Alzheimer DiseaseNCT06442852
Study on the Relationship Between Peripheral Blood miRNA and Risk and Severity of Alzheimer's Disease
An observational study of Alzheimer Disease and MicroRNAs, run by Jiajie Chen at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, MicroRNAs
- What is being tested?
- exposure
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 3 Apr 2021to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Alzheimer's patients or healthy volunteers at Tongji Hospital in Wuhan
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000
Jiajie Chen, 0086-15927561646, 1005843466@qq.com
About this study
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.
- Conditions
- Alzheimer Disease, MicroRNAs
- Being tested
- exposure
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exposureOther
The observed exposure factor was the expression level of synaptic associated mirna in the serum of patients with Alzheimer's disease and healthy volunteers
| Study group | Role | What they receive |
|---|---|---|
| Alzheimer's disease patients | Alzheimer's patients who meet the inclusion criteria and sign an informed consent form Receives: Other: exposure | |
| Healthy control | Healthy volunteers who meet the inclusion criteria and sign informed consent Receives: Other: exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
miR-135a
synaptic associated miRNA
Measured: December 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start3 Apr 2021
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiajie Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jiajie Chen, Tongji Hospital
- Investigators
- Kai Zheng, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06442852
- Sponsor's protocol ID
- TJ-IRB20210116
- Status last verified
- May 2024
- First submitted
- 30 May 2024
- Last updated
- 4 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Relationship Between Peripheral Blood miRNA and Risk and Severity of Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT06442852
- Acronym / sponsor ID
- TJ-IRB20210116
- Conditions
- Alzheimer Disease, MicroRNAs
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Jiajie ChenUniversity, hospital or other
- Study start
- 3 Apr 2021 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alzheimer's disease patients | – | Other: exposureAlzheimer's patients who meet the inclusion criteria and sign an informed consent form |
| Healthy control | – | Other: exposureHealthy volunteers who meet the inclusion criteria and sign informed consent |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Alzheimer's patients or healthy volunteers at Tongji Hospital in Wuhan
Key inclusion criteria (6 listed)
- Meet the diagnostic criteria of NINCDS-ADRDA for AD
- Clinical Dementia Scale (CDR) score ≥0.5
- No complaints or symptoms of cognitive impairment
- MMSE score is higher than the threshold value
Key exclusion criteria (8 listed)
- Dementia or cognitive impairment due to other diseases
- Combined with delirium
- A history of drug abuse
- Severe deafness, aphasia and other impact scale score
- had an organic brain lesion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exposureThe observed exposure factor was the expression level of synaptic associated mirna in the serum of patients with Alzheimer's disease and healthy volunteers | Other | Alzheimer's disease patients, Healthy control |
Primary outcome
miR-135a
Time frame: December 2024
synaptic associated miRNA
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kai Zheng principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease and MicroRNAs, run by Jiajie Chen at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiajie Chen (0086-15927561646, 1005843466@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
miR-135a (time frame: December 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.