PUMCH Dementia Longitudinal Cohort Study

September 10, 2022 updated by: Peking Union Medical College Hospital

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

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

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

20000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Jing Gao, Doctor

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Peking Union Medical College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of dementia
Time Frame: 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
Through study completion,an average of 10-20 years
The relationship between lifestyles, stress (stressful events and their degree) and dementia
Time Frame: 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
Through study completion,an average of 10 years
Risk factors for dementia
Time Frame: Through study completion,an average of 10-20 years
Collect the risk factors in normal control and analysis the relationship after diagnosis of dementia
Through study completion,an average of 10-20 years
Cognitive decline
Time Frame: Through study completion,an average of 10-20 years
Use a systematic neuropsychological battery designed by PUMCH
Through study completion,an average of 10-20 years
Functional decline
Time Frame: Through study completion,an average of 10-20 years
Use Activity of Daily Living Scale（ADL）
Through study completion,an average of 10-20 years
Changes in the Neuropsychiatric Index (NPI)
Time Frame: 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.
Through study completion,an average of 10 years
Changes in the Hospital Anxiety and Depression scale (HAD)
Time Frame: 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.
Through study completion,an average of 10 years
Changes in the Cornell Scale for dementia
Time Frame: 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.
Through study completion,an average of 10 years
Tau and Beta-amyloid biomarkers in CSF
Time Frame: 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
Through study completion,an average of 10 years
Tau biomarkers in serum
Time Frame: Through study completion,an average of 10 years
Concentration ( pg/mL) of tau in serum of patients with dementia and controls
Through study completion,an average of 10 years
CSF collection for assessing new dementia biomarker
Time Frame: Through study completion,an average of 10 years
Use collected CSF to assess new biomarkers.
Through study completion,an average of 10 years
Serum collection for assessing new dementia biomarker
Time Frame: Through study completion,an average of 10 years
Use collected serum to assess new biomarkers.
Through study completion,an average of 10 years
Urine collection for assessing new dementia biomarker
Time Frame: Through study completion,an average of 10 years
Use collected urine to assess new biomarkers.
Through study completion,an average of 10 years
Skin collection for assessing new dementia biomarker
Time Frame: Through study completion,an average of 10 years
Use collected skin for finding new biomarkers.
Through study completion,an average of 10 years
Biomarker differences of dementia
Time Frame: Through study completion,an average of 10 years
The differences of biomarkers in patients with different dementia.
Through study completion,an average of 10 years
Incorporating age stratified biomarkers into the diagnosis of dementia
Time Frame: 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
Through study completion,an average of 10 years
Dementia education and training
Time Frame: Through study completion,an average of 10 years
Observe the function of education and training in the treatment and care of dementia patients
Through study completion,an average of 10 years
Dementia diagnosis system and evaluation system
Time Frame: 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
Through study completion,an average of 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2020

Primary Completion (ANTICIPATED)

December 31, 2040

Study Completion (ANTICIPATED)

December 31, 2040

Study Registration Dates

First Submitted

July 31, 2021

First Submitted That Met QC Criteria

August 20, 2021

First Posted (ACTUAL)

August 26, 2021

Study Record Updates

Last Update Posted (ACTUAL)

September 13, 2022

Last Update Submitted That Met QC Criteria

September 10, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PUMCH Dementia Cohort

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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