Mild Cognitive Impairment (MCI)Phase 3NCT07764679
A Clinical Study Evaluating the Diagnostic Performance and Safety of PET for the Deposition of Aβ Plaques in the Brain of Participants With Normal Cognitive Function, MCI and AD Using [18F]Fluorbetazine Injection
A Phase 3 study testing [18F]Fluorbetazine injection in people with Mild Cognitive Impairment (MCI) and Alzheimer's Disease (AD), run by HTA Co., Ltd. at 1 site in China.
Trial summary
A multicenter phase III clinical study evaluating the diagnostic performance and safety of PET for the deposition of Aβ plaques in the brain of participants with normal cognitive function, MCI and AD using [18F]Fluorbetazine injection. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment (MCI), Alzheimer's Disease (AD)
- What is being tested?
- [18F]Fluorbetazine injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2025to 31 Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Known allergy to [18F]Fluorbetazine injection or its excipients.
- 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.
- Cognitive impairment caused by reasons other than Alzheimer's disease (AD).
- 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;
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- 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.
- 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.
- Received radiopharmaceutical imaging or treatment within at least 5 half-lives prior to screening.
- Suffering from other serious and/or poorly controlled and/or unstable diseases, and deemed unsuitable for participation in this study by the researcher.
- Positive test results for human immunodeficiency virus (HIV) antibodies or Treponema pallidum antibodies.
- History of alcohol or drug abuse.
- 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).
- 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.
- 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
- Received anti-Aβ targeted therapy drugs, such as lecanemab monoclonal antibody, or treated or prophylactic anti-Aβ vaccines.
- 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).
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 102413
Haimei Wang, Master, 15601003334, wanghaimei@hilifesmo.com
About this study
Official title: A Multicenter Phase III Clinical Study Evaluating the Diagnostic Performance and Safety of PET for the Deposition of Aβ Plaques in the Brain of Participants With Normal Cognitive Function, MCI and AD Using [18F]Fluorbetazine Injection
A multicenter phase III clinical study evaluating the diagnostic performance and safety of PET for the deposition of Aβ plaques in the brain of participants with normal cognitive function, MCI and AD using [18F]Fluorbetazine injection.
- Being tested
- [18F]Fluorbetazine injection
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]Fluorbetazine injectionDrug
normal cognitive function, mild cognitive impairment (MCI) caused by Alzheimer's disease (AD) using [18F]Fluorbetazine injection.
| Study group | Role | What they receive |
|---|---|---|
| using [18F]Fluorbetazine injection. | Experimental | Not described Receives: Drug: [18F]Fluorbetazine injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The sensitivity and specificity of PET imaging visual interpretation results compared to true standards after a single intravenous injection of [18F]Fluorbetazine injection in participants with AD induced MCI, AD dementia and normal cognitive.
The sensitivity and specificity of PET imaging visual interpretation results compared to true standards after a single intravenous injection of [18F]Fluorbetazine injection in participants with AD induced MCI, AD dementia and normal cognitive.
Measured: 1 year
Secondary outcomes (3)
1 Calculate and compare the standard uptake value ratio (SUVR) of cortical target areas (lateral temporal lobe, frontal lobe, posterior cingulate gyrus/anterior cingulate cortex, and parietal lobe) relative to the cerebellum between AD derived MCI/AD dem
1 Calculate and compare the standard uptake value ratio (SUVR) of cortical target areas (lateral temporal lobe, frontal lobe, posterior cingulate gyrus/anterior cingulate cortex, and parietal lobe) relative to the cerebellum between AD derived MCI/AD dementia participants and cognitively normal participants, and determine the diagnostic performance of SUVR;
Measured: 1year
2 Using Kappa coefficient to compare the consistency of visual analysis of PET imaging among independent readers, within readers, and overall
2 Using Kappa coefficient to compare the consistency of visual analysis of PET imaging among independent readers, within readers, and overall
Measured: 1year
3 Calculate the cerebral gray matter to white matter SUV ratio (GWR) on PET images of AD derived MCI/AD dementia participants and cognitively normal participants, and evaluate image features.
3 Calculate the cerebral gray matter to white matter SUV ratio (GWR) on PET images of AD derived MCI/AD dementia participants and cognitively normal participants, and evaluate image features.
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start20 Jun 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment (MCI)Studies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HTA Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07764679
- Sponsor's protocol ID
- HJG-YZGK-FBTQ
- Other IDs
- HTA Co., Ltd.
- Status last verified
- Aug 2026
- First submitted
- 17 Jun 2025
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individualized patient data needs to be kept confidential
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Phase III Clinical Study Evaluating the Diagnostic Performance and Safety of PET for the Deposition of Aβ Plaques in the Brain of Participants With Normal Cognitive Function, MCI and AD Using [18F]Fluorbetazine Injection
- ClinicalTrials.gov ID
- NCT07764679
- Acronym / sponsor ID
- HJG-YZGK-FBTQ
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- HTA Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Jun 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 14 Aug 2026 (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.
A multicenter phase III clinical study evaluating the diagnostic performance and safety of PET for the deposition of Aβ plaques in the brain of participants with normal cognitive function, MCI and AD using [18F]Fluorbetazine injection.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| using [18F]Fluorbetazine injection. | Experimental | Drug: [18F]Fluorbetazine injection |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (22 listed)
- Known allergy to [18F]Fluorbetazine injection or its excipients.
- 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.
- Cognitive impairment caused by reasons other than Alzheimer's disease (AD).
- Cranial MRI scan shows one or more of the following results:
- 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.
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]Fluorbetazine injectionnormal cognitive function, mild cognitive impairment (MCI) caused by Alzheimer's disease (AD) using [18F]Fluorbetazine injection. | Drug | using [18F]Fluorbetazine injection. |
Primary outcome
The sensitivity and specificity of PET imaging visual interpretation results compared to true standards after a single intravenous injection of [18F]Fluorbetazine injection in participants with AD induced MCI, AD dementia and normal cognitive.
Time frame: 1 year
The sensitivity and specificity of PET imaging visual interpretation results compared to true standards after a single intravenous injection of [18F]Fluorbetazine injection in participants with AD induced MCI, AD dementia and normal cognitive.
3 secondary outcomes
1 Calculate and compare the standard uptake value ratio (SUVR) of cortical target areas (lateral temporal lobe, frontal lobe, posterior cingulate gyrus/anterior cingulate cortex, and parietal lobe) relative to the cerebellum between AD derived MCI/AD dem
Time frame: 1year
2 Using Kappa coefficient to compare the consistency of visual analysis of PET imaging among independent readers, within readers, and overall
Time frame: 1year
3 Calculate the cerebral gray matter to white matter SUV ratio (GWR) on PET images of AD derived MCI/AD dementia participants and cognitively normal participants, and evaluate image features.
Time frame: 1year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: No. Individualized patient data needs to be kept confidential
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing [18F]Fluorbetazine injection in people with Mild Cognitive Impairment (MCI) and Alzheimer's Disease (AD), run by HTA Co., Ltd. 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 22 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: looking for participants now, as of the sponsor's last update on 14 Aug 2026. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaomin Xu, Master (010-69357316, xuxiaomin@circ.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The sensitivity and specificity of PET imaging visual interpretation results compared to true standards after a single intravenous injection of [18F]Fluorbetazine injection in participants with AD induced MCI, AD dementia and normal cognitive. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Aug 2026; AzTrials last refreshed its copy on 30 Oct 2026.