CClinicalTrials.gg
RecruitingNCT06442852Updated Jun 4, 2024

Study on the Relationship Between Peripheral Blood miRNA and Risk and Severity of Alzheimer's Disease

An observational study in Alzheimer Disease and MicroRNAs, sponsored by Jiajie Chen. Recruiting at 1 site in China. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-04.

Sponsored by Jiajie Chen · Observational

From the registry’s dates

  • Started Apr 2021; still recruiting 5 years 6 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
500
Ages
65 Years and older
Sex
All
01

Study summary

Alzheimer's Disease, AD is a type of neurofibrillary tangles formed by the deposition of beta amyloid proteins within the nervous system cells and excessive phosphorylation of extracellular Tau proteins, NFTs are the main pathological features of central nervous system degeneration, also known as senile dementia. In addition, synaptic plasticity damage and neuroinflammation also play important roles in the progression of AD. Neurosynapses are the sites where neurons interact with each other in terms of function, and are also crucial for neuronal information transmission and communication. Synapses are the fundamental units in the brain, and synaptic activity can stimulate the maturation of mushroom like dendritic spines and form new synapses, enabling synaptic strength to adapt to changes in the internal and external environment, thereby playing an important role in learning and memory. Previous studies have shown that synaptic activity interruption and synaptic loss can already be detected in the AD brain, especially in the early stages. Multiple studies have shown a higher correlation between synaptic disorders characterized by synaptic loss and decreased synaptic activity and cognitive impairment in Alzheimer's disease compared to age-related plaques and neurofibrillary tangles. Therefore, understanding the potential mechanisms of synaptic disorders will contribute to the development of early treatment strategies for AD. MicroRNAs (miRNAs) are a type of small non coding RNA with a length of approximately 22 nucleotides. Their main function is to silence target genes at the post transcriptional level and inhibit the translation process of their proteins. MiRNAs are involved in many physiological processes and pathological pathways, including development, tumorigenesis, and heart disease. Recently, people have also studied the abnormal regulatory role of miRNAs in AD synaptic disorders. Some miRNAs enriched in the brain, such as miR-124, MiR-132 is abnormally expressed in the AD brain, mediating synaptic plasticity damage. However, most of the miRNAs mentioned above are not directly related to synaptic activity, and their regulation of AD synaptic damage is likely to be a broad-spectrum effect. At present, there are 12 miRNAs closely related to synaptic plasticity that have been identified. By detecting changes in miRNAs closely related to synaptic plasticity in peripheral blood of AD patients and healthy volunteers, and exploring their relationship with the severity of AD lesions, it may provide new directions for early diagnosis of AD. The purpose of this study is to: (1) detect the expression levels of miRNAs closely related to synaptic plasticity in the peripheral blood of healthy volunteers and AD patients, and identify the miRNAs with the greatest differences; (2) Analyze the relationship between the expression levels of the aforementioned miRNAs in the peripheral blood of AD patients and the severity of the disease; (3) Analyze the relationship between the expression levels of the aforementioned miRNAs in the peripheral blood of AD patients and the commonly used neuropsychiatric scale scores. We plan to clarify the changes in peripheral blood miRNAs and their relationship with the severity of AD through case-control studies, in order to provide new directions for early diagnosis of AD.

02

Conditions studied

  • Alzheimer Disease
  • MicroRNAs

Browse trials for

03

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's planned enrollment of 500 is above the median of 200 across 751 observational studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

This is the only study on the registry with Jiajie Chen as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Alzheimer's patients or healthy volunteers at Tongji Hospital in Wuhan

Inclusion criteria

Alzheimer's disease patients:

  • Meet the diagnostic criteria of NINCDS-ADRDA for AD
  • Clinical Dementia Scale (CDR) score ≥0.5

Healthy volunteers:

  • No complaints or symptoms of cognitive impairment
  • MMSE score is higher than the threshold value

Exclusion criteria

Exclusion Criteria:

Alzheimer's disease patients:

  • Dementia or cognitive impairment due to other diseases
  • Combined with delirium
  • A history of drug abuse
  • Severe deafness, aphasia and other impact scale score

Healthy volunteers:

  • had an organic brain lesion
  • Suffering from other major physical diseases: such as severe immune diseases
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
500 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Alzheimer's disease patients

    Alzheimer's patients who meet the inclusion criteria and sign an informed consent form

    Other: exposure

  • Healthy control

    Healthy volunteers who meet the inclusion criteria and sign informed consent

    Other: exposure

Interventions

  • Otherexposure

    The observed exposure factor was the expression level of synaptic associated mirna in the serum of patients with Alzheimer's disease and healthy volunteers

06

What researchers measure

Primary outcomes

  1. miR-135a

    synaptic associated miRNA

    Time frame: December 2024

07

Study locations

1 of 1 sites recruiting
  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
    Wuhan, Hubei 430000, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06442852
Lead sponsor
Jiajie Chen
Responsible party
Jiajie Chen (doctor, Tongji Hospital) — Sponsor-investigator
First posted
Jun 4, 2024
Start date
Apr 3, 2021
Primary completion
Dec 30, 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
Jun 4, 2024

Study contacts

Jiajie Chen
Contact
1005843466@qq.com
0086-15927561646
Kai Zheng
principal investigator · Tongji Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion