Study on the Application of ¹⁸F-FCOB04, a MAO-B Targeted PET Imaging Agent, in Neurodegenerative Diseases

March 10, 2026 updated by: Peking Union Medical College Hospital
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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Early Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Aged between 18 and 75 years, regardless of gender.
  2. 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.
  3. Prior to any assessment, the subject or their legal representative has understood and signed the written informed consent form.
  4. 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.

Exclusion Criteria:

  1. 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.
  2. Suffering from claustrophobia.
  3. History of substance abuse or excessive alcohol consumption.
  4. Female subjects who are pregnant or breastfeeding.
  5. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients（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.
Drug: 18F-FCOB04
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.
Experimental: Healthy Volunteers
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.
Drug: 18F-FCOB04
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (Day 1, at the time of 18F-FCOB04 PET imaging)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 9, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

March 3, 2026

First Submitted That Met QC Criteria

March 10, 2026

First Posted (Actual)

March 13, 2026

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 10, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PUMCH-MAO-B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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