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NCT Number: NCT07353502

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

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.

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Key information

Conditions

Alzheimer Disease Biomarker in Early Diagnosis Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Yiwu, Zhejiang, 322000, China

Location status: Recruiting

Location contact

xuhua xu

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Inclusion criteria

for AD group:

  • 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

Inclusion criteria

for control group:

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

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

    Time frame: Within 12 weeks after enrollment

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Xu-hua Xu

CONTACT

[email protected]

+8613705790560

Sponsors and collaborators

Lead sponsor

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 20, 2026
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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