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Clinical Trials/NCT05623124
NCT05623124
Recruiting
Not Applicable

Neurovascular Coupling and Digital Biomarkers in Alzheimer's Disease

Ruijin Hospital1 site in 1 country400 target enrollmentNovember 22, 2021
ConditionsDementia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dementia
Sponsor
Ruijin Hospital
Enrollment
400
Locations
1
Primary Endpoint
MMSE
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 22, 2021
End Date
October 1, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

MMSE

Time Frame: once a year

Mini-mental state examination

Naming test

Time Frame: once a year

Boston naming test

Clock drawing test

Time Frame: once a year

Clock drawing test

Complex figure test

Time Frame: once a year

Rey-Osterich complex figure test

AVLT

Time Frame: once a year

Auditory verbal learning test

SDT

Time Frame: once a year

Symbol-digit test

TMT

Time Frame: once a year

Trail making test

Fluency

Time Frame: once a year

Language fluency test

Secondary Outcomes

  • Tau(once a year)
  • Neuroimage markers from MRI(once a year)
  • Neuroimage functional markers from fMRI(once a year)
  • Beta-amyloid(once a year)
  • SV2A(once a year)

Study Sites (1)

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