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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

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What is being tested

Collect peripheral blood, and if the patient consents, also collect cerebrospinal fluid.

Other
Who is being recruted

Alzheimer Disease
+6

+ Mental Disorders
+ Brain Diseases
Over 50 Years
See all eligibility criteria
How is the trial designed

Diagnostic Study

Interventional
Study Start: June 2025
See protocol details

Summary

Principal SponsorThe Fourth Affiliated Hospital of Zhejiang University School of Medicine
Study ContactXu-hua Xu
Last updated: January 21, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: June 20, 2025Actual date on which the first participant was enrolled.

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.

Official TitleEffects of miR-342-5p/AnkG Pathway-Mediated Axon Initial Segment Filtering Injury on Early Synaptic Dysfunction in Alzheimer's Disease and Its Clinical Applications 
NCT07353502
Principal SponsorThe Fourth Affiliated Hospital of Zhejiang University School of Medicine
Study ContactXu-hua Xu
Last updated: January 21, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
40 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Diagnostic Study
Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.

How participants are assigned to different groups/arms
In this clinical study, participants are assigned to groups based on specific criteria, such as their medical history or a doctor's recommendation. This approach ensures that treatments are given to those who may benefit the most, based on known factors.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 50 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Alzheimer Disease
Mental Disorders
Brain Diseases
Central Nervous System Diseases
Dementia
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Tauopathies
Criteria

Inclusion Criteria: Inclusion criteria for AD group: 1. 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) 2. MMSE score between 0-23 points, Clinical Dementia Rating (CDR) score ≥0.5 points, Hachinski Ischemic Score \<4 points 3. Brain MRI showing bilateral temporal lobe and hippocampal atrophy 4. Age ≥50 years Inclusion criteria for control group: 1. Healthy subjects with age matched to the AD group 2. Normal cognitive function and good activities of daily living 3. No dementia patients among first-degree relatives 4. Negative brain MRI and neurological examination Exclusion Criteria: 1. Dementia or cognitive impairment caused by other diseases 2. History of substance abuse 3. Progressive primary aphasia 4. Previous traumatic brain injury 5. Patients with comorbid depression, schizophrenia, or severe diseases of the cardiovascular, hepatic, renal, or hematological systems 6. Impaired consciousness and inability to cooperate 7. Other conditions unsuitable for inclusion

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Alzheimer's disease patients, collect peripheral blood, and if the patient agrees, also collect cerebrospinal fluid.

Collect peripheral blood, and if the patient consents, also collect cerebrospinal fluid.
Group II
Healthy control, collect peripheral blood, and if the patient agrees, also collect cerebrospinal fluid.

Collect peripheral blood, and if the patient consents, also collect cerebrospinal fluid.
Study Objectives
Primary Objectives

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Recruiting
The Fourth Affiliated Hospital of Zhejiang University School of MedicineYiwu, ChinaSee the location
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One Study Center