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Ruijin Neurobank of Alzheimer's Disease and Dementia

Neurovascular Coupling and Digital Biomarkers in Alzheimer's Disease

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05623124
Acronym
RJNB-AD
Enrollment
400
Registered
2022-11-21
Start date
2021-11-22
Completion date
2025-10-01
Last updated
2024-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia

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.

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

OTHERNo intervention

No intervention

Sponsors

Ruijin Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Fluencyonce a yearLanguage fluency test
Complex figure testonce a yearRey-Osterich complex figure test
AVLTonce a yearAuditory verbal learning test
SDTonce a yearSymbol-digit test
TMTonce a yearTrail making test
Naming testonce a yearBoston naming test
MMSEonce a yearMini-mental state examination
Clock drawing testonce a yearClock drawing test

Secondary

MeasureTime frameDescription
Tauonce a yearAnnual changes of tau in the brain
Neuroimage markers from MRIonce a yearAnnual changes of volumes of brain
SV2Aonce a yearAnnual changes of synaptic vesicle 2A in the brain
Neuroimage functional markers from fMRIonce a yearAnnual changes of hippocampus related neural connectivity.
Beta-amyloidonce a yearAnnual changes of beta-amyloid in the brain

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 3, 2026