- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06442852
Study on the Relationship Between Peripheral Blood miRNA and Risk and Severity of Alzheimer's Disease
May 30, 2024 updated by: Jiajie Chen
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.
Study Overview
Study Type
Observational
Enrollment (Estimated)
500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jiajie Chen
- Phone Number: 0086-15927561646
- Email: 1005843466@qq.com
Study Locations
-
-
Hubei
-
Wuhan, Hubei, China, 430000
- Recruiting
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
-
Contact:
- Jiajie Chen
- Phone Number: 0086-15927561646
- Email: 1005843466@qq.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Alzheimer's patients or healthy volunteers at Tongji Hospital in Wuhan
Description
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:
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Alzheimer's disease patients
Alzheimer's patients who meet the inclusion criteria and sign an informed consent form
|
The observed exposure factor was the expression level of synaptic associated mirna in the serum of patients with Alzheimer's disease and healthy volunteers
|
Healthy control
Healthy volunteers who meet the inclusion criteria and sign informed consent
|
The observed exposure factor was the expression level of synaptic associated mirna in the serum of patients with Alzheimer's disease and healthy volunteers
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
miR-135a
Time Frame: December 2024
|
synaptic associated miRNA
|
December 2024
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kai Zheng, Tongji Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 3, 2021
Primary Completion (Estimated)
December 30, 2026
Study Completion (Estimated)
December 30, 2026
Study Registration Dates
First Submitted
May 30, 2024
First Submitted That Met QC Criteria
May 30, 2024
First Posted (Estimated)
June 4, 2024
Study Record Updates
Last Update Posted (Estimated)
June 4, 2024
Last Update Submitted That Met QC Criteria
May 30, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TJ-IRB20210116
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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