PUMCH Dementia Longitudinal Cohort Study

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05023564
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Peking Union Medical College Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Chenhui Mao, Doctor
Principal Investigator Affiliation	Peking Union Medical College Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Dementia, Dementia, Vascular, Dementia With Lewy Bodies, Dementia, Mixed, Dementia Alzheimers, Dementia Frontal, Dementia, Mild

Additional Details

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.

Arms & Interventions

Arms

: Early onset dementia

Dementia patients with onset age lower than 65y/o

: Late onset dementia

Dementia patients with onset age between 65y/o and 85y/o

: Oldest old dementia

Dementia patients with onset age older than 85y/o

: Cognitive normal control

Normal Aging with normal cognitive function

Interventions

Contact a Trial Team

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International Sites

Peking Union Medical College Hospital, Beijing 1816670, China

Status

Recruiting

Address

Peking Union Medical College Hospital

Beijing 1816670, ,

Site Contact

Chenhui Mao, Doctor

[email protected]

+86018611895308

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