Can a new PET tracer light up Alzheimer's plaques in the living brain?
NCT ID NCT07764679
First seen Aug 14, 2026 · Last updated Aug 14, 2026
Summary
This phase III trial is evaluating whether an experimental PET imaging agent, [18F]Fluorbetazine, can accurately detect amyloid-beta plaques in the brain—a hallmark of Alzheimer's disease. The study will include about 400 adults aged 40 and older with normal cognitive function, mild cognitive impairment (MCI), or Alzheimer's dementia. Participants receive a single injection of the tracer, and the PET images are compared against a true standard to measure the test's sensitivity and specificity. The goal is to see if this tracer can reliably help diagnose Alzheimer's-related cognitive decline.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- an experimental PET imaging tracer called [18F]Fluorbetazine injection
- What this could lead to
- If successful, this could provide a more accurate and accessible way to detect Alzheimer's-related brain plaques, aiding earlier diagnosis and better clinical trials.
- What could go wrong
- The trial is still in phase III, and the tracer's accuracy and safety need confirmation. It may not be widely available or may have false positives/negatives.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 400 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1 1. Men or women aged ≥ 40 years (including the threshold age). 2. Men or women with fertility must use effective contraceptive measures during the study period. Effective contraceptive measures include sterilization, intrauterine hormone devices, condoms, birth control pills, abstinence, or vasectomy. 3\. Meet the diagnostic criteria for normal cognitive function, Mild Cognitive Impairment (MCI), or Alzheimer's disease (AD). 4\. Participants voluntarily join the study, can cooperate with the experimental observations, and sign a written informed consent form. For participants with AD dementia, the informed consent form must be signed together with their legal guardian. If the participant is unable to sign the informed consent form due to limited cognitive ability or other reasons, the participant's signature space may be left blank, with the reason documented. The guardian should sign in the designated space for explanation. Exclusion Criteria: 1. Known allergy to \[18F\]Fluorbetazine injection or its excipients. 2. Presence of previously implanted metal devices that are incompatible with MRI examinations, including pacemakers, defibrillators, insulin pumps, cochlear implants, intraocular metal implants, nerve stimulators, or CNS aneurysm clips; or suffering from claustrophobia or intolerance to imaging procedures for other reasons. 3. Cognitive impairment caused by reasons other than Alzheimer's disease (AD). 4. Cranial MRI scan shows one or more of the following results: * More than 2 infarctions with a diameter greater than 2 cm in any part of the brain; * Infarctions of any diameter in key areas such as the thalamus, hippocampus, entorhinal cortex, hippocampal gyrus, gyrus, cortex, or other subcortical gray matter nuclei; * Fazekas Scale grading of white matter lesions \> 2; * Presence of brain tumors, intracranial infections, or cerebral hemorrhage, and deemed unsuitable for participation in this study by the researchers. 5. Current clinically significant psychiatric illnesses, such as severe depression or schizophrenia, based on medical history, and the researchers have assessed that the imaging process cannot be completed. Researchers should carefully consider whether participants with dementia and behavioral disorders who may require psychiatric medication can complete the imaging process. 6. Received radiopharmaceutical imaging or treatment within at least 5 half-lives prior to screening. 7. Suffering from other serious and/or poorly controlled and/or unstable diseases, and deemed unsuitable for participation in this study by the researcher. 8. Positive test results for human immunodeficiency virus (HIV) antibodies or Treponema pallidum antibodies. 9. History of alcohol or drug abuse. 10. Pregnant or lactating women with positive pregnancy test results during the screening period (including premenopausal women who have not undergone surgical sterilization and women within one year after menopause). 11. Participated in any clinical trials within 4 weeks prior to enrollment and used investigational drugs; or those who plan to participate in any clinical trials during the study period. 12. Other situations deemed unsuitable for participating in this clinical trial by the researchers. Participants with Normal Cognitive Function 1\. Any evidence suggesting the possibility of AD from previous MRI, CT, or other biomarker studies. MCI and AD Dementia Participants 1. Received anti-Aβ targeted therapy drugs, such as lecanemab monoclonal antibody, or treated or prophylactic anti-Aβ vaccines. 2. Suffering from neurodegenerative diseases other than AD, including but not limited to Parkinson's disease, Pick's disease, frontotemporal degeneration (FTLD), Huntington's disease, Down syndrome, Creutzfeldt-Jakob disease, normal pressure hydrocephalus, or progressive supranuclear palsy (PSP). 3. Previously or currently diagnosed with dementia other than AD, including but not limited to Parkinson's disease dementia, Lewy body dementia, frontotemporal dementia, vascular dementia, mixed dementia, etc.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Peking Union Medical College Hospital
RECRUITINGBeijing, Beijing Municipality, 102413, China
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