Clinical trial NCT05623124: Ruijin Neurobank of Alzheimer's Disease and Dementia
Official title: Neurovascular Coupling and Digital Biomarkers in Alzheimer's Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dementia
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2022-11-21
Enrollment: 400
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population consists of Alzheimer's disease, mild cognitive impairment, and cognitively normal participants.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: MMSE
timeFrame: once a year
measure: Clock drawing test
timeFrame: once a year
measure: Complex figure test
timeFrame: once a year
measure: AVLT
timeFrame: once a year
measure: SDT
timeFrame: once a year
measure: TMT
timeFrame: once a year
measure: Naming test
timeFrame: once a year
measure: Fluency
timeFrame: once a year
Secondary outcomes:
measure: Neuroimage markers from MRI
timeFrame: once a year
measure: Neuroimage functional markers from fMRI
timeFrame: once a year
measure: Beta-amyloid
timeFrame: once a year
measure: Tau
timeFrame: once a year
measure: SV2A
timeFrame: once a year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine
state: Shanghai
Study officials:
References: