NCT06442852 Study on the Relationship Between Peripheral Blood miRNA and Risk and Severity of Alzheimer's Disease
| NCT ID | NCT06442852 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jiajie Chen |
| Condition | Alzheimer Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2021-04-03 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2021-04-03 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Kai Zheng
PRINCIPAL INVESTIGATOR
Tongji Hospital
Frequently Asked Questions
Who can join the NCT06442852 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Alzheimer Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06442852 currently recruiting?
Yes, NCT06442852 is actively recruiting participants. Contact the research team at 1005843466@qq.com for enrollment information.
Where is the NCT06442852 trial being conducted?
This trial is being conducted at Wuhan, China.
Who is sponsoring the NCT06442852 clinical trial?
NCT06442852 is sponsored by Jiajie Chen. The principal investigator is Kai Zheng at Tongji Hospital. The trial plans to enroll 500 participants.
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