PUMCH Dementia Longitudinal Cohort Study

Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05023564
• Other study ID #: PUMCH Dementia Cohort
• Status: Recruiting
• Start date: December 1, 2020
• Est. completion date: December 31, 2040

Study information

• Verified date: September 2022
• Source: Peking Union Medical College Hospital
• Contact: Chenhui Mao, Doctor
• Phone: +86018611895308
• Email: maochenhui[@]pumch.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20000
• Est. completion date: December 31, 2040
• Est. primary completion date: December 31, 2040
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia
• Dementia Alzheimers
• Dementia Frontal
• Dementia With Lewy Bodies
• Dementia, Mild
• Dementia, Mixed
• Dementia, Vascular
• Lewy Body Disease

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

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. Review. — View Citation

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. — View Citation

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. Erratum in: Lancet Neurol. 2014 Nov;13(11):1070. — View Citation

Olsson B, Lautner R, Andreasson U, Öhrfelt A, Portelius E, Bjerke M, Hölttä M, Rosén 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. Review. — View Citation

Rosenberg A, Ngandu T, Rusanen M, Antikainen R, Bäckman L, Havulinna S, Hänninen T, Laatikainen T, Lehtisalo J, Levälahti E, Lindström 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of dementia	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
Primary	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	Through study completion,an average of 10 years
Primary	Risk factors for dementia	Collect the risk factors in normal control and analysis the relationship after diagnosis of dementia	Through study completion,an average of 10-20 years
Primary	Cognitive decline	Use a systematic neuropsychological battery designed by PUMCH	Through study completion,an average of 10-20 years
Primary	Functional decline	Use Activity of Daily Living Scale(ADL)	Through study completion,an average of 10-20 years
Primary	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.	Through study completion,an average of 10 years
Primary	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.	Through study completion,an average of 10 years
Primary	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.	Through study completion,an average of 10 years
Primary	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	Through study completion,an average of 10 years
Primary	Tau biomarkers in serum	Concentration ( pg/mL) of tau in serum of patients with dementia and controls	Through study completion,an average of 10 years
Primary	CSF collection for assessing new dementia biomarker	Use collected CSF to assess new biomarkers.	Through study completion,an average of 10 years
Primary	Serum collection for assessing new dementia biomarker	Use collected serum to assess new biomarkers.	Through study completion,an average of 10 years
Primary	Urine collection for assessing new dementia biomarker	Use collected urine to assess new biomarkers.	Through study completion,an average of 10 years
Primary	Skin collection for assessing new dementia biomarker	Use collected skin for finding new biomarkers.	Through study completion,an average of 10 years
Primary	Biomarker differences of dementia	The differences of biomarkers in patients with different dementia.	Through study completion,an average of 10 years
Primary	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	Through study completion,an average of 10 years
Primary	Dementia education and training	Observe the function of education and training in the treatment and care of dementia patients	Through study completion,an average of 10 years
Primary	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	Through study completion,an average of 10 years