Amyloid-beta PET Imaging With 18F-92 in Alzheimer's Disease
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|ClinicalTrials.gov Identifier: NCT04926272|
Recruitment Status : Recruiting
First Posted : June 15, 2021
Last Update Posted : June 15, 2021
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease||Drug: 18F-92||Early Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Amyloid-beta PET Imaging With 18F-92 in Alzheimer's Disease|
|Estimated Study Start Date :||June 2021|
|Estimated Primary Completion Date :||June 2024|
|Estimated Study Completion Date :||December 2024|
Experimental: 18F-92, PET/CT
PET/CT perform after injecting 18F-92
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.
- standardized uptake value ratio (SUVR) [ Time Frame: From right after tracer injection to 2-hours post-injection ]the ratio of radioactivity in a cerebral region to that in the cerebellum as a reference
- Aβ42 in CSF [ Time Frame: Within 2 hours prior to tracer injection ]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
- t-tau in CSF [ Time Frame: Within 2 hours prior to tracer injection ]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
- p-tau in CSF [ Time Frame: Within 2 hours prior to tracer injection ]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
- MMSE (Mini-mental State Examination) [ Time Frame: Within 2 hours prior to tracer injection ]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
- MoCA (Montreal Cognitive Assessment) [ Time Frame: Within 2 hours prior to tracer injection ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04926272
|Contact: Weibing Miao, MDemail@example.com|
|Contact: Shaobo Yao, MDfirstname.lastname@example.org|