Neurodegenerative DiseasesEarly Phase 1NCT07470710
Study on the Application of ¹⁸F-FCOB04, a MAO-B Targeted PET Imaging Agent, in Neurodegenerative Diseases
A Early Phase 1 study testing 18F-FCOB04 in people with Neurodegenerative Diseases, run by Peking Union Medical College Hospital.
Trial summary
In this clinical trial, we intend to perform 18F-FCOB04 PET imaging in patients with neurodegenerative diseases to observe the brain uptake of this tracer.We will investigate the distinct imaging patterns of brain MAO-B expression in patients with various neurodegenerative diseases.Correlation analysis will be… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurodegenerative Diseases
- What is being tested?
- 18F-FCOB04
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 9 Mar 2026to 31 Dec 2026
- Phase
- Early Phase 1
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged between 18 and 75 years, regardless of gender.
- Patients diagnosed with probable or possible neurodegenerative diseases by a specialist neurologist according to current internationally recognized clinical diagnostic criteria, including but not limited to Alzheimer's disease, Parkinson's disease, and Parkinsonian syndromes (such as progressive supranuclear palsy, multiple system atrophy, corticobasal degeneration, etc.).Diagnosis is based on a comprehensive evaluation including systematic medical history collection, neurological examination, relevant neuropsychological or motor function scale assessments, combined with conventional structural neuroimaging such as cranial MRI.Patients with a history of brain surgery, brain cyst, brain tumor, or other comorbidities that may affect data analysis are excluded.
- Prior to any assessment, the subject or their legal representative has understood and signed the written informed consent form.
- Subjects who are currently using, or have not used MAO-B inhibitors (including but not limited to selegiline, rasagiline, safinamide) for ≥14 days prior to enrollment.
Who cannot join
- Suffering from other severe neurological diseases, or severe diseases of the gastrointestinal, cardiovascular, hepatic, renal, hematological, oncological, endocrine, respiratory, immunodeficiency or other severe systemic disorders.
- Suffering from claustrophobia.
- History of substance abuse or excessive alcohol consumption.
- Female subjects who are pregnant or breastfeeding.
- Presence of any condition that, in the opinion of the investigator, may be harmful or potentially harmful to the subject in any procedure related to this study.
About this study
In this clinical trial, we intend to perform 18F-FCOB04 PET imaging in patients with neurodegenerative diseases to observe the brain uptake of this tracer.We will investigate the distinct imaging patterns of brain MAO-B expression in patients with various neurodegenerative diseases.Correlation analysis will be conducted between imaging findings and relevant clinical indicators.This study aims to evaluate the role of 18F-FCOB04 in the auxiliary diagnosis of neurodegenerative diseases, as well as to assess the tolerability and safety of the tracer and the imaging procedure.
- Conditions
- Neurodegenerative Diseases
- Being tested
- 18F-FCOB04
- Medical subject headings
- Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FCOB04Drug
Single intravenous administration of the investigational PET radiotracer 18F-FCOB04 followed by PET/CT imaging for evaluation of safety, biodistribution, radiation dosimetry, and target-specific uptake.
| Study group | Role | What they receive |
|---|---|---|
| Patients（Experimental） | Experimental | Patients with neurodegenerative diseases will receive a single intravenous injection of the investigational PET tracer 18F-FCOB04 followed by PET/CT imaging for evaluation of biodistribution and lesion uptake. Receives: Drug: 18F-FCOB04 |
| Healthy Volunteers | Experimental | Healthy participants will receive a single intravenous injection of the investigational PET tracer 18F-FCOB04 followed by PET/CT imaging for safety and dosimetry assessment. Receives: Drug: 18F-FCOB04 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional standardized uptake value ratio (SUVR) on 18F-FCOB04 PET
Regional standardized uptake value ratio (SUVR) measured on 18F-FCOB04 positron emission tomography (PET) images. SUVR is defined as the ratio of tracer uptake in a predefined target brain region to uptake in a predefined reference region. The measurement unit is unitless. SUVR will be calculated using PET image analysis software based on predefined regions of interest.
Measured: Baseline (Day 1, at the time of 18F-FCOB04 PET imaging)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start9 Mar 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurodegenerative DiseasesStudies 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 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
- NCT07470710
- Sponsor's protocol ID
- PUMCH-MAO-B
- Status last verified
- Feb 2026
- First submitted
- 3 Mar 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Application of ¹⁸F-FCOB04, a MAO-B Targeted PET Imaging Agent, in Neurodegenerative Diseases
- ClinicalTrials.gov ID
- NCT07470710
- Acronym / sponsor ID
- PUMCH-MAO-B
- Conditions
- Neurodegenerative Diseases
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 9 Mar 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Mar 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.
In this clinical trial, we intend to perform 18F-FCOB04 PET imaging in patients with neurodegenerative diseases to observe the brain uptake of this tracer.We will investigate the distinct imaging patterns of brain MAO-B expression in patients with various neurodegenerative diseases.Correlation analysis will be conducted between imaging findings and relevant clinical indicators.This study aims to evaluate the role of 18F-FCOB04 in the auxiliary diagnosis of neurodegenerative diseases, as well as to assess the tolerability and safety of the tracer and the imaging procedure.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients（Experimental） | Experimental | Drug: 18F-FCOB04Patients with neurodegenerative diseases will receive a single intravenous injection of the investigational PET tracer 18F-FCOB04 followed by PET/CT imaging for evaluation of biodistribution and lesion uptake. |
| Healthy Volunteers | Experimental | Drug: 18F-FCOB04Healthy participants will receive a single intravenous injection of the investigational PET tracer 18F-FCOB04 followed by PET/CT imaging for safety and dosimetry assessment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged between 18 and 75 years, regardless of gender.
- Patients diagnosed with probable or possible neurodegenerative diseases by a specialist neurologist according to current internationally recognized clinical diagnostic criteria, including but not limited to Alzheimer's disease, Parkinson's disease, and Parkinsonian syndromes (such as progressive supranuclear palsy, multiple system atrophy, corticobasal degeneration, etc.).Diagnosis is based on a comprehensive evaluation including systematic medical history collection, neurological examination, relevant neuropsychological or motor function scale assessments, combined with conventional structural neuroimaging such as cranial MRI.Patients with a history of brain surgery, brain cyst, brain tumor, or other comorbidities that may affect data analysis are excluded.
- Prior to any assessment, the subject or their legal representative has understood and signed the written informed consent form.
- Subjects who are currently using, or have not used MAO-B inhibitors (including but not limited to selegiline, rasagiline, safinamide) for ≥14 days prior to enrollment.
Key exclusion criteria (5 listed)
- Suffering from other severe neurological diseases, or severe diseases of the gastrointestinal, cardiovascular, hepatic, renal, hematological, oncological, endocrine, respiratory, immunodeficiency or other severe systemic disorders.
- Suffering from claustrophobia.
- History of substance abuse or excessive alcohol consumption.
- Female subjects who are pregnant or breastfeeding.
- Presence of any condition that, in the opinion of the investigator, may be harmful or potentially harmful to the subject in any procedure related to this study.
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-FCOB04Single intravenous administration of the investigational PET radiotracer 18F-FCOB04 followed by PET/CT imaging for evaluation of safety, biodistribution, radiation dosimetry, and target-specific uptake. | Drug | Healthy Volunteers, Patients（Experimental） |
Primary outcome
Regional standardized uptake value ratio (SUVR) on 18F-FCOB04 PET
Time frame: Baseline (Day 1, at the time of 18F-FCOB04 PET imaging)
Regional standardized uptake value ratio (SUVR) measured on 18F-FCOB04 positron emission tomography (PET) images. SUVR is defined as the ratio of tracer uptake in a predefined target brain region to uptake in a predefined reference region. The measurement unit is unitless. SUVR will be calculated using PET image analysis software based on predefined regions of interest.
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 13 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Neurodegenerative Diseases
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
Active, not recruitingPhase 4
A Study Evaluating the Effectiveness and Safety of Risdiplam Administered as an Early Intervention in Pediatric Participants With Spinal Muscular Atrophy After Gene Therapy
Muscular Atrophy, Spinal
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 18F-FCOB04 in people with Neurodegenerative Diseases, run by Peking Union Medical College Hospital.
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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
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?
Regional standardized uptake value ratio (SUVR) on 18F-FCOB04 PET (time frame: Baseline (Day 1, at the time of 18F-FCOB04 PET imaging)). 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 13 Mar 2026.