miR-342-5p and AnkG pathway in early Alzheimer's synapse changes
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
This study will test whether levels of the miR-342-5p/AnkG pathway in blood or cerebrospinal fluid reflect early synaptic damage in people aged 50 and older with probable Alzheimer's and in healthy age-matched volunteers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | The Fourth Affiliated Hospital of Zhejiang University School of Medicine Academic / other |
| Locations | 1 site (Yiwu, Zhejiang) |
| Trial ID | NCT07353502 on ClinicalTrials.gov |
What this trial studies
Researchers will compare people with probable Alzheimer's dementia to healthy age-matched controls to study changes in the miR-342-5p/AnkG pathway linked to early synaptic dysfunction. Participants will undergo cognitive screening, brain MRI confirmation, blood collection, and optional cerebrospinal fluid collection with consent. The team will measure pathway components in peripheral blood and CSF and correlate those levels with cognitive scores and MRI findings. The goal is to clarify mechanisms of early synaptic abnormality and identify accessible biomarkers for earlier diagnosis.
Who should consider this trial
Good fit: Ideal candidates are adults aged 50 or older who meet NINCDS-ADRDA criteria for probable Alzheimer's dementia (MMSE 0–23, CDR ≥0.5, hippocampal/temporal atrophy on MRI) or healthy age-matched controls with normal cognition and negative MRI.
Not a fit: People whose cognitive impairment is explained by other neurological or psychiatric conditions, prior traumatic brain injury, substance abuse, or severe comorbid illness, and those unwilling to provide blood or CSF samples are unlikely to gain benefit from participation.
Why it matters
Potential benefit: If successful, this work could produce blood- or CSF-based biomarkers that enable earlier detection of Alzheimer's-related synaptic changes and support earlier intervention or trial enrollment.
How similar studies have performed: Previous animal studies and small human investigations of microRNA and AnkG-related biomarkers have shown early promise, but these approaches are not yet validated for routine clinical use.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Yiwu, Zhejiang
- The Fourth Affiliated Hospital of Zhejiang University School of Medicine — Yiwu, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Xu-hua Xu
- Email: fupinglangying@zju.edu.cn
- Phone: +8613705790560
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.