PUMCH Dementia Longitudinal Cohort Study

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05023564
Collaborator
(none)
20,000
1
241
83

Study Details

Study Description

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
20000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Peking Union Medical College Hospital (PUMCH) Dementia Longitudinal Cohort Study
Actual Study Start Date :
Dec 1, 2020
Anticipated Primary Completion Date :
Dec 31, 2040
Anticipated Study Completion Date :
Dec 31, 2040

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. The incidence of dementia [Through study completion,an average of 10-20 years]

    Through follow up of cognitive normal control ,to find the incidence of dementia in PUMCH cohort

  2. The relationship between lifestyles, stress (stressful events and their degree) and dementia [Through study completion,an average of 10 years]

    Analysis 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

  3. Risk factors for dementia [Through study completion,an average of 10-20 years]

    Collect the risk factors in normal control and analysis the relationship after diagnosis of dementia

  4. Cognitive decline [Through study completion,an average of 10-20 years]

    Use a systematic neuropsychological battery designed by PUMCH

  5. Functional decline [Through study completion,an average of 10-20 years]

    Use Activity of Daily Living Scale(ADL)

  6. Changes in the Neuropsychiatric Index (NPI) [Through study completion,an average of 10 years]

    In dementia patients, analysis their behavioral and psychological symptoms and the related factor. Discover the relationship between behavioral and psychological symptoms and biomarkers for dementia.

  7. Changes in the Hospital Anxiety and Depression scale (HAD) [Through study completion,an average of 10 years]

    In dementia patients, analysis their behavioral and psychological symptoms and the related factor. Discover the relationship between behavioral and psychological symptoms and biomarkers for dementia.

  8. Changes in the Cornell Scale for dementia [Through study completion,an average of 10 years]

    In dementia patients, analysis their behavioral and psychological symptoms and the related factor. Discover the relationship between behavioral and psychological symptoms and biomarkers for dementia.

  9. Tau and Beta-amyloid biomarkers in CSF [Through study completion,an average of 10 years]

    Concentration ( pg/mL) of beta-amyloid, tau and phospho-tau in cerebrospinal fluid (CSF) of patients with dementia and controls

  10. Tau biomarkers in serum [Through study completion,an average of 10 years]

    Concentration ( pg/mL) of tau in serum of patients with dementia and controls

  11. CSF collection for assessing new dementia biomarker [Through study completion,an average of 10 years]

    Use collected CSF to assess new biomarkers.

  12. Serum collection for assessing new dementia biomarker [Through study completion,an average of 10 years]

    Use collected serum to assess new biomarkers.

  13. Urine collection for assessing new dementia biomarker [Through study completion,an average of 10 years]

    Use collected urine to assess new biomarkers.

  14. Skin collection for assessing new dementia biomarker [Through study completion,an average of 10 years]

    Use collected skin for finding new biomarkers.

  15. Biomarker differences of dementia [Through study completion,an average of 10 years]

    The differences of biomarkers in patients with different dementia.

  16. Incorporating age stratified biomarkers into the diagnosis of dementia [Through study completion,an average of 10 years]

    Comparing the relationships between biomarkers and clinical presentations. Incorporate biomarkers into the accurate and early diagnosis of dementia

  17. Dementia education and training [Through study completion,an average of 10 years]

    Observe the function of education and training in the treatment and care of dementia patients

  18. Dementia diagnosis system and evaluation system [Through study completion,an average of 10 years]

    Use machine learning methods to establish computer-assisted dementia diagnosis system and evaluation system. Establish prediction models for the progression of dementia

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Peking Union Medical College Hospital Beijing China

Sponsors and Collaborators

  • Peking Union Medical College Hospital

Investigators

  • Principal Investigator: Chenhui Mao, Doctor, Peking Union Medical College Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT05023564
Other Study ID Numbers:
  • PUMCH Dementia Cohort
First Posted:
Aug 26, 2021
Last Update Posted:
Aug 26, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 26, 2021