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NCT Number: NCT05023564

PUMCH Dementia Longitudinal Cohort Study

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

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Key information

Conditions

Dementia Alzheimer Disease Arterial Occlusive Diseases Arteriosclerosis Basal Ganglia Diseases Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Dementia Alzheimers Dementia Frontal Dementia With Lewy Bodies Dementia, Mild Dementia, Mixed Dementia, Vascular Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Intracranial Arterial Diseases Intracranial Arteriosclerosis Leukoencephalopathies Lewy Body Disease Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Mental Disorders Mixed Dementias Movement Disorders Neoplasms Neoplasms by Histologic Type Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies Tauopathies Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking Union Medical College Hospital

Beijing, China

Location status: Recruiting

Location contact

Chenhui Mao, Doctor

CONTACT

[email protected]

Jing Gao, Doctor

CONTACT

[email protected]

About this study

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:

  • Explore the relationship between lifestyles, stress and dementia.
  • Assess risk factors for dementia.
  • Evaluating behavioral and psychological symptoms of dementia.
  • Improve the long-term follow-up cohort stratified by age and dementia type and construct the high standard information and sample bank.
  • 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.
  • Establish and promote standardized and consistent biomarker detection methods.
  • Dementia education and training.
  • Use machine learning methods to establish computer-assisted dementia diagnosis system and evaluation system. Establish prediction models for the progression of dementia.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. Cognitive decline

    Time frame: Through study completion,an average of 10-20 years

    Use a systematic neuropsychological battery designed by PUMCH

  5. Functional decline

    Time frame: Through study completion,an average of 10-20 years

    Use Activity of Daily Living Scale（ADL）

  6. 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.

  7. 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.

  8. 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.

  9. 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

  10. 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

  11. CSF collection for assessing new dementia biomarker

    Time frame: Through study completion,an average of 10 years

    Use collected CSF to assess new biomarkers.

  12. Serum collection for assessing new dementia biomarker

    Time frame: Through study completion,an average of 10 years

    Use collected serum to assess new biomarkers.

  13. Urine collection for assessing new dementia biomarker

    Time frame: Through study completion,an average of 10 years

    Use collected urine to assess new biomarkers.

  14. Skin collection for assessing new dementia biomarker

    Time frame: Through study completion,an average of 10 years

    Use collected skin for finding new biomarkers.

  15. Biomarker differences of dementia

    Time frame: 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

    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

  17. 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

  18. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Chenhui Mao, Doctor

CONTACT

[email protected]

+86018611895308

Jing Gao, Doctor

CONTACT

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2040
Study completion
2040
First posted
Aug 26, 2021
Registry last updated
Sep 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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