DementiaNCT05023564
PUMCH Dementia Longitudinal Cohort Study
An observational study of Dementia and Dementia, Vascular, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The PUMCH Dementia Cohort is a hospital-based, observational study of Chinese elderly with cognitive impairment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia, Dementia, Vascular, Dementia With Lewy Bodies
- How many people
- 20,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to 31 Dec 2040
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Neurodegenerative dementia diagnosis based on 2011 NIA-AA criteria of Dementia
- Fixed care giver and can follow up regularly
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jing Gao, Doctor contact
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing
Chenhui Mao, Doctor, maochenhui@pumch.cn
Jing Gao, Doctor, gj107@163.com
About this study
Official title: 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.
Read the 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:
- 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.
- Conditions
- Dementia, Dementia, Vascular, Dementia With Lewy Bodies, Dementia, Mixed, Dementia Alzheimers, Dementia Frontal
- Medical subject headings
- Dementia, Dementia, Vascular, Lewy Body Disease, Mixed Dementias, Alzheimer Disease, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
The incidence of dementia
Through follow up of cognitive normal control ,to find the incidence of dementia in PUMCH cohort
Measured: Through study completion,an average of 10-20 years
The relationship between lifestyles, stress (stressful events and their degree) and dementia
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
Measured: Through study completion,an average of 10 years
Risk factors for dementia
Collect the risk factors in normal control and analysis the relationship after diagnosis of dementia
Measured: Through study completion,an average of 10-20 years
Cognitive decline
Use a systematic neuropsychological battery designed by PUMCH
Measured: Through study completion,an average of 10-20 years
Functional decline
Use Activity of Daily Living Scale（ADL）
Measured: Through study completion,an average of 10-20 years
Changes in the Neuropsychiatric Index (NPI)
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.
Measured: Through study completion,an average of 10 years
Changes in the Hospital Anxiety and Depression scale (HAD)
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.
Measured: Through study completion,an average of 10 years
Changes in the Cornell Scale for dementia
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.
Measured: Through study completion,an average of 10 years
Tau and Beta-amyloid biomarkers in CSF
Concentration ( pg/mL) of beta-amyloid, tau and phospho-tau in cerebrospinal fluid (CSF) of patients with dementia and controls
Measured: Through study completion,an average of 10 years
Tau biomarkers in serum
Concentration ( pg/mL) of tau in serum of patients with dementia and controls
Measured: Through study completion,an average of 10 years
CSF collection for assessing new dementia biomarker
Use collected CSF to assess new biomarkers.
Measured: Through study completion,an average of 10 years
Serum collection for assessing new dementia biomarker
Use collected serum to assess new biomarkers.
Measured: Through study completion,an average of 10 years
Urine collection for assessing new dementia biomarker
Use collected urine to assess new biomarkers.
Measured: Through study completion,an average of 10 years
Skin collection for assessing new dementia biomarker
Use collected skin for finding new biomarkers.
Measured: Through study completion,an average of 10 years
Biomarker differences of dementia
The differences of biomarkers in patients with different dementia.
Measured: Through study completion,an average of 10 years
Incorporating age stratified biomarkers into the diagnosis of dementia
Comparing the relationships between biomarkers and clinical presentations. Incorporate biomarkers into the accurate and early diagnosis of dementia
Measured: Through study completion,an average of 10 years
Dementia education and training
Observe the function of education and training in the treatment and care of dementia patients
Measured: Through study completion,an average of 10 years
Dementia diagnosis system and evaluation system
Use machine learning methods to establish computer-assisted dementia diagnosis system and evaluation system. Establish prediction models for the progression of dementia
Measured: Through study completion,an average of 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start1 Dec 2020
- Primary completion31 Dec 2040 (estimated)
- Study completion31 Dec 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chenhui Mao, Doctor, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05023564
- Sponsor's protocol ID
- PUMCH Dementia Cohort
- Status last verified
- Sep 2022
- First submitted
- 31 Jul 2021
- Last updated
- 13 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jack CR Jr, Bennett DA, Blennow K, Carrillo MC, Dunn B, Haeberlein SB, Holtzman DM, Jagust W, Jessen F, Karlawish J, Liu E, Molinuevo JL, Montine T, Phelps C, Rankin KP, Rowe CC, Scheltens P, Siemers E, Snyder HM, Sperling R; Contributors. NIA-AA Research Framework: Toward a biological definition of Alzheimer's disease. Alzheimers Dement. 2018 Apr;14(4):535-562. doi: 10.1016/j.jalz.2018.02.018.
PubMed 29653606Olsson B, Lautner R, Andreasson U, Ohrfelt A, Portelius E, Bjerke M, Holtta M, Rosen C, Olsson C, Strobel G, Wu E, Dakin K, Petzold M, Blennow K, Zetterberg H. CSF and blood biomarkers for the diagnosis of Alzheimer's disease: a systematic review and meta-analysis. Lancet Neurol. 2016 Jun;15(7):673-684. doi: 10.1016/S1474-4422(16)00070-3. Epub 2016 Apr 8.
PubMed 27068280Norton S, Matthews FE, Barnes DE, Yaffe K, Brayne C. Potential for primary prevention of Alzheimer's disease: an analysis of population-based data. Lancet Neurol. 2014 Aug;13(8):788-94. doi: 10.1016/S1474-4422(14)70136-X.
PubMed 25030513McKhann GM, Albert MS, Grossman M, Miller B, Dickson D, Trojanowski JQ; Work Group on Frontotemporal Dementia and Pick's Disease. Clinical and pathological diagnosis of frontotemporal dementia: report of the Work Group on Frontotemporal Dementia and Pick's Disease. Arch Neurol. 2001 Nov;58(11):1803-9. doi: 10.1001/archneur.58.11.1803.
PubMed 11708987Rosenberg A, Ngandu T, Rusanen M, Antikainen R, Backman L, Havulinna S, Hanninen T, Laatikainen T, Lehtisalo J, Levalahti E, Lindstrom J, Paajanen T, Peltonen M, Soininen H, Stigsdotter-Neely A, Strandberg T, Tuomilehto J, Solomon A, Kivipelto M. Multidomain lifestyle intervention benefits a large elderly population at risk for cognitive decline and dementia regardless of baseline characteristics: The FINGER trial. Alzheimers Dement. 2018 Mar;14(3):263-270. doi: 10.1016/j.jalz.2017.09.006. Epub 2017 Oct 19.
PubMed 29055814Yang X, Wu M, Liang M, Zhang H, Li B, Mao C, Dong L, Wang Y, Xing H, Ren C, Huang Z, Wen Q, Ge Q, Yu Z, Feng F, Gao J, Huo L. Ultra-fast [18F]florbetapir PET imaging using the uMI Panorama PET/CT system. EJNMMI Phys. 2024 Dec 30;11(1):107. doi: 10.1186/s40658-024-00712-5.
PubMed 39738784
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peking Union Medical College Hospital (PUMCH) Dementia Longitudinal Cohort Study
- ClinicalTrials.gov ID
- NCT05023564
- Acronym / sponsor ID
- PUMCH Dementia Cohort
- Conditions
- Dementia, Dementia, Vascular, Dementia With Lewy Bodies, Dementia, Mixed, Dementia Alzheimers, Dementia Frontal
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 31 Dec 2040 (estimated)
- Study completion
- 31 Dec 2040 (estimated)
- First posted
- 26 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Neurodegenerative dementia diagnosis based on 2011 NIA-AA criteria of Dementia
- Fixed care giver and can follow up regularly
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
Cognitive decline
Time frame: Through study completion,an average of 10-20 years
Use a systematic neuropsychological battery designed by PUMCH
Functional decline
Time frame: Through study completion,an average of 10-20 years
Use Activity of Daily Living Scale（ADL）
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.
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.
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.
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
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
CSF collection for assessing new dementia biomarker
Time frame: Through study completion,an average of 10 years
Use collected CSF to assess new biomarkers.
Serum collection for assessing new dementia biomarker
Time frame: Through study completion,an average of 10 years
Use collected serum to assess new biomarkers.
Urine collection for assessing new dementia biomarker
Time frame: Through study completion,an average of 10 years
Use collected urine to assess new biomarkers.
Skin collection for assessing new dementia biomarker
Time frame: Through study completion,an average of 10 years
Use collected skin for finding new biomarkers.
Biomarker differences of dementia
Time frame: Through study completion,an average of 10 years
The differences of biomarkers in patients with different dementia.
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2022.
- Background: PubMed 29653606Jack CR Jr, Bennett DA, Blennow K, Carrillo MC, Dunn B, Haeberlein SB, Holtzman DM, Jagust W, Jessen F, Karlawish J, Liu E, Molinuevo JL, Montine T, Phelps C, Rankin KP, Rowe CC, Scheltens P, Siemers E, Snyder HM, Sperling R; Contributors. NIA-AA Research Framework: Toward a biological definition of Alzheimer's disease. Alzheimers Dement. 2018 Apr;14(4):535-562. doi: 10.1016/j.jalz.2018.02.018.
- Background: PubMed 27068280Olsson B, Lautner R, Andreasson U, Ohrfelt A, Portelius E, Bjerke M, Holtta M, Rosen C, Olsson C, Strobel G, Wu E, Dakin K, Petzold M, Blennow K, Zetterberg H. CSF and blood biomarkers for the diagnosis of Alzheimer's disease: a systematic review and meta-analysis. Lancet Neurol. 2016 Jun;15(7):673-684. doi: 10.1016/S1474-4422(16)00070-3. Epub 2016 Apr 8.
- Background: PubMed 25030513Norton S, Matthews FE, Barnes DE, Yaffe K, Brayne C. Potential for primary prevention of Alzheimer's disease: an analysis of population-based data. Lancet Neurol. 2014 Aug;13(8):788-94. doi: 10.1016/S1474-4422(14)70136-X.
- Background: PubMed 11708987McKhann GM, Albert MS, Grossman M, Miller B, Dickson D, Trojanowski JQ; Work Group on Frontotemporal Dementia and Pick's Disease. Clinical and pathological diagnosis of frontotemporal dementia: report of the Work Group on Frontotemporal Dementia and Pick's Disease. Arch Neurol. 2001 Nov;58(11):1803-9. doi: 10.1001/archneur.58.11.1803.
- Background: PubMed 29055814Rosenberg A, Ngandu T, Rusanen M, Antikainen R, Backman L, Havulinna S, Hanninen T, Laatikainen T, Lehtisalo J, Levalahti E, Lindstrom J, Paajanen T, Peltonen M, Soininen H, Stigsdotter-Neely A, Strandberg T, Tuomilehto J, Solomon A, Kivipelto M. Multidomain lifestyle intervention benefits a large elderly population at risk for cognitive decline and dementia regardless of baseline characteristics: The FINGER trial. Alzheimers Dement. 2018 Mar;14(3):263-270. doi: 10.1016/j.jalz.2017.09.006. Epub 2017 Oct 19.
- Derived from this study: PubMed 39738784Yang X, Wu M, Liang M, Zhang H, Li B, Mao C, Dong L, Wang Y, Xing H, Ren C, Huang Z, Wen Q, Ge Q, Yu Z, Feng F, Gao J, Huo L. Ultra-fast [18F]florbetapir PET imaging using the uMI Panorama PET/CT system. EJNMMI Phys. 2024 Dec 30;11(1):107. doi: 10.1186/s40658-024-00712-5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jing Gao, Doctor contact
Chenhui Mao, Doctor principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia and Dementia, Vascular, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chenhui Mao, Doctor (+86018611895308, maochenhui@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of dementia (time frame: Through study completion,an average of 10-20 years). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05023564, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2022.