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MCIPhase 1NCT06593626

A Phase I Clinical Study on the Safety and Pharmacokinetics of [18F]Florbetazine Injection

A Phase 1 study testing [18F]Florbetazine in people with MCI and AD, run by HTA Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a phase-1 study that aims to evaluate the safety and pharmacokinetics of [18F]Florbetazine injection in healthy subjects and patients with MCI and AD. This study has evaluated and compared the distributed patterns of [18F]Florbetazine injection in healthy subjects and patients with AD and MCI. Read more about this study

Who is it for?
Ages 50 to 85 yearsHealthy volunteers can take part
Conditions the study is for
MCI, AD
What is being tested?
[18F]Florbetazine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteChina
Study dates
6 Nov 2023to 30 Jun 2025
Phase
Phase 1
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 50 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • For all subjects
  • Male and Female subjects aged 50-85 years (including 50 ang 85 years);
  • Fertile men or women must use effective birth control during the study period (effective contraception means sterilization, intrauterine hormonal devices, condoms, contraceptives/pills, abstinence or excision vas deferens, etc.) For healthy subjects
  • <!-- -->
  • Sign informed consent;
  • Good health status or no major diseases are judged by the researcher based on the following assessments: medical history, health results of vital signs, physical examination, clinical electrocardiogram and clinical laboratory examination;
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  • Normal blood routine, blood biochemistry, urine routine and coagulation routine during the screening period, or abnormal without clinical significance;
  • According to neuropsychological tests and researchers' judgment, no cognitive impairment;
  • The score of clinical dementia rating (CDR) is 0;
  • The score of mini-mental state examination (MMSE) is equal or greater than 27; For MCI patients
  • <!-- -->
  • Sign informed consent;
  • Diagnosed as Alzheimer's disease-related mild cognitive impairment (AD-MCI) according to the diagnostic criteria of NIA-AA;
  • The Aβ-PET imaging displays positive result;
  • The score of clinical dementia rating (CDR) is 0.5;
  • The score of mini-mental state examination (MMSE) is equal or less than 27; For AD patients
  • <!-- -->
  • Sign informed consent;
  • According to NIA-AA clinical criteria, the patients could be diagnosed as AD dementia;
  • The Aβ-PET imaging displays positive result;
  • Mild to moderate dementia, and the score of clinical dementia rating (CDR) is 1 or 2;
  • The score of mini-mental state examination (MMSE) is 10-17 (illiteracy), or 10-22 (primary school graduate), or 10-24 (middle school graduate), or 10-26 (college and above graduate), the score with upper and lower limits.
  • Caregivers who live with the patient or regularly look after the patient are willing to provide information about the patient's cognitive status

Who cannot join

  • For all subjects
  • Pregnant (positive pregnancy test during screening) or breastfeeding women;
  • A history of alcohol or drug abuse/dependence;
  • Known allergies to radiation and alcohol, or other severe allergies;
  • Human immunodeficiency virus (HIV), hepatitis C virus (HCV) or treponema pallidum antibody test positive, hepatitis B virus (HBV) surface antigen positive;
  • A history of liver disease or other conditions that interfere with drug absorption, distribution, excretion, or metabolism as determined by the investigator;
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  • Blood clotting history or blood clotting disorder;
  • The subject has cognitive impairment due to causes other than AD, including but not limited to: a. Injuries caused by acute or post-traumatic brain injury, subdural hematoma, or chronic trauma: e.g. boxing sequelae; b. Hypoxic brain injury (regardless of cause) : cognitive or neurological impairment, such as cardiac arrest or cardiac surgery, anesthesia, or severe autotoxic episodes secondary to severe hypovolemia (orthostatic hypotension does not result in exclusion of subjects); c. Confirm vitamin deficiency status based on medical history: such as folic acid, vitamin B12 and other B complex vitamins deficiency; Such as vitamin B1 deficiency in Korsakoff syndrome (note: subjects taking regular B12 and folic acid do not necessarily need to be excluded); d. Brain infections, including abscesses, syphilis, meningitis, encephalitis, or AIDS; e. Primary or metastatic brain tumors; f. Toxic diseases, such as chronic alcoholism, organic poisoning, CO poisoning; g. Significant endocrine or metabolic diseases such as thyroid, parathyroid or pituitary diseases, Cushing's syndrome or severe renal failure; h. Mental retardation;
  • The subject has clinically significant infarction or possible multiple infarct dementia, including: a. A history of significant cerebrovascular events leading to physical or neurological impairment, which may affect the assessment of the subject's intellectual function; b. Neurological examination showed a variety of focal signs of the nervous system, suggesting multiple ischemic attacks; (1) Multiple (2 or more) infarcts or critical site infarcts: a large (>1.5 cm in diameter) infarct in the area of the cerebral angular gyrus, thalamus, basal forebrain, posterior cerebral artery (PCA), or anterior cerebral artery (ACA); ② Widespread periventricular white matter disease. A distinction needs to be made between leukoosteoporosis (periventricular white matter, low attenuation) and multiple cerebral infarction. Leukoosteoporosis is a common condition in the normal population and in Alzheimer's disease. Leukodegeneration will not result in exclusion of subjects unless it is abnormal and widespread, as in Binswanger disease.
  • The present presence of clinically significant mental illness based on medical history, especially the present presence of major depression or schizophrenia;
  • A history of epilepsy or convulsions, but not febrile convulsions in childhood;
  • Significant occupational exposure to ionizing radiation (e.g., more than 50 MSV/year) within the past 10 years;
  • Unable to repeat venipuncture;
  • Have had metal devices implanted that are not compatible with MR, including pacemakers or defibrillators, insulin pumps, cochlear implants, intraocular metal implants, nerve stimulators, CNS aneurysm clips, etc., or have claustrophobia or cannot tolerate imaging procedures for other reasons;
  • received any drug or treatment before enrollment that the investigator determines may interfere with the trial data or may cause serious side effects and is not fully eluted;
  • Participating in other drug clinical studies and using other investigational drugs within 30 days prior to screening;
  • Subjects received radiopharmaceutical imaging or treatment within 7 days prior to screening;
  • Other conditions that the investigator considers inappropriate to participate in the clinical trial; For healthy subjects
  • <!-- -->
  • Have a history of dementia or other genetic history;
  • Meet the criteria for MCI or dementia diagnosis, or have been diagnosed before;
  • Have been on medication for cognitive impairment or dementia;
  • Any previous major illness or unstable condition (e.g. unstable angina pectoris, dilated or hypertrophic cardiomyopathy, valvular heart disease, congenital heart disease, myocardial infarction or coronary revascularization, heart failure, chronic kidney failure, chronic liver disease, severe lung disease, blood disease, diabetes, chronic infection, epilepsy, mental illness); For AD patients
  • <!-- -->
  • Have received a non-vaccine investigational treatment for Alzheimer's disease or other dementias within the last 3 months (or 5 half-lives of the drug, whichever is older), or have received a passive immunotherapy drug (antibody) used to treat Alzheimer's disease or other dementias within the last 6 months, or have previously received a vaccine used to treat Alzheimer's disease or other dementias;
  • Have neurodegenerative diseases other than Alzheimer's disease, including but not limited to: Parkinson's disease, Pick's disease, frontotemporal degeneration (FTLD), Huntington's disease, Down's syndrome, Creutzfeldt-Jakya disease, normal pressure hydrocephalus, and progressive suprachinuclear palsy (PSP);
  • Have been or are 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.

China1 site

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100853

Other trials in China

About this study

Official title: A Phase I Clinical Study on the Safety and Pharmacokinetics of [18F]Florbetazine Injection in Healthy Subjects and Patients With Amyloid Fibrils

This study is a phase-1 study that aims to evaluate the safety and pharmacokinetics of [18F]Florbetazine injection in healthy subjects and patients with MCI and AD.

This study has evaluated and compared the distributed patterns of [18F]Florbetazine injection in healthy subjects and patients with AD and MCI.

Conditions
MCI, AD
Being tested
[18F]Florbetazine
Keywords
18F, MCI, AD, phase Ⅰ

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [18F]FlorbetazineDrug

    Evaluate the safety of [18F]Florbetazine injection in AD and MCI patients, and healthy subjects.

Study groups in NCT06593626
Study groupRoleWhat they receive
[18F]Florbetazine, 10mCiExperimentalEvaluate the safety and pharmacokinetics of [18F]Florbetazine injection in healthy subjects.
Receives: Drug: [18F]Florbetazine
[18F]Florbetazine, 10mCi, 8mCi, 5mCiExperimentalAD and MCI
Receives: Drug: [18F]Florbetazine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and tolerability: Adverse events (AE) and their incidence during the trial,

    Safety and tolerability: Adverse events (AE) and their incidence during the trial, clinical symptoms and signs (including vital signs), laboratory findings.

    Measured: 30 day

Secondary outcomes (3)

  1. Standard uptake value ratio

    Evaluation of the standard uptake value ratio (SUVR) of [18F]Florbetazine injection in the regions of interesting (ROI), and the whole cerebellum is regarded as reference region.

    Measured: The whole process from collection to follow-up trial was completed

  2. Bio-distribution

    At different time points after drug injection, perform PET/CT whole-body scans to obtain radioactivity counts (%ID) in major irradiated organs at each phase, reflecting the drug's biodistribution in the body.

    Measured: The whole process from collection to follow-up trial was completed

  3. Multi-dose exploration

    PET/CT scan images, including measuring the standardized uptake value (SUV) within the integrated region of interest (iROI), subjective assessment of image quality, to evaluate the impact of drug dose on image quality.

    Measured: The whole process from collection to follow-up trial was completed

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start6 Nov 2023
  3. Primary completion30 Jun 2025
  4. Study completion30 Jun 2025

Resources

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 1
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Single group
Model description
Single-center, multi-dose, open-dosing study
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06593626
Sponsor's protocol ID
YZGK-FBZ-Ι-001
Status last verified
Sep 2024
First submitted
24 May 2024
Last updated
10 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Li Y, Pan M, Yu H, Zhang Q, Chang Y, Zhao H, Wang J, Wang X, Dai J, Yu L, Chen D, Zhang J, Yan XX, Yao S, Cui M. Preclinical and preliminary clinical evaluation of [18F]Florbetazine for non-invasive PET detection of cardiac amyloidosis. Eur J Nucl Med Mol Imaging. 2026 Apr;53(5):3364-3374. doi: 10.1007/s00259-025-07719-9. Epub 2026 Jan 10.

    PubMed 41518400

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [18F]Florbetazine in people with MCI and 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 23 inclusion and 27 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: finished, as of the sponsor's last update on 10 Jul 2025. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerability: Adverse events (AE) and their incidence during the trial, (time frame: 30 day). 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 NCT06593626, which also lists 1 linked publication.

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 10 Jul 2025.

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