Ruijin Neurobank of Alzheimer's Disease and Dementia

NCT05623124 | Recruiting DMC

• 1 other identifier: RJNeuroBank-Dementia
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dementia

Outcome Measures

Primary Outcomes (8)

• MMSE

  Mini-mental state examination

  once a year

• Clock drawing test

  Clock drawing test

  once a year

• Complex figure test

  Rey-Osterich complex figure test

  once a year

• AVLT

  Auditory verbal learning test

  once a year

• SDT

  Symbol-digit test

  once a year

• TMT

  Trail making test

  once a year

• Naming test

  Boston naming test

  once a year

• Fluency

  Language fluency test

  once a year

Secondary Outcomes (5)

• Neuroimage markers from MRI

  once a year

• Neuroimage functional markers from fMRI

  once a year

• Beta-amyloid

  once a year

• Tau

  once a year

• SV2A

  once a year

Study Arms (3)

Dementia

Participants have cognitive impairment and difficulty in daily activity.

Other: No intervention

Mild cognitive impairment

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

Other: No intervention

cognitively normal

Participants do not have cognitive impairment.

Other: No intervention

Interventions

No intervention OTHER

No intervention

Dementia; Mild cognitive impairment; cognitively normal

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population consists of Alzheimer's disease, mild cognitive impairment, and cognitively normal participants.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200002, China

RECRUITING

Related Publications (1)

• 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 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

plasma, serum, and DNA extracted from white blood cell

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

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

Study Record Dates

• First Submitted: October 23, 2022
• First Posted: November 21, 2022
• Study Start: November 22, 2021
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: November 25, 2024

Record last verified: 2024-10

Locations

CN (1)