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NCT Number: NCT07470710

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

18F-FCOB04

Drug

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 13, 2026
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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