Imaging brain amyloid in Alzheimer's disease using a new agent
[18F]Florbetazine ([18F]92) for Beta Amyloid PET Imaging in Alzheimer's Disease
This study is testing a new imaging agent to see if it can better show brain changes in people with Alzheimer's compared to current imaging methods.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 40 Years to 90 Years |
| Sex | All |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06141356 on ClinicalTrials.gov |
What this trial studies
[18F]Florbetazine ([18F]92) is an imaging agent designed to target beta-amyloid proteins associated with Alzheimer's disease. This observational study aims to evaluate its binding properties in human subjects by comparing its uptake in the brain with established imaging agents like [11C]PiB and [18F]Florbetapir. Participants will include healthy adults and those with cognitive impairments, allowing researchers to assess the agent's effectiveness in distinguishing between healthy and affected brain tissue. The study will involve PET imaging and MRI to gather comprehensive data on brain activity and structure.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 40 and older, both healthy participants and those diagnosed with probable Alzheimer's disease or other forms of dementia.
Not a fit: Patients who are allergic to the imaging agents or those with conditions that prevent them from undergoing PET scans or MRIs may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of Alzheimer's disease diagnosis and monitoring through improved imaging techniques.
How similar studies have performed: Previous studies have shown promising results with similar imaging agents, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or Female * Age ≥ 40 years * Healthy participants or patients with probable Alzheimer's disease or with dementia due to other causes Exclusion Criteria: * Has allergy to \[18F\]Florbetazine or any of its excipients ; * 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;
Where this trial is running
Beijing
- Department of Nuclear Medicine, Peking Union Medical College Hopital — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Li Huo
- Email: huoli@pumch.cn
- Phone: +861069155513
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.