PUMCH Dementia Longitudinal Cohort Study

NCT ID: NCT05023564

Last Updated: 2022-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

20000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-01

Study Completion Date

2040-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Dementia Dementia, Vascular Dementia With Lewy Bodies Dementia, Mixed Dementia Alzheimers Dementia Frontal Dementia, Mild

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Early onset dementia

Dementia patients with onset age lower than 65y/o

No interventions assigned to this group

Late onset dementia

Dementia patients with onset age between 65y/o and 85y/o

No interventions assigned to this group

Oldest old dementia

Dementia patients with onset age older than 85y/o

No interventions assigned to this group

Cognitive normal control

Normal Aging with normal cognitive function

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chenhui Mao, Doctor

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

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Peking Union Medical College Hospital

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Chenhui Mao, Doctor

Role: CONTACT

+86018611895308

Jing Gao, Doctor

Role: CONTACT

Facility Contacts

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Chenhui Mao, Doctor

Role: primary

Jing Gao, Doctor

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 29653606 (View on PubMed)

Olsson 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.

Reference Type BACKGROUND
PMID: 27068280 (View on PubMed)

Norton 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.

Reference Type BACKGROUND
PMID: 25030513 (View on PubMed)

McKhann 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.

Reference Type BACKGROUND
PMID: 11708987 (View on PubMed)

Rosenberg 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.

Reference Type BACKGROUND
PMID: 29055814 (View on PubMed)

Yang 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.

Reference Type DERIVED
PMID: 39738784 (View on PubMed)

Other Identifiers

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PUMCH Dementia Cohort

Identifier Type: -

Identifier Source: org_study_id

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