DementiaRJNB-ADNCT05623124
Ruijin Neurobank of Alzheimer's Disease and Dementia
An observational study of Dementia, run by Ruijin Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 50 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Dementia
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 22 Nov 2021to 1 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The population consists of Alzheimer's disease, mild cognitive impairment, and cognitively normal participants.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200002
Binyin Li, Dr, 86-13681884221, libinyin@126.com
Xiaomeng Xu, Dr, 86-021-64454473, xuxiaomeng@163.com
About this study
Official title: Neurovascular Coupling and Digital Biomarkers in Alzheimer's Disease
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.
Read the 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.
- Conditions
- Dementia
- Being tested
- No intervention
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Dementia | Participants have cognitive impairment and difficulty in daily activity. Receives: Other: No intervention | |
| Mild cognitive impairment | Participants have cognitive impairment, but no difficulty in daily activity. Receives: Other: No intervention | |
| cognitively normal | Participants do not have cognitive impairment. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
MMSE
Mini-mental state examination
Measured: once a year
Clock drawing test
Clock drawing test
Measured: once a year
Complex figure test
Rey-Osterich complex figure test
Measured: once a year
AVLT
Auditory verbal learning test
Measured: once a year
SDT
Symbol-digit test
Measured: once a year
TMT
Trail making test
Measured: once a year
Naming test
Boston naming test
Measured: once a year
Fluency
Language fluency test
Measured: once a year
Secondary outcomes (5)
Neuroimage markers from MRI
Annual changes of volumes of brain
Measured: once a year
Neuroimage functional markers from fMRI
Annual changes of hippocampus related neural connectivity.
Measured: once a year
Beta-amyloid
Annual changes of beta-amyloid in the brain
Measured: once a year
Tau
Annual changes of tau in the brain
Measured: once a year
SV2A
Annual changes of synaptic vesicle 2A in the brain
Measured: once a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2022
- Study start22 Nov 2021
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05623124
- Sponsor's protocol ID
- RJNeuroBank-Dementia
- Acronym
- RJNB-AD
- Status last verified
- Oct 2024
- First submitted
- 23 Oct 2022
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: There is not yet a plan to make IPD available to other researchers
Publications
Zheng Y, Kang L, Yang X, Zhou R, Chen H, Wang W, Xu X, Xu W, Liu J, Li B, Deng Y. Stage-dependent relationship between sleep duration and cortical tau deposition in cognitively impaired individuals: A cross-sectional study. J Alzheimers Dis. 2026 Jul 1:13872877261462419. doi: 10.1177/13872877261462419. Online ahead of print.
PubMed 42383821Xu X, Yang X, Zhang J, Wang Y, Selim M, Zheng Y, Shen R, Sun L, Huang Q, Wang W, Xu W, Guan Y, Liu J, Deng Y, Xie F, Li B; Alzheimer's Disease Neuroimaging Initiative (ADNI). Choroid plexus free-water correlates with glymphatic function in Alzheimer's disease. Alzheimers Dement. 2025 May;21(5):e70239. doi: 10.1002/alz.70239.
PubMed 40394891
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurovascular Coupling and Digital Biomarkers in Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT05623124
- Acronym / sponsor ID
- RJNB-AD / RJNeuroBank-Dementia
- Conditions
- Dementia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 22 Nov 2021 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 21 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dementia | – | Other: No interventionParticipants have cognitive impairment and difficulty in daily activity. |
| Mild cognitive impairment | – | Other: No interventionParticipants have cognitive impairment, but no difficulty in daily activity. |
| cognitively normal | – | Other: No interventionParticipants do not have cognitive impairment. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The population consists of Alzheimer's disease, mild cognitive impairment, and cognitively normal participants.
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Dementia, Mild cognitive impairment, cognitively normal |
Primary outcome
MMSE
Time frame: once a year
Mini-mental state examination
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
Naming test
Time frame: once a year
Boston naming test
Fluency
Time frame: once a year
Language fluency test
5 secondary outcomes
Neuroimage markers from MRI
Time frame: once a year
Neuroimage functional markers from fMRI
Time frame: once a year
Beta-amyloid
Time frame: once a year
Tau
Time frame: once a year
SV2A
Time frame: once a year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Derived from this study: PubMed 42383821Zheng Y, Kang L, Yang X, Zhou R, Chen H, Wang W, Xu X, Xu W, Liu J, Li B, Deng Y. Stage-dependent relationship between sleep duration and cortical tau deposition in cognitively impaired individuals: A cross-sectional study. J Alzheimers Dis. 2026 Jul 1:13872877261462419. doi: 10.1177/13872877261462419. Online ahead of print.
- Derived from this study: PubMed 40394891Xu X, Yang X, Zhang J, Wang Y, Selim M, Zheng Y, Shen R, Sun L, Huang Q, Wang W, Xu W, Guan Y, Liu J, Deng Y, Xie F, Li B; Alzheimer's Disease Neuroimaging Initiative (ADNI). Choroid plexus free-water correlates with glymphatic function in Alzheimer's disease. Alzheimers Dement. 2025 May;21(5):e70239. doi: 10.1002/alz.70239.
- Individual participant dataSharing planned: Undecided. There is not yet a plan to make IPD available to other researchers
Related trials for Dementia
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MMSE (time frame: once a year). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05623124, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024.