[18F]Florbetazine ([18F]92) for Beta Amyloid PET Imaging in Alzheimer's Disease
NCT ID: NCT06141356
Last Updated: 2023-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
150 participants
OBSERVATIONAL
2023-01-30
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The purpose of the current study is to examine the binding properties of \[18F\]Florbetazine in human subjects and to compare the cortical and white matter binding with \[11C\]PiB or \[18F\]Florbetapir in the same subjects.
Imaging of the brain will be completed in healthy adult normal control participants and participants with cognitive impairment (including probable AD and dementia due to other conditions) to characterize \[18F\]Florbetazine uptake in the brain and its binding properties. \[11C\]PIB or \[18F\]Florbetapir PET imaging along with MRI will be completed in the same participants and the data will be compared with 18F-\[18F\]Florbetazine.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Healthy participants
Drug: \[18F\]Florbetazine (\[18F\]92). A dosage of 10 mCi +/- 20% of Florbetazine will be injected by a PET-certified medical professional followed by 5ml 0.9% sodium chloride (normal saline) flush.
Drug: \[11C\]PIB. A dosage range between 6.0-20.0 mCi of PIB will be injected by a PET-certified medical professional followed by 5ml 0.9% sodium chloride (normal saline) flush.
[18F]Florbetazine ([18F]92)
Participants will receive a single intravenous bolus injection of 10 mCi ± 20% of the investigational radiotracer \[18F\]Florbetazine and will undergo a PET/CT scan.
[11C]PIB
Participants will receive a single intravenous bolus injection of 6.0-20.0mCi of the investigational radiotracer \[11C\]PIB and will undergo a PET/CT scan.
Patients with cognitive impairment
Drug: \[18F\]Florbetazine (\[18F\]92). A dosage of 10 mCi +/- 20% of Florbetazine will be injected by a PET-certified medical professional followed by 5ml 0.9% sodium chloride (normal saline) flush.
Drug: \[11C\]PIB. A dosage range between 6.0-20.0 mCi of PIB will be injected by a PET-certified medical professional followed by 5ml 0.9% sodium chloride (normal saline) flush.
[18F]Florbetazine ([18F]92)
Participants will receive a single intravenous bolus injection of 10 mCi ± 20% of the investigational radiotracer \[18F\]Florbetazine and will undergo a PET/CT scan.
[11C]PIB
Participants will receive a single intravenous bolus injection of 6.0-20.0mCi of the investigational radiotracer \[11C\]PIB and will undergo a PET/CT scan.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
[18F]Florbetazine ([18F]92)
Participants will receive a single intravenous bolus injection of 10 mCi ± 20% of the investigational radiotracer \[18F\]Florbetazine and will undergo a PET/CT scan.
[11C]PIB
Participants will receive a single intravenous bolus injection of 6.0-20.0mCi of the investigational radiotracer \[11C\]PIB and will undergo a PET/CT scan.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age ≥ 40 years
* Healthy participants or patients with probable Alzheimer's disease or with dementia due to other causes
Exclusion Criteria
* Has hypersensitivity to \[11C\]PIB or any of its excipients ;
* Incapable of providing written informed consent or lacking a legally authorized representative (LAR) to provide informed consent ;
* Unwilling or unable to undergo PET scans tracer injections ;
* Unwilling or unable to undergo MRI;
* Any condition that, in the Investigator's opinion, could increase the risk to the participant, limit the participant's ability to tolerate the research procedures, or interfere with the collection/analysis of the data (e.g., renal or liver failure, advanced cancer);
* Women who are currently pregnant or breastfeeding;
40 Years
90 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Peking Union Medical College Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Nuclear Medicine, Peking Union Medical College Hopital
Beijing, , China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Wu M, Li Y, Liang M, Mao C, Dong L, Ge Q, Wu R, Ren C, Zhang H, Huang Z, Xing H, Yang X, Wang Y, Feng F, Cui M, Gao J, Huo L. The diagnostic performance of [18F]Florbetazine in Alzheimer's disease: a head-to-head comparison to [11C]PiB and [18F]Florbetapir. Eur J Nucl Med Mol Imaging. 2025 Aug;52(10):3557-3566. doi: 10.1007/s00259-025-07233-y. Epub 2025 Apr 4.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ZineAD
Identifier Type: -
Identifier Source: org_study_id