Alzheimer DiseaseNCT05518409
Immunohistochemical Study of Neurodegenerative Diseases
A study testing Detection of cytof in peripheral PBMC and Donepezil for patients with AD and DLB in people with Alzheimer Disease and Lewy Body Disease, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
The subject uses cytof to analyze PBMC of sporadic AD and DLB, which is used to reveal the differences in immune characteristics of the two diseases at the single-cell level, build immune models for specific diseases, and define these two neurodegenerative diseases with high precision from the level of molecular… Read more about this study
- Who is it for?
- Ages 55 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Lewy Body Disease, Neurodegenerative Diseases
- What is being tested?
- Detection of cytof in peripheral PBMC and Donepezil for patients with AD and DLB
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2022to 30 Dec 2023
- Phase
- Interventional
- 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 55 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- AD inclusion criteria:
- a.Clinical diagnosis of Alzheimer's Disease
- DLB inclusion criteria:
- Clinical diagnosis of Dementia with Lewy bodies
Who cannot join
- Infectious diseases
- autoimmune disease
- heart failure
- chronic obstructive pulmonary disease (COPD)
- cancer
- renal failure
Show all 11Show fewer
- recently major surgery
- alcohol and / or drug abuse
- disturbance of consciousness
- clinical diagnosis of major depression disorder
- clinical diagnosis of Anxiety disorder
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Psychiatry, First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310000
Hu ShaoHua, 13957162903, dorhushaohua@zju.edu.cn
About this study
Official title: Immunohistochemical Study of Peripheral Blood Mononuclear Cells in Sporadic Alzheimer's Disease and Dementia With Lewy Body
The subject uses cytof to analyze PBMC of sporadic AD and DLB, which is used to reveal the differences in immune characteristics of the two diseases at the single-cell level, build immune models for specific diseases, and define these two neurodegenerative diseases with high precision from the level of molecular immunity. To provide basis for further study of the immunohistochemical differences between the two diseases, and provide objective support for clinical diagnosis and differential diagnosis.
- Being tested
- Detection of cytof in peripheral PBMC, Donepezil for patients with AD and DLB
- Medical subject headings
- Alzheimer Disease, Lewy Body Disease, Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detection of cytof in peripheral PBMCBiological
Each subject needs to take 5ml of peripheral venous blood to extract PBMC cells, and then conduct cytof detection. This is a mass spectrometry flow cytometry method based on single cell level. It has the ability to analyze all immune cells with high resolution.
Donepezil for patients with AD and DLBDrug
The subjects in AD and DLB groups were given donepezil at an initial dose of 5mg and then increased to 10mg one month later. Lasting for 1 year.
| Study group | Role | What they receive |
|---|---|---|
| AD group | Experimental | 20 subjects who met the diagnostic criteria and exclusion criteria of AD were included in the discovery cohort. Receives: Biological: Detection of cytof in peripheral PBMC; Drug: Donepezil for patients with AD and DLB |
| DLB group | Experimental | Of the 30 subjects who met the DLB diagnostic criteria and exclusion criteria, 20 were included in the discovery cohort and 10 in the validation cohort. Receives: Biological: Detection of cytof in peripheral PBMC; Drug: Donepezil for patients with AD and DLB |
| Healthy control group | Experimental | Among the 30 subjects who met the diagnostic and exclusion criteria of the healthy control group, 20 were included in the discovery cohort and 10 in the validation cohort. Receives: Biological: Detection of cytof in peripheral PBMC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunerepertorie
The immune cells were drawn into immunoreceptor by mass cytometry (cytof) technology. Immunerepertorie is used for the classification of immune cells. According to the proportion of various immune cell subtypes and biomarkers in all cells, it is used to find the difference between immune cell subtypes and biomarkers in different diseases. Scoring frame: 0-1. The higher the score, the greater the proportion of this subtype or biomarker.
Measured: 1 year
immunological Elastic-Net (iEN) model
The immunological Elastic-Net (iEN), which incorporates immunological knowledge directly into the predictive models. The ROC curve output by the model is plotted with specificity as the abscissa and sensitivity as the ordinate, and the AUC (area under the curve) value is calculated. The AUC value was used to evaluate the authenticity of the IEN model. Score frame: 0.5-1. A higher value indicates that the model is closer to the real situation.
Measured: 1 year
Secondary outcomes (1)
Mini-mental State Examination（MMSE）
MMSE was used to evaluate the degree of intellectual status and cognitive impairment. Score frame: 0 ~ 30. The lower the score, the more severe the cognitive impairment.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start1 Apr 2022
- Primary completion1 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hu ShaoHua, First Affiliated Hospital of Zhejiang University
- Investigators
- Li YouMing, Study chair, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05518409
- Sponsor's protocol ID
- IIT20220213B-R1
- Status last verified
- Sep 2023
- First submitted
- 9 Aug 2022
- Last updated
- 14 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Qiu C, Zhang D, Wang M, Mei X, Chen W, Yu H, Yin W, Peng G, Hu S. Peripheral Single-Cell Immune Characteristics Contribute to the Diagnosis of Alzheimer's Disease and Dementia With Lewy Bodies. CNS Neurosci Ther. 2025 Jan;31(1):e70204. doi: 10.1111/cns.70204.
PubMed 39754303
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunohistochemical Study of Peripheral Blood Mononuclear Cells in Sporadic Alzheimer's Disease and Dementia With Lewy Body
- ClinicalTrials.gov ID
- NCT05518409
- Acronym / sponsor ID
- IIT20220213B-R1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 26 Aug 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 subject uses cytof to analyze PBMC of sporadic AD and DLB, which is used to reveal the differences in immune characteristics of the two diseases at the single-cell level, build immune models for specific diseases, and define these two neurodegenerative diseases with high precision from the level of molecular immunity. To provide basis for further study of the immunohistochemical differences between the two diseases, and provide objective support for clinical diagnosis and differential diagnosis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AD group | Experimental | Biological: Detection of cytof in peripheral PBMC, Drug: Donepezil for patients with AD and DLB20 subjects who met the diagnostic criteria and exclusion criteria of AD were included in the discovery cohort. |
| DLB group | Experimental | Biological: Detection of cytof in peripheral PBMC, Drug: Donepezil for patients with AD and DLBOf the 30 subjects who met the DLB diagnostic criteria and exclusion criteria, 20 were included in the discovery cohort and 10 in the validation cohort. |
| Healthy control group | Experimental | Biological: Detection of cytof in peripheral PBMCAmong the 30 subjects who met the diagnostic and exclusion criteria of the healthy control group, 20 were included in the discovery cohort and 10 in the validation cohort. |
Who may qualify
- Ages
- 55 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- AD inclusion criteria:
- a.Clinical diagnosis of Alzheimer's Disease
- DLB inclusion criteria:
Key exclusion criteria (11 listed)
- Infectious diseases
- autoimmune disease
- heart failure
- chronic obstructive pulmonary disease (COPD)
- cancer
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 |
|---|---|---|
| Detection of cytof in peripheral PBMCEach subject needs to take 5ml of peripheral venous blood to extract PBMC cells, and then conduct cytof detection. This is a mass spectrometry flow cytometry method based on single cell level. It has the ability to analyze all immune cells with high resolution. | Biological | AD group, DLB group, Healthy control group |
| Donepezil for patients with AD and DLBThe subjects in AD and DLB groups were given donepezil at an initial dose of 5mg and then increased to 10mg one month later. Lasting for 1 year. | Drug | AD group, DLB group |
Primary outcome
Immunerepertorie
Time frame: 1 year
The immune cells were drawn into immunoreceptor by mass cytometry (cytof) technology. Immunerepertorie is used for the classification of immune cells. According to the proportion of various immune cell subtypes and biomarkers in all cells, it is used to find the difference between immune cell subtypes and biomarkers in different diseases. Scoring frame: 0-1. The higher the score, the greater the proportion of this subtype or biomarker.
immunological Elastic-Net (iEN) model
Time frame: 1 year
The immunological Elastic-Net (iEN), which incorporates immunological knowledge directly into the predictive models. The ROC curve output by the model is plotted with specificity as the abscissa and sensitivity as the ordinate, and the AUC (area under the curve) value is calculated. The AUC value was used to evaluate the authenticity of the IEN model. Score frame: 0.5-1. A higher value indicates that the model is closer to the real situation.
1 secondary outcome
Mini-mental State Examination（MMSE）
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
- Derived from this study: PubMed 39754303Qiu C, Zhang D, Wang M, Mei X, Chen W, Yu H, Yin W, Peng G, Hu S. Peripheral Single-Cell Immune Characteristics Contribute to the Diagnosis of Alzheimer's Disease and Dementia With Lewy Bodies. CNS Neurosci Ther. 2025 Jan;31(1):e70204. doi: 10.1111/cns.70204.
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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.
Li YouMing study chair
Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Detection of cytof in peripheral PBMC and Donepezil for patients with AD and DLB in people with Alzheimer Disease and Lewy Body Disease, run by First Affiliated Hospital of Zhejiang University 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 4 inclusion and 11 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 14 Sep 2023. 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?
Contact Hu ShaoHua (086-13957162903, dorhushaohua@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunerepertorie (time frame: 1 year). The study lists 2 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 NCT05518409, which also lists 1 linked publication.
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 14 Sep 2023.