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

NCT07353502 | Recruiting

• 1 other identifier: KY-2025-070
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The correlation between miR-342-5p/AnkG pathway and cognitive function and brain atrophy

  Within 12 weeks after enrollment

Study Arms (2)

AD Group

EXPERIMENTAL

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.

Healthy control group

OTHER

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.

Interventions

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.

AD Group; Healthy control group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Yiwu, Zhejiang, 322000, China

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Xu-hua Xu

CONTACT

+8613705790560; fupinglangying@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: January 20, 2026
• Study Start: June 20, 2025
• Primary Completion: March 10, 2026
• Study Completion: March 10, 2026
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)