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

NCT07470710 | Not Yet Recruiting Early Phase 1

• 1 other identifier: PUMCH-MAO-B
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (Day 1, at the time of 18F-FCOB04 PET imaging)

Study Arms (2)

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.

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.

Drug: 18F-FCOB04

Interventions

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.

Healthy Volunteers; Patients（Experimental）

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

MeSH Terms

Conditions

Neurodegenerative Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2026
• First Posted: March 13, 2026
• Study Start: March 9, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share