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

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorPeking Union Medical College Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • 18F-FCOB04

Treatment groups

40 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Peking Union Medical College Hospital

Lead sponsor