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Recruiting NCT05023564

PUMCH Dementia Longitudinal Cohort Study

— Observational Dementia Dementia, Vascular Dementia With Lewy Bodies Dementia, Mixed

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Dementia, Dementia, Vascular, Dementia With Lewy Bodies, Dementia, Mixed. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Primary outcome measures

  • The incidence of dementia [Time frame: 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]
  • Risk factors for dementia [Time frame: Through study completion,an average of 10-20 years]
  • Cognitive decline [Time frame: Through study completion,an average of 10-20 years]
  • Functional decline [Time frame: 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]
  • Changes in the Hospital Anxiety and Depression scale (HAD) [Time frame: 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]
  • Tau and Beta-amyloid biomarkers in CSF [Time frame: Through study completion,an average of 10 years]
  • Tau biomarkers in serum [Time frame: Through study completion,an average of 10 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Peking Union Medical College Hospital — Beijing

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. PMID 29653606
  • 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. PMID 27068280
  • 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. PMID 25030513
  • 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. PMID 11708987
  • 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: PMID 29055814
  • 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. PMID 39738784

Identifiers

NCT: NCT05023564 · PUMCH Dementia Cohort

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗