Ruijin Neurobank of Alzheimer's Disease and Dementia

NCT ID: NCT05623124

Last Updated: 2024-11-25

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

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-22

Study Completion Date

2025-10-01

Brief Summary

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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

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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.

Conditions

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Dementia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Dementia

Participants have cognitive impairment and difficulty in daily activity.

No intervention

Intervention Type OTHER

No intervention

Mild cognitive impairment

Participants have cognitive impairment, but no difficulty in daily activity.

No intervention

Intervention Type OTHER

No intervention

cognitively normal

Participants do not have cognitive impairment.

No intervention

Intervention Type OTHER

No intervention

Interventions

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No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Male and female aged 50 to 90 years old;
2. 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);
3. The Hamilton depression rating scale/17 edition (HAMD) total score\<10;
4. The clinical dementia rating (CDR) is 0.5 or above;
5. Neurological examination: no obvious signs;
6. Participants should have a caregiver stable and reliable.
7. 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

1. 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.
2. The history of nervous system diseases, including stroke, optic myelitis, Parkinson's disease, epilepsy, etc.);
3. Psychiatric patients, including schizophrenia or other mental illnesses, bipolar disorder, major depression, or delirium;
4. There are unstable or serious heart, lung, liver, kidney, and hematopoietic system diseases; Poor prognosis because of malignant diseases such as tumors.
5. Vision or hearing problems that lead to poor performance on cognitive tests;
6. Two years history of severe alcoholism, and drug abuse;
7. The researchers believe that the subjects could not complete the study.
8. Contraindication of MRI or PET scanning.
Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ruijin Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Binyin Li, Dr

Role: primary

86-13681884221

Xiaomeng Xu, Dr

Role: backup

86-021-64454473

References

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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.

Reference Type DERIVED
PMID: 40394891 (View on PubMed)

Other Identifiers

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RJNeuroBank-Dementia

Identifier Type: -

Identifier Source: org_study_id

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