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PUMCH Dementia Longitudinal Cohort Study

Peking Union Medical College Hospital (PUMCH) Dementia Longitudinal Cohort Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05023564
Enrollment
20000
Registered
2021-08-26
Start date
2020-12-01
Completion date
2040-12-31
Last updated
2022-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia, Dementia Alzheimers, Dementia Frontal, Dementia, Mild, Dementia, Mixed, Dementia, Vascular, Dementia With Lewy Bodies

Brief summary

The PUMCH Dementia Cohort is a hospital-based, observational study of Chinese elderly with cognitive impairment.

Detailed description

In China, the burden of dementia is increasing, which has a major impact on medical care, society, and the economy. In order to solve this important public health problem, a cohort study of cognitive impairment in the elderly should be carried out. We designed an age stratified dementia cohort and tried to to clarify the risk and prognostic factors, disease characteristics, cognitive evaluation, biomarkers, diagnosis, treatment of dementia and its subtypes in China. It is of great significance to establish a relatively comprehensive dementia database, improve the level of clinical diagnosis and treatment of cognitive impairment, and formulate prevention and treatment strategies for dementia. Baseline data collection and cohort establishing: Detailed clinical information including demographic data, clinical history, past history and physical examination are collected. Formatted neuropsychological battery is used in all patients, including screening tests (MMSE, MoCA-PUMCH, ADL, HAD) and domain specific evaluation (Memory, executive function, visual spatial, calculation, language). Samples including serum, CSF, urine, skin, saliva are stored. Every patient is followed up every 6 months. Autopsy brain tissue will be collected if patients died. The main contents of this study are following: 1. Explore the relationship between lifestyles, stress and dementia. 2. Assess risk factors for dementia. 3. Evaluating behavioral and psychological symptoms of dementia. 4. Improve the long-term follow-up cohort stratified by age and dementia type and construct the high standard information and sample bank. 5. Explore biomarkers of different groups of dementia, incorporating neuropsychology, multi-model neuroimaging, metabolics and proteomics based fluid biomarkers as well as genetic biomarkers. Autopsy after clinical follow up help to verify the biomarkers. 6. Establish and promote standardized and consistent biomarker detection methods. 7. Dementia education and training. 8. Use machine learning methods to establish computer-assisted dementia diagnosis system and evaluation system. Establish prediction models for the progression of dementia.

Interventions

None listed

Sponsors

Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Neurodegenerative dementia diagnosis based on 2011 NIA-AA criteria of Dementia * Fixed care giver and can follow up regularly

Exclusion criteria

* Not demented, including MCI * Systemic severe diseases and severe vision or hearing problem effecting follow up and neuropsychological evaluation * Without fixed care giver * Reject informed consent * Expected life shorter than 2 years

Design outcomes

Primary

MeasureTime frameDescription
Tau biomarkers in serumThrough study completion,an average of 10 yearsConcentration ( pg/mL) of tau in serum of patients with dementia and controls
CSF collection for assessing new dementia biomarkerThrough study completion,an average of 10 yearsUse collected CSF to assess new biomarkers.
Serum collection for assessing new dementia biomarkerThrough study completion,an average of 10 yearsUse collected serum to assess new biomarkers.
Urine collection for assessing new dementia biomarkerThrough study completion,an average of 10 yearsUse collected urine to assess new biomarkers.
Skin collection for assessing new dementia biomarkerThrough study completion,an average of 10 yearsUse collected skin for finding new biomarkers.
The incidence of dementiaThrough study completion,an average of 10-20 yearsThrough follow up of cognitive normal control ,to find the incidence of dementia in PUMCH cohort
The relationship between lifestyles, stress (stressful events and their degree) and dementiaThrough study completion,an average of 10 yearsAnalysis of the relationship between lifestyles, stress and progression of dementia. Discover lifestyle factors (such as diet, residential environment, physical activity, hobbies, and sleep) and stress (stressful events and their degree) by using a questionnaire designed by PUMCH
Risk factors for dementiaThrough study completion,an average of 10-20 yearsCollect the risk factors in normal control and analysis the relationship after diagnosis of dementia
Cognitive declineThrough study completion,an average of 10-20 yearsUse a systematic neuropsychological battery designed by PUMCH
Functional declineThrough study completion,an average of 10-20 yearsUse Activity of Daily Living Scale(ADL)
Changes in the Neuropsychiatric Index (NPI)Through study completion,an average of 10 yearsIn dementia patients, analysis their behavioral and psychological symptoms and the related factor. Discover the relationship between behavioral and psychological symptoms and biomarkers for dementia.
Changes in the Hospital Anxiety and Depression scale (HAD)Through study completion,an average of 10 yearsIn dementia patients, analysis their behavioral and psychological symptoms and the related factor. Discover the relationship between behavioral and psychological symptoms and biomarkers for dementia.
Changes in the Cornell Scale for dementiaThrough study completion,an average of 10 yearsIn dementia patients, analysis their behavioral and psychological symptoms and the related factor. Discover the relationship between behavioral and psychological symptoms and biomarkers for dementia.
Tau and Beta-amyloid biomarkers in CSFThrough study completion,an average of 10 yearsConcentration ( pg/mL) of beta-amyloid, tau and phospho-tau in cerebrospinal fluid (CSF) of patients with dementia and controls
Biomarker differences of dementiaThrough study completion,an average of 10 yearsThe differences of biomarkers in patients with different dementia.
Incorporating age stratified biomarkers into the diagnosis of dementiaThrough study completion,an average of 10 yearsComparing the relationships between biomarkers and clinical presentations. Incorporate biomarkers into the accurate and early diagnosis of dementia
Dementia education and trainingThrough study completion,an average of 10 yearsObserve the function of education and training in the treatment and care of dementia patients
Dementia diagnosis system and evaluation systemThrough study completion,an average of 10 yearsUse machine learning methods to establish computer-assisted dementia diagnosis system and evaluation system. Establish prediction models for the progression of dementia

Countries

China

Contacts

Primary ContactChenhui Mao, Doctor
maochenhui@pumch.cn+86018611895308
Backup ContactJing Gao, Doctor

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026