Amyloid-beta PET Imaging With 18F-92 in Alzheimer's Disease

Study Overview
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Brief Summary
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Alzheimer's disease is a neurodegenerative disease. Numerous studies have reported that β-amyloid (Aβ) is an important marker for the diagnosis of AD. 18F-92 molecular probe is a novel molecularly targeted imaging agent, which can rapidly penetrate the blood-brain barrier and has high affinity and selectivity for Aβ protein. In this study, 18F-92 PET/CT was used to monitor the regional distribution and the degree of deposition in patients with Alzheimer's disease, and compared with clinical symptoms (neuropsychometry) to evaluate its application value in the diagnosis of AD.

Detailed Description
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Healthy volunteers as well as patients meeting Alzheimer's criteria will be recruited for this study. We will use PET/CT imaging technology to scan each participant's whole body or head and collect image data for analysis to evaluate the distribution and metabolism of 18F-92 in the subject's body. Time from drug injection to scan completion is approximately 1 hour.

Official Title
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Amyloid-beta PET Imaging With 18F-92 in Alzheimer's Disease

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Drug: 18F-92


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients or their families complain of significant memory impairment; Objective memory impairment (e.g., tests of article identification, recall, delayed memory); Meets Alzheimer's criteria for DSMIV and NINCDS-ADRDA; Be able to obtain complete diagnosis and treatment records and be able to carry out long-term follow-up; Signed written consent. Exclusion Criteria: Nervous system diseases: including brain tumors, craniocerebral trauma, multiple sclerosis, epilepsy, etc.; Psychiatric disorders: including anxiety disorder, affective disorder, severe psychosis, or drug-induced psychosis; Pregnancy or lactation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 18F-92, PET/CT<br>PET/CT perform after injecting 18F-92 | Drug: 18F-92<br>* Intravenous injection of one dose of 0.10mCi/kg(±5%) 18F-92. Each subject receive a single intravenous injection of 18F-92, and undergo PET/CT imaging within the specificed time.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| standardized uptake value ratio (SUVR) | the ratio of radioactivity in a cerebral region to that in the cerebellum as a reference | From right after tracer injection to 2-hours post-injection | 
| Aβ42 in CSF | Aβ42 (amyloid beta isoform 42) is significantly lower in the cerebrospinal fluid of patients with Alzheimer's disease and is one of the biomarkers used clinically to diagnose Alzheimer's disease | Within 2 hours prior to tracer injection | 
| t-tau in CSF | t-tau (total tau) is significantly increased in the cerebrospinal fluid of patients with Alzheimer's disease and is one of the biomarkers used clinically to diagnose Alzheimer's disease | Within 2 hours prior to tracer injection | 
| p-tau in CSF | p-tau (tau phosphorylated at Thr-181) is significantly increased in the cerebrospinal fluid of patients with Alzheimer's disease and is one of the biomarkers used clinically to diagnose Alzheimer's disease | Within 2 hours prior to tracer injection | 
| MMSE (Mini-mental State Examination) | The commonly used neuropsychological evaluation scale in clinical practice can comprehensively reflect the intellectual status and the degree of cognitive decline of the subjects. 30 points total, lower scores represent worse cognitive function, normal: 27-30 points; cognitive dysfunction: < 27; mild: 21-26; moderate: 10-20; severe: 0-9 | Within 2 hours prior to tracer injection | 
| MoCA (Montreal Cognitive Assessment) | A scale used clinically for cognitive function screening, with a full score of 30, ≥ 27 being normal, 18-26 being mild cognitive impairment, 10-17 being moderate, and less than 10 being severe | Within 2 hours prior to tracer injection |