Ruijin Neurobank of Alzheimer's Disease and Dementia

Recruiting

• Conditions: Dementia
• Interventions: Other: No intervention

• Registration Number: NCT05623124
• Lead Sponsor: Ruijin Hospital

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.

Study Timeline

• Study Start: 2021-11-22
• Study First Submitted: 2022-10-23
• Study First Submitted QC: 2022-11-14
• Study First Posted: 2022-11-21
• Status Verified: 2024-10
• Last Update Submitted: 2024-11-21
• Last Update Posted: 2024-11-25
• Primary Completion: 2025-10-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Dementia	No intervention	Participants have cognitive impairment and difficulty in daily activity.
cognitively normal	No intervention	Participants do not have cognitive impairment.
Mild cognitive impairment	No intervention	Participants have cognitive impairment, but no difficulty in daily activity.

Primary Outcome Measures

Name	Time	Method
MMSE	once a year	Mini-mental state examination
Naming test	once a year	Boston naming test
Clock drawing test	once a year	Clock drawing test
Complex figure test	once a year	Rey-Osterich complex figure test
AVLT	once a year	Auditory verbal learning test
SDT	once a year	Symbol-digit test
TMT	once a year	Trail making test
Fluency	once a year	Language fluency test

Secondary Outcome Measures

Name	Time	Method
Neuroimage markers from MRI	once a year	Annual changes of volumes of brain
Tau	once a year	Annual changes of tau in the brain
Neuroimage functional markers from fMRI	once a year	Annual changes of hippocampus related neural connectivity.
Beta-amyloid	once a year	Annual changes of beta-amyloid in the brain
SV2A	once a year	Annual changes of synaptic vesicle 2A in the brain

Trial Locations

Locations (1)

Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China