Alzheimer DiseaseNCT07353502
miR-342-5p/AnkG Pathway in Early AD Synaptic Dysfunction
A study testing Collect peripheral blood, and if the patient consents, also collect cerebrospinal fluid. in people with Alzheimer Disease and Biomarker in Early Diagnosis, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial summary
Alzheimer's disease is the most common memory loss disease among the elderly. This disease affects the patient's memory, language, attention, and behavioral abilities. Current research has found that in the early stages of the disease, synaptic connections between brain nerve cells become abnormal, but the specific… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Biomarker in Early Diagnosis
- What is being tested?
- Collect peripheral blood, and if the patient consents, also collect cerebrospinal fluid.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2025to 10 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Meet the diagnostic criteria for "probable AD dementia" established by the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA)
- MMSE score between 0-23 points, Clinical Dementia Rating (CDR) score ≥0.5 points, Hachinski Ischemic Score <4 points
- Brain MRI showing bilateral temporal lobe and hippocampal atrophy
- Age ≥50 years
- Healthy subjects with age matched to the AD group
- Normal cognitive function and good activities of daily living
- No dementia patients among first-degree relatives
- Negative brain MRI and neurological examination
Who cannot join
- Dementia or cognitive impairment caused by other diseases
- History of substance abuse
- Progressive primary aphasia
- Previous traumatic brain injury
- Patients with comorbid depression, schizophrenia, or severe diseases of the cardiovascular, hepatic, renal, or hematological systems
- Impaired consciousness and inability to cooperate
- Other conditions unsuitable for inclusion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Yiwu, Zhejiang, 322000
xuhua xu
About this study
Official title: Effects of miR-342-5p/AnkG Pathway-Mediated Axon Initial Segment Filtering Injury on Early Synaptic Dysfunction in Alzheimer's Disease and Its Clinical Applications
Alzheimer's disease is the most common memory loss disease among the elderly. This disease affects the patient's memory, language, attention, and behavioral abilities. Current research has found that in the early stages of the disease, synaptic connections between brain nerve cells become abnormal, but the specific cause is still unclear. Investigators' previous research discovered that in the brains of diseased mice, certain special substances (the miR 342 5p/AnkG-mediated pathway) might be related to this abnormality, and these substances can be detected in both blood and cerebrospinal fluid. Therefore, investigators want to further explore the specific mechanisms of abnormal nerve cell connections, seek biomarkers for early detection of the disease, and provide new ideas for early diagnosis in the future.
- Conditions
- Alzheimer Disease, Biomarker in Early Diagnosis
- Being tested
- Collect peripheral blood, and if the patient consents, also collect cerebrospinal fluid.
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collect peripheral blood, and if the patient consents, also collect cerebrospinal fluid.Other
Collect peripheral blood, and if the patient consents, also collect cerebrospinal fluid.
| Study group | Role | What they receive |
|---|---|---|
| AD Group | Experimental | Alzheimer's disease patients, collect peripheral blood, and if the patient agrees, also collect cerebrospinal fluid. Receives: Other: Collect peripheral blood, and if the patient consents, also collect cerebrospinal fluid. |
| Healthy control group | Other | Healthy control, collect peripheral blood, and if the patient agrees, also collect cerebrospinal fluid. Receives: Other: Collect peripheral blood, and if the patient consents, also collect cerebrospinal fluid. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between miR-342-5p/AnkG Pathway and Synaptic Proteins
Quantitative Reverse Transcription-Polymerase Chain Reaction (QT-PCR) detection of microRNA-342-5p (miR-342-5p), Cytometric Bead Array (CBA) method detection of Ankyrin-G (AnkG), and Electrochemiluminescence (ECL) technology detection of neurogranin. Then analyze the correlation between miR-342-5p/AnkG and the synaptic protein neurogranin
Measured: Within 12 weeks after enrollment
Secondary outcomes (1)
The correlation between miR-342-5p/AnkG pathway and cognitive function and brain atrophy
miR-342-5p was detected by qRT-PCR, AnkG was measured by CBA method, cognitive function was evaluated using neuropsychological scales, and hippocampal atrophy was assessed by structural MRI.Then analyze the correlation between miR-342-5p/AnkG and cognitive function and hippocampal atrophy
Measured: Within 12 weeks after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start20 Jun 2025
- Primary completion10 Mar 2026 (estimated)
- Study completion10 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07353502
- Sponsor's protocol ID
- KY-2025-070
- Status last verified
- Jan 2026
- First submitted
- 17 Sep 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Share after the paper is published, on the platform determined by the journal.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of miR-342-5p/AnkG Pathway-Mediated Axon Initial Segment Filtering Injury on Early Synaptic Dysfunction in Alzheimer's Disease and Its Clinical Applications
- ClinicalTrials.gov ID
- NCT07353502
- Acronym / sponsor ID
- KY-2025-070
- Conditions
- Alzheimer Disease, Biomarker in Early Diagnosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 20 Jun 2025 (actual)
- Primary completion
- 10 Mar 2026 (estimated)
- Study completion
- 10 Mar 2026 (estimated)
- First posted
- 20 Jan 2026 (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.
Alzheimer's disease is the most common memory loss disease among the elderly. This disease affects the patient's memory, language, attention, and behavioral abilities. Current research has found that in the early stages of the disease, synaptic connections between brain nerve cells become abnormal, but the specific cause is still unclear. Investigators' previous research discovered that in the brains of diseased mice, certain special substances (the miR 342 5p/AnkG-mediated pathway) might be related to this abnormality, and these substances can be detected in both blood and cerebrospinal fluid. Therefore, investigators want to further explore the specific mechanisms of abnormal nerve cell connections, seek biomarkers for early detection of the disease, and provide new ideas for early diagnosis in the future.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AD Group | Experimental | Other: Collect peripheral blood, and if the patient consents, also collect cerebrospinal fluid.Alzheimer's disease patients, collect peripheral blood, and if the patient agrees, also collect cerebrospinal fluid. |
| Healthy control group | Other | Other: Collect peripheral blood, and if the patient consents, also collect cerebrospinal fluid.Healthy control, collect peripheral blood, and if the patient agrees, also collect cerebrospinal fluid. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Meet the diagnostic criteria for "probable AD dementia" established by the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA)
- MMSE score between 0-23 points, Clinical Dementia Rating (CDR) score ≥0.5 points, Hachinski Ischemic Score <4 points
- Brain MRI showing bilateral temporal lobe and hippocampal atrophy
- Age ≥50 years
- Healthy subjects with age matched to the AD group
Key exclusion criteria (7 listed)
- Dementia or cognitive impairment caused by other diseases
- History of substance abuse
- Progressive primary aphasia
- Previous traumatic brain injury
- Patients with comorbid depression, schizophrenia, or severe diseases of the cardiovascular, hepatic, renal, or hematological systems
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 |
|---|---|---|
| Collect peripheral blood, and if the patient consents, also collect cerebrospinal fluid.Collect peripheral blood, and if the patient consents, also collect cerebrospinal fluid. | Other | AD Group, Healthy control group |
Primary outcome
Correlation between miR-342-5p/AnkG Pathway and Synaptic Proteins
Time frame: Within 12 weeks after enrollment
Quantitative Reverse Transcription-Polymerase Chain Reaction (QT-PCR) detection of microRNA-342-5p (miR-342-5p), Cytometric Bead Array (CBA) method detection of Ankyrin-G (AnkG), and Electrochemiluminescence (ECL) technology detection of neurogranin. Then analyze the correlation between miR-342-5p/AnkG and the synaptic protein neurogranin
1 secondary outcome
The correlation between miR-342-5p/AnkG pathway and cognitive function and brain atrophy
Time frame: Within 12 weeks after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Individual participant dataSharing planned: Yes. Share after the paper is published, on the platform determined by the journal.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collect peripheral blood, and if the patient consents, also collect cerebrospinal fluid. in people with Alzheimer Disease and Biomarker in Early Diagnosis, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine 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 8 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 20 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xu-hua Xu (+8613705790560, fupinglangying@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between miR-342-5p/AnkG Pathway and Synaptic Proteins (time frame: Within 12 weeks after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jan 2026.