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Role and mechanism of FPR2-regulated B-cell activation in early Alzheimer's disease

Role and mechanism of FPR2 regulated B-cell activation in early Alzheimer's disease

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400087917
Enrollment
Unknown
Registered
2024-08-07
Start date
2024-08-20
Completion date
Unknown
Last updated
2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's disease

Interventions

Case group:none
Heathy control group:none

Sponsors

Affiliated Hospital of Zunyi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for healthy individuals:30 healthy participants, including10 participants aged 18-39 years old, 10 participants aged 40-59 years old, and 10 participants aged 60-80 years old. There is no gender restriction. Enrollment criteria for Alzheimer's disease: (1)10 participants 40 years old = age = 59 years old, 10 participants 60 years old = age = 80 years old,; (2) regardless of gender; (3) meeting the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) diagnostic criteria for probable AD (1984); (4) the degree of the disease being mild, the total score of the Mini-mental State Examination (MMSE) total score: 21 = MMSE total score = 26 (21 = MMSE score = 22 for subjects with elementary school education); 5) Hutchinsky Ischemic Scale (HIS) total score = 4; 6) Hamilton Depression Scale/17-item version (HAMD) total score = 10; 7) Memory loss for at least 12 months with a tendency for progressive exacerbation; 8) At the time of screening A cranial MRI scan and oblique coronal hippocampal scan must be performed to support the diagnosis of Alzheimer's disease, with a Medial Temporal Atrophy Visual Rating Scale MTA classification =2; 9) No obvious neurological localization signs; 10) Subjects were elementary school educated and above, and were able to complete the cognitive function assessment and other tests as specified in the protocol; 11) Participated in the study voluntarily, and signed an informed consent form.

Exclusion criteria

Exclusion criteria: Exclusion criteria for healthy individuals: 1) Previously received cell therapy; 2) Previous or existing history of intracranial, subdural, or subarachnoid hemorrhage; 3) Subjects with baseline brain MRI showing more than four (4) cerebral microbleeds (regardless of their anatomical location or diagnostic features as "possible" or "determined") and/or one (1) or more superficial iron deposition areas, and/or evidence of previous major bleeding. MRI must include liquid attenuated inversion recovery (FLAIR) and T2 * weighted gradient echo (GRE) sequences; 4) History of cancer in the past 5 years, excluding local basal cell carcinoma or squamous cell carcinoma; 5) History of epilepsy; 6) Diagnosis of autosomal dominant inherited cerebral artery disease (CADASIL) with subcortical infarction and white matter encephalopathy; 7) History of previous or chronic cancer; 8) Patients with a history of severe cardiovascular and cerebrovascular diseases, severe liver and kidney dysfunction, or any blood related diseases; 9) Pregnant or lactating women; 10) Participated in clinical trials of other drugs (defined as receiving the investigational drug or placebo) within 3 months prior to randomization; 11) Individuals with any history of allergies; 12) History of infection in the past 4 weeks; 13) Patients who have been taking immunosuppressants or hormones for a long time in the past; 14) The researcher determines that the subjects are not suitable to participate in other situations of this clinical trial. Exclusion criteria for Alzheimer's disease individuals: 1)During screening, MRI examination showed significant focal lesions: there were more than 2 infarctions with a diameter greater than 2 cm, and there were infarctions in key areas such as thalamus, hippocampus, entorhinal cortex, paraolfactory cortex, angular gyrus, cortex, and other subcortical gray matter nuclei; Fazekas Scale classification of white matter damage = 3; 2) Previously suffered from neurological disorders (including stroke, optic neuritis, Parkinson's disease, epilepsy, etc.); 3) Psychiatric patients, according to DSM-IV-TR criteria, including schizophrenia or other psychiatric disorders, bipolar disorder, major depression or delirium; 4) Having unstable or severe heart, lung, liver, kidney, or hematopoietic system diseases; 5) There are uncorrectable visual and auditory impairments that prevent the completion of neuropsychological tests and scale assessments; 6) History of infection in the past 4 weeks; 7) Patients who have been taking immunosuppressants or hormones for a long time in the past; 8) History of previous or chronic cancer; 9) The researcher determines that the subjects are not suitable to participate in other situations of this clinical trial.

Design outcomes

Primary

MeasureTime frame
FPR2 expression in B cell;The effect of regulating FPR2 expression on B cell actin remodeling and BCR signaling;

Countries

China

Contacts

Public Contactchang-yin Yu

Affiliated Hospital of Zunyi Medical University

yuchangyin6812@126.com+86 139 8421 9321

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026