI), Alzheimer Disease, Late Onset, Familial Alzheimer Disease (FAD), Vascular Dementia (VaD), Normal Control, Non-Alzheimer Degenerative Dementia, where improved treatment options are needed.

Investor Insight

This large-scale, long-term observational study by Capital Medical University aims to create a foundational dataset for dementia research in China, potentially guiding future drug development and diag The large enrollment target of 100000 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor if your cognitive changes might be related to MCI or dementia and if this study is a good fit for you. Be prepared for regular visits that will include cognitive assessments, medical evaluations, and possibly blood tests or brain imaging. Understand that this is an observational study, meaning it focuses on collecting data rather than providing a direct treatment. This trial is currently recruiting participants. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: OBSERVATIONAL
• Enrollment: 100,000 participants

Primary Outcomes

• The prevalence of MCI and AD measured using a population-based cross-sectional survey with a multistage cluster sampling design (an average of 2 years)
• The conversion rate of normal to MCI to AD in Chinese (an average of 2 years)
• The biomarkers for normal (pre-MCI), MCI and AD diagnosis (an average of 2 years)
• The risk factors (genetic and environmental factors) for MCI, AD and VCI at genomic and expression levels (an average of 2 years)
• The effective non-pharmacologic treatment(NPT) intervention (an average of 2 years)

Full Eligibility Criteria

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

Trial Locations

• The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China
• Beijing Geriatric Hospital, Changping, Beijing Municipality, China
• Beijing Chao Yang Hospital, Chaoyang, Beijing Municipality, China
• China-Japan Friendship Hospital, Chaoyang, Beijing Municipality, China
• Dongfang Hospital Affiliated to Beijing University of Chinese Medicine, Fengtai, Beijing Municipality, China
• Chinese PLA General Hospital, Haidian, Beijing Municipality, China
• Fu Xing Hospital, Capital Medical University, Haidian, Beijing Municipality, China
• Peking University Third Hospital, Haidian, Beijing Municipality, China
• Peking Union Medical College Hospital, Xicheng, Beijing Municipality, China
• Peking University First Hospital, Xicheng, Beijing Municipality, China
• ...and 10 more locations

Frequently Asked Questions

Related Conditions

• Mild Cognitive Impairment (MCI)
• Alzheimer's Disease
• Vascular Dementia
• Dementia
• Cognitive Impairment
• Aging
• Neurological Disorders
• Neurodegenerative Diseases
• Geriatrics
• Public Health

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