PUMCH Dementia Longitudinal Cohort Study

NCT05023564 | Recruiting

• 1 other identifier: PUMCH Dementia Cohort
• Study Type: observational
• Target: 20,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (18)

• 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

• 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

• 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

• Cognitive decline

  Use a systematic neuropsychological battery designed by PUMCH

  Through study completion,an average of 10-20 years

• Functional decline

  Use Activity of Daily Living Scale（ADL）

  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.

  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.

  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.

  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

  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

  Through study completion,an average of 10 years

• CSF collection for assessing new dementia biomarker

  Use collected CSF to assess new biomarkers.

  Through study completion,an average of 10 years

• Serum collection for assessing new dementia biomarker

  Use collected serum to assess new biomarkers.

  Through study completion,an average of 10 years

• Urine collection for assessing new dementia biomarker

  Use collected urine to assess new biomarkers.

  Through study completion,an average of 10 years

• Skin collection for assessing new dementia biomarker

  Use collected skin for finding new biomarkers.

  Through study completion,an average of 10 years

• Biomarker differences of dementia

  The differences of biomarkers in patients with different dementia.

  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

  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

  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

  Through study completion,an average of 10 years

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• Neurodegenerative dementia diagnosis based on 2011 NIA-AA criteria of Dementia
• Fixed care giver and can follow up regularly

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

RECRUITING

Related Publications (6)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 29055814 BACKGROUND

• 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 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

blood, CSF,urine,skin tissue, brain tissue

MeSH Terms

Conditions

Dementia; Dementia, Vascular; Lewy Body Disease; Mixed Dementias; Alzheimer Disease; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Cerebrovascular Disorders; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Tauopathies; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Chenhui Mao, Doctor

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chenhui Mao, Doctor

CONTACT

+86018611895308; maochenhui@pumch.cn

Jing Gao, Doctor

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2021
• First Posted: August 26, 2021
• Study Start: December 1, 2020
• Primary Completion (Estimated): December 31, 2040
• Study Completion (Estimated): December 31, 2040
• Last Updated: September 13, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)