An Early Phase 1 interventional study of 18F-CP6A in Synucleinopathies, sponsored by Wuhan Union Hospital, China. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-14.
Sponsored by Wuhan Union Hospital, China · Early Phase 1, Interventional, and Diagnostic
Synucleinopathies are a group of severe neurodegenerative diseases, including Parkinson's Disease (PD), Dementia with Lewy Bodies (DLB), and Multiple System Atrophy (MSA). A common feature of these diseases is the pathological aggregation of α-synuclein (α-Syn), which forms Lewy Bodies (LBs), directly causing neuronal damage and death. Clinically, these diseases can present similar parkinsonian syndromes, making differential diagnosis more challenging. However, they may exhibit significant differences in the distribution and morphology of α-Syn pathology. For example, in MSA, the pathological α-Syn primarily accumulates in oligodendrocytes, particularly in the brainstem and cerebellar white matter, which differs significantly from the neuronal Lewy Body formation seen in PD and DLB.
Currently, imaging biomarkers related to β-amyloid (Aβ) and tau proteins have been widely used in clinical diagnosis and research. However, imaging biomarkers targeting α-Syn are still relatively lacking, which limits the early diagnosis and accurate subtyping of these diseases.
In recent years, some PET imaging agents targeting α-Syn have demonstrated good affinity in vitro and in animal experiments, significantly outperforming other common neurodegenerative biomarkers, including Aβ and tau proteins. These agents show promising potential in aiding the diagnosis of synucleinopathies. Professor Ye Keqiang's team at Shenzhen University of Technology has previously developed a small molecule compound (F0502B) with high affinity and selectivity for α-Syn aggregates. Early in vivo and in vitro experiments showed that it could specifically bind to LBs and quantify the amount of LBs in the brain, aiding the early detection of preclinical PD patients and dynamic monitoring of disease progression. Further optimization of the F0502B compound led to the development of its derivative, CP6A. The 18F-labeled probe of CP6A preferentially highlights α-Syn deposition in the brains of animal models and has demonstrated good safety in both mice and monkeys.
Based on the above, this project intends to include clinically diagnosed or highly probable synucleinopathy patients and healthy volunteers, using the 18F-labeled derivative of the α-synuclein-specific imaging agent, 18F-CP6A, to perform integrated PET imaging. The goal is to explore the in vivo safety, pharmacokinetics, and clinical application value of 18F-CP6A in synucleinopathies.
Neurodegenerative diseases represent a significant global health challenge. With the increasing life expectancy, it is estimated that by 2050, the number of individuals suffering from dementia will reach 50 million. Among these diseases, Parkinson's disease (PD) is the second most common neurodegenerative disease, following Alzheimer's disease (AD). The typical pathological features of PD include the loss of dopaminergic neurons and the accumulation of α-synuclein (α-Syn), leading to the formation of Lewy bodies. Other diseases with similar pathological features of α-Syn accumulation include Dementia with Lewy Bodies (DLB) and Multiple System Atrophy (MSA). However, many neurodegenerative diseases, including those related to synucleinopathies, can present with similar parkinsonian syndromes, making differential diagnosis challenging.
α-Synuclein has emerged as a potential diagnostic and differential diagnostic biomarker for synucleinopathies. The deposition of α-Syn is a common characteristic of these diseases, and pathological examinations have shown significant heterogeneity in the deposition patterns across different synucleinopathies. In PD, α-Syn typically appears as intracellular inclusions within neurons, first appearing in the brainstem, then spreading to the midbrain/substantia nigra, and eventually to the medial temporal cortex and neocortex. In DLB, α-Syn distribution is more widespread in cortical regions compared to PD, while in MSA, α-Syn deposits are primarily found in oligodendrocytes, particularly in the white matter of the brainstem and cerebellum. Therefore, in vivo imaging of α-Syn could be an important tool for diagnosing and differentiating synucleinopathies.
Positron emission tomography (PET) has been widely used for diagnosing neurodegenerative diseases, using probes targeting amyloid β (Aβ) and tau proteins for AD. However, the deposition of α-Syn is usually less prominent than that of Aβ and tau. Additionally, dopamine transporter (DAT) and vesicular monoamine transporter type 2 (VMAT2) imaging are also used for diagnosing PD but are less effective for distinguishing atypical Parkinsonism or other conditions affecting the nigrostriatal pathway. These imaging techniques are also highly sensitive to the effects of dopaminergic medications, which can alter the imaging results. To address these challenges, researchers have developed highly selective α-Syn imaging agents, enabling early diagnosis and monitoring of disease progression in synucleinopathies.
This study aims to evaluate the safety, diagnostic potential, pharmacokinetics, and radiation dose of the α-Syn specific imaging agent, 18F-CP6A, in patients diagnosed with PD, MSA, and DLB, as well as healthy volunteers, using integrated PET/MRI imaging. The specific objectives are:
38 studies on the registry are indexed under Synucleinopathies; 23 are open to participants now.
This study's planned enrollment of 18 is below the median of 31 across 21 interventional studies indexed under Synucleinopathies.
Browse Synucleinopathies studies →Wuhan Union Hospital, China is the lead sponsor of 229 studies on the registry; 103 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Healthy Volunteers:
Synucleinopathy Patients:
Exclusion Criteria:
Healthy Volunteers:
Synucleinopathy Patients:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Determine if targeting α-synuclein PET is safe and effective method for imaging of synucleinopathies
Drug: 18F-CP6A
For pharmacokinetics, healthy volunteers underwent PET imaging targeting α-synuclein. Blood samples were collected at before and 2 ± 1, 5 ± 2, 10 ± 2, 30 ± 5, 60 ± 5, 90 ± 5, and 120 ± 10 min after imaging agent injection, and urine specimens were collected at before and 0-1.5, and 1.5-3 h after injection to measure radioactivity in blood and urine. PET/MR and PET/CT scans were performed at 0 ± 10, 30 ± 10, 60 ± 10, and 100 ± 10 min after injection to understand distribution for healthy volunteers and synucleinopathy patients. A separate 10-minute PET scan of the brain is required of each acquisition. Blood tests, liver and kidney function, and other biochemical markers must be performed one week prior to and after imaging.
Visual and standardized uptake values assessment of biodistribution
At least two experienced nuclear medicine physicians will conduct a visual analysis using consensus reading. The standardized uptake value (SUV) of brain and other organs will be measured after a semiquantitative analysis is conducted for each case. The SUV ranges from 0 to infinity, and a higher score means a higher uptake of targeting α-synuclein probe by the tumor, which implies a greater possibility of synucleinopathies.
Time frame: From enrollment to the end of imaging at 4 weeks
Radioactivity in the blood and urine samples
Blood samples will be collected at before injection of 18F-CP6A, and 2 ± 1、5 ± 2、10 ± 2、30 ± 5、60 ± 5、90 ± 5、120 ± 10 minutes after injection. Urine samples were collected at before injection of 18F-CP6A, and 0-1.5 and 1.5-3 hours after injection. Radioactivity in the blood and urine samples will be measured by gamma counters.
Time frame: From enrollment to the end of imaging at 4 weeks
Radiation doses in healthy subjects
Calculate the radiation equivalent dose (in mSv/MBq) to each organ tissue in healthy subjects, including: brain, heart, liver, spleen, lungs and kidneys, using OLINDA/EXM software.
Time frame: From enrollment to the end of imaging at 4 weeks
Start is estimated for Feb 2025; primary completion for Dec 2026, 22 months later.
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