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Recruiting NCT05623124

Ruijin Neurobank of Alzheimer's Disease and Dementia

— Observational Dementia

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
The protocol lists: No intervention.
Who it may be relevant to
Registry conditions: Dementia. Basic parameters: 50 years — 90 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 →

Unsure about the terms? Read our patient guide →

Official title

Neurovascular Coupling and Digital Biomarkers in Alzheimer's Disease

Overview

The goal of this observational study is to learn about neuroimage and biomarkers in the Alzheimer's continuum. The main questions it aims to answer are: * How is the neurovascular coupling during AD pathogenesis? * How is the pattern/mapping of alterations in AD biomarkers? Participants will be observed and visit the research center annually to perform multi-modal MRI, PET, neuropsychological tests, and blood tests.

Detailed description

The observational study recruits participants from clinics and communities with cognitive impairment. Healthy volunteers will also be recruited as controls. Longitudinal observation of these participants will help demonstrate AD biomarkers' significance during AD pathogenesis.

The investigators aim to build an aging population cohort covering the AD continuum and explore key biomarkers for AD. All participants will have multi-modal MRI scanning, PET scanning with different tracers, and blood test. With MRI scanning, the investigators are exploring the effect of neurovascular coupling in AD pathogenesis. In addition, the investigators are trying to find patterns/mapping of AD biomarkers with PET and blood tests. Beyond this, more neuroimage markers and digital biomarkers will be tested in the cohort.

Interventions

  • Other No intervention
    No intervention

Primary outcome measures

  • MMSE [Time frame: once a year]
  • Clock drawing test [Time frame: once a year]
  • Complex figure test [Time frame: once a year]
  • AVLT [Time frame: once a year]
  • SDT [Time frame: once a year]
  • TMT [Time frame: once a year]
  • Naming test [Time frame: once a year]
  • Fluency [Time frame: once a year]
Secondary outcome measures (5)
  • Neuroimage markers from MRI [Time frame: once a year]
  • Neuroimage functional markers from fMRI [Time frame: once a year]
  • Beta-amyloid [Time frame: once a year]
  • Tau [Time frame: once a year]
  • SV2A [Time frame: once a year]

Eligibility criteria

Inclusion criteria

  • Male and female aged 50 to 90 years old;
  • In accordance with the diagnostic criteria for "mild cognitive impairment due to Alzheimer's disease" and "Dementia" from the National Institutes of Health National Institute on Aging-Alzheimer's Association (NIA-AA) (2011);
  • The Hamilton depression rating scale/17 edition (HAMD) total score<10;
  • The clinical dementia rating (CDR) is 0.5 or above;
  • Neurological examination: no obvious signs;
  • Participants should have a caregiver stable and reliable.
  • Education: primary school (grade 6) or above. They have the ability to complete tests for cognitive ability and have the ability and time to complete regulation of cognitive training

Exclusion criteria

  • Other causes of cognitive decline: cerebrovascular disease, central nervous system infection, CJD, Huntington's and Parkinson's disease, DLB, traumatic brain dementia, other physical and chemical factors (such as drugs, alcohol, CO), systemic disease (hepatic encephalopathy, pulmonary encephalopathy, etc.), intracranial occupation (a subdural hematoma, brain tumor), the endocrine system disease (thyroid disease, parathyroid disease), and vitamins deficiency or any other causes of dementia.
  • The history of nervous system diseases, including stroke, optic myelitis, Parkinson's disease, epilepsy, etc.);
  • Psychiatric patients, including schizophrenia or other mental illnesses, bipolar disorder, major depression, or delirium;
  • There are unstable or serious heart, lung, liver, kidney, and hematopoietic system diseases; Poor prognosis because of malignant diseases such as tumors.
  • Vision or hearing problems that lead to poor performance on cognitive tests;
  • Two years history of severe alcoholism, and drug abuse;
  • The researchers believe that the subjects could not complete the study.
  • Contraindication of MRI or PET scanning.

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
  • Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine — Shanghai

Publications

  • Zheng Y, Kang L, Yang X, Zhou R, Chen H, Wang W, Xu X, Xu W, Liu J, Li B, Deng Y. Stage-dependent relationship between sleep duration and cortical tau deposition in cognitively impaired individuals: A cross-sectional study. J Alzheimers Dis. 2026 Jul 1:13872877261462419. doi: 10.1177/13872877261462419. Online ahead of print. PMID 42383821
  • Xu X, Yang X, Zhang J, Wang Y, Selim M, Zheng Y, Shen R, Sun L, Huang Q, Wang W, Xu W, Guan Y, Liu J, Deng Y, Xie F, Li B; Alzheimer's Disease Neuroimaging Initiative (ADNI). Choroid plexus free-water correlates with glymphatic function in Alzheimer's disease. Alzheimers Dement. 2025 May;21(5):e70239. doi: 10.1002/alz.70239. PMID 40394891

Identifiers

NCT: NCT05623124 · RJNeuroBank-Dementia

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗