Alzheimer's DiseaseNCT06141356
[18F]Florbetazine ([18F]92) for Beta Amyloid PET Imaging in Alzheimer's Disease
An observational study of Alzheimer's Disease, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
[18F]Florbetazine ([18F]92) is a molecularly targeted imaging agent for Aβ protein with a novel diaryl-azine scaffold. It has shown specific binding affinity to Aβ aggregates in postmortem human AD brains and excellent brain pharmacokinetic properties with little non-specific retention in white matter in animal… Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- [18F]Florbetazine ([18F]92) and [11C]PIB
- Type of treatment
- Injection or infusion
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 30 Jan 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- Adult, Older adult
Study population: Healthy participants of patients with probable Alzheimer's disease or with dementia due to other causes
Who may be able to join
- Male or Female
- Age ≥ 40 years
- Healthy participants or patients with probable Alzheimer's disease or with dementia due to other causes
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Nuclear Medicine, Peking Union Medical College Hopital
Beijing, 100730
Li Huo, 86-10-13910801986, huoli@pumch.cn
Meiqi Wu, +8618810309905, wumqpumch@126.com
About this study
[18F]Florbetazine ([18F]92) is a molecularly targeted imaging agent for Aβ protein with a novel diaryl-azine scaffold. It has shown specific binding affinity to Aβ aggregates in postmortem human AD brains and excellent brain pharmacokinetic properties with little non-specific retention in white matter in animal studies and a limited number of patients with Alzheimer's Disease (AD).
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.
- Conditions
- Alzheimer's Disease
- Being tested
- [18F]Florbetazine ([18F]92), [11C]PIB
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]Florbetazine ([18F]92)Drug
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]PIBDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: [18F]Florbetazine ([18F]92); Drug: [11C]PIB | |
| 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. Receives: Drug: [18F]Florbetazine ([18F]92); Drug: [11C]PIB |
What is being measured
The primary outcome is the main question the study is designed to answer.
The non-displacable binding potential (BPND) of [18F]Florbetazine in healthy participants and patients with probable AD
Dynamic PET data in list-mode is required over 90 minutes in participants. The PET data will be reconstructed into specific dynamic series for kinetic modeling. The non-displacable binding potential (BPND) will be determined in target and reference tissues and compared between healthy participants and patients with probable AD.
Measured: 1 year
The distribution volume ratio (DVR) of [18F]Florbetazine in healthy participants and patients with probable AD
Dynamic PET data in list-mode is required over 90 minutes in participants. The PET data will be reconstructed into specific dynamic series for kinetic modeling. The distribution volume ratio (DVR) will be determined in target and reference tissues and compared between healthy participants and patients with probable AD.
Measured: 1 year
Comparison of the cortical and white matter binding of [18F]Florbetazine ([18F]92) with [11C]PIB in healthy participants and patients with cognitive decline
[18F]Florbetazine ([18F]92) PET and [11C]PIB PET will be conducted in the same subjects. standardized uptake value ratios of determined cortical and white matter regions will be calculated for both tracers and then compared.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start30 Jan 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06141356
- Sponsor's protocol ID
- ZineAD
- Status last verified
- Nov 2023
- First submitted
- 11 Nov 2023
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40183954Wu M, Ren C, Mao C, Dong L, Li B, Yang X, Huang Z, Zhang H, Li Y, Yan M, Ge Q, Wu R, Feng F, Cui M, Gao J, Huo L. Evaluation of a novel PET tracer [18F]-Florbetazine for Alzheimer's disease diagnosis and beta-amyloid deposition quantification. Neuroimage. 2024 Sep;298:120779. doi: 10.1016/j.neuroimage.2024.120779. Epub 2024 Aug 8.
PubMed 39122059
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- [18F]Florbetazine ([18F]92) for Beta Amyloid PET Imaging in Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT06141356
- Acronym / sponsor ID
- ZineAD
- Conditions
- Alzheimer's Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 21 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
[18F]Florbetazine ([18F]92) is a molecularly targeted imaging agent for Aβ protein with a novel diaryl-azine scaffold. It has shown specific binding affinity to Aβ aggregates in postmortem human AD brains and excellent brain pharmacokinetic properties with little non-specific retention in white matter in animal studies and a limited number of patients with Alzheimer's Disease (AD).
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy participants | – | Drug: [18F]Florbetazine ([18F]92), Drug: [11C]PIBDrug: [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. |
| Patients with cognitive impairment | – | Drug: [18F]Florbetazine ([18F]92), Drug: [11C]PIBDrug: [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. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Healthy participants of patients with probable Alzheimer's disease or with dementia due to other causes
Key inclusion criteria (3 listed)
- Male or Female
- Age ≥ 40 years
- Healthy participants or patients with probable Alzheimer's disease or with dementia due to other causes
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [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. | Drug | Healthy participants, Patients with cognitive impairment |
| [11C]PIBParticipants 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. | Drug | Healthy participants, Patients with cognitive impairment |
Primary outcome
The non-displacable binding potential (BPND) of [18F]Florbetazine in healthy participants and patients with probable AD
Time frame: 1 year
Dynamic PET data in list-mode is required over 90 minutes in participants. The PET data will be reconstructed into specific dynamic series for kinetic modeling. The non-displacable binding potential (BPND) will be determined in target and reference tissues and compared between healthy participants and patients with probable AD.
The distribution volume ratio (DVR) of [18F]Florbetazine in healthy participants and patients with probable AD
Time frame: 1 year
Dynamic PET data in list-mode is required over 90 minutes in participants. The PET data will be reconstructed into specific dynamic series for kinetic modeling. The distribution volume ratio (DVR) will be determined in target and reference tissues and compared between healthy participants and patients with probable AD.
Comparison of the cortical and white matter binding of [18F]Florbetazine ([18F]92) with [11C]PIB in healthy participants and patients with cognitive decline
Time frame: 2 years
[18F]Florbetazine ([18F]92) PET and [11C]PIB PET will be conducted in the same subjects. standardized uptake value ratios of determined cortical and white matter regions will be calculated for both tracers and then compared.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Derived from this study: PubMed 40183954Wu 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.
- Derived from this study: PubMed 39122059Wu M, Ren C, Mao C, Dong L, Li B, Yang X, Huang Z, Zhang H, Li Y, Yan M, Ge Q, Wu R, Feng F, Cui M, Gao J, Huo L. Evaluation of a novel PET tracer [18F]-Florbetazine for Alzheimer's disease diagnosis and beta-amyloid deposition quantification. Neuroimage. 2024 Sep;298:120779. doi: 10.1016/j.neuroimage.2024.120779. Epub 2024 Aug 8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer's Disease, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Huo (+861069155513, huoli@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The non-displacable binding potential (BPND) of [18F]Florbetazine in healthy participants and patients with probable AD (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06141356, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2023; AzTrials last refreshed its copy on 8 Nov 2026.