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NCT Number: NCT05623124

Ruijin Neurobank of Alzheimer's Disease and Dementia

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.

Recruiting

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Key information

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. MMSE

    Time frame: once a year

    Mini-mental state examination

  2. Clock drawing test

    Time frame: once a year

    Clock drawing test

  3. Complex figure test

    Time frame: once a year

    Rey-Osterich complex figure test

  4. AVLT

    Time frame: once a year

    Auditory verbal learning test

  5. SDT

    Time frame: once a year

    Symbol-digit test

  6. TMT

    Time frame: once a year

    Trail making test

  7. Naming test

    Time frame: once a year

    Boston naming test

  8. Fluency

    Time frame: once a year

    Language fluency test

Secondary outcomes

  1. Neuroimage markers from MRI

    Time frame: once a year

    Annual changes of volumes of brain

  2. Neuroimage functional markers from fMRI

    Time frame: once a year

    Annual changes of hippocampus related neural connectivity.

  3. Beta-amyloid

    Time frame: once a year

    Annual changes of beta-amyloid in the brain

  4. Tau

    Time frame: once a year

    Annual changes of tau in the brain

  5. SV2A

    Time frame: once a year

    Annual changes of synaptic vesicle 2A in the brain

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

Neurovascular Coupling and Digital Biomarkers in Alzheimer's Disease

Acronym: RJNB-AD

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Nov 21, 2022
Registry last updated
Nov 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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