Ruijin Neurobank of Alzheimer's Disease and Dementia

Dementia Clinical Trial

— RJNB-AD  

Official title:

Neurovascular Coupling and Digital Biomarkers in Alzheimer's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05623124
• Other study ID #: RJNeuroBank-Dementia
• Status: Recruiting
• Start date: November 22, 2021
• Est. completion date: October 1, 2025

Study information

• Verified date: October 2022
• Source: Ruijin Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: October 1, 2025
• Est. primary completion date: October 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
China	Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MMSE	Mini-mental state examination	once a year
Primary	Clock drawing test	Clock drawing test	once a year
Primary	Complex figure test	Rey-Osterich complex figure test	once a year
Primary	AVLT	Auditory verbal learning test	once a year
Primary	SDT	Symbol-digit test	once a year
Primary	TMT	Trail making test	once a year
Primary	Naming test	Boston naming test	once a year
Primary	Fluency	Language fluency test	once a year
Secondary	Neuroimage markers from MRI	Annual changes of volumes of brain	once a year
Secondary	Neuroimage functional markers from fMRI	Annual changes of hippocampus related neural connectivity.	once a year
Secondary	Beta-amyloid	Annual changes of beta-amyloid in the brain	once a year
Secondary	Tau	Annual changes of tau in the brain	once a year
Secondary	SV2A	Annual changes of synaptic vesicle 2A in the brain	once a year