miR-342-5p/AnkG Pathway in Early AD Synaptic Dysfunction

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.

Study Overview

• Status: Recruiting
• Conditions: Alzheimer Disease; Biomarker in Early Diagnosis
• Intervention / Treatment: Other: Collect peripheral blood, and if the patient consents, also collect cerebrospinal fluid.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xu-hua Xu; Phone Number: +8613705790560; Email: fupinglangying@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Yiwu, Zhejiang, China, 322000
      • Recruiting
      • The Fourth Affiliated Hospital of Zhejiang University School of Medicine
      • Contact: xuhua xu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AD Group; Alzheimer's disease patients, collect peripheral blood, and if the patient agrees, also collect cerebrospinal fluid.	Other: 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: Healthy control group; Healthy control, collect peripheral blood, and if the patient agrees, also collect cerebrospinal fluid.	Other: Collect peripheral blood, and if the patient consents, also collect cerebrospinal fluid.; Collect peripheral blood, and if the patient consents, also collect cerebrospinal fluid.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Within 12 weeks after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Within 12 weeks after enrollment

Collaborators and Investigators

• Sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2025
• Primary Completion (Estimated): March 10, 2026
• Study Completion (Estimated): March 10, 2026

Study Registration Dates

• First Submitted: September 17, 2025
• First Submitted That Met QC Criteria: January 18, 2026
• First Posted (Actual): January 20, 2026

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 18, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Alzheimer Disease
• Other Study ID Numbers: KY-2025-070

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Share after the paper is published, on the platform determined by the journal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No