Clinical trial NCT05023564: PUMCH Dementia Longitudinal Cohort Study
Official title: Peking Union Medical College Hospital (PUMCH) Dementia Longitudinal Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dementia
Dementia, Vascular
Dementia With Lewy Bodies
Dementia, Mixed
Dementia Alzheimers
Dementia Frontal
Dementia, Mild
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2021-08-26
Enrollment: 20000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We included age stratified dementia (early onset, late onset, oldest old) , including AD, FTD,VaD, DLB and mixed dementia. Also we include cognitive normal controls.

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.

Eligibility 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

Primary outcomes:
measure: The incidence of dementia
timeFrame: Through study completion,an average of 10-20 years
measure: The relationship between lifestyles, stress (stressful events and their degree) and dementia
timeFrame: Through study completion,an average of 10 years
measure: Risk factors for dementia
timeFrame: Through study completion,an average of 10-20 years
measure: Cognitive decline
timeFrame: Through study completion,an average of 10-20 years
measure: Functional decline
timeFrame: Through study completion,an average of 10-20 years
measure: Changes in the Neuropsychiatric Index (NPI)
timeFrame: Through study completion,an average of 10 years
measure: Changes in the Hospital Anxiety and Depression scale (HAD)
timeFrame: Through study completion,an average of 10 years
measure: Changes in the Cornell Scale for dementia
timeFrame: Through study completion,an average of 10 years
measure: Tau and Beta-amyloid biomarkers in CSF
timeFrame: Through study completion,an average of 10 years
measure: Tau biomarkers in serum
timeFrame: Through study completion,an average of 10 years
measure: CSF collection for assessing new dementia biomarker
timeFrame: Through study completion,an average of 10 years
measure: Serum collection for assessing new dementia biomarker
timeFrame: Through study completion,an average of 10 years
measure: Urine collection for assessing new dementia biomarker
timeFrame: Through study completion,an average of 10 years
measure: Skin collection for assessing new dementia biomarker
timeFrame: Through study completion,an average of 10 years
measure: Biomarker differences of dementia
timeFrame: Through study completion,an average of 10 years
measure: Incorporating age stratified biomarkers into the diagnosis of dementia
timeFrame: Through study completion,an average of 10 years
measure: Dementia education and training
timeFrame: Through study completion,an average of 10 years
measure: Dementia diagnosis system and evaluation system
timeFrame: Through study completion,an average of 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
affiliation: Peking Union Medical College Hospital
name: Chenhui Mao, Doctor
role: PRINCIPAL_INVESTIGATOR
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