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Radiopharmaceutical

[18F]UCB-2897 for Multi-System Atrophy

Phase 1

Waitlist Available

Led By Joyce Gibbons, PA-C

Research Sponsored by Invicro

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up screening, pre-injection, and at the completion of imaging

Awards & highlights

Study Summary

This trial will test the safety and effectiveness of a new imaging agent, [18F]UCB-2897, in people with Parkinson's disease or Multiple System Atrophy. The goal is to see if the agent can produce a specific signal in the brain related to alpha-synuclein, a protein involved in these diseases.

Eligible Conditions

Multi-System Atrophy
Parkinson's Disease
Healthy Subjects

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ [18f]ucb-2897 pet imaging visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~[18f]ucb-2897 pet imaging visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and [18f]ucb-2897 pet imaging visit for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Quantitative analysis of [18F]UCB-2897 brain PET scans

Safety Outcome Measures

Whole-body Biodistribution Outcome Measures

Trial Design

1Treatment groups

Experimental Treatment

Group I: [18F]UCB-2897Experimental Treatment1 Intervention

Administration of Investigational Agent: Study center personnel will administer [18F]UCB-2897 as an IV injection. Prior to PET imaging, participants will have an IV catheter (for radiopharmaceutical administration) inserted according to standard clinical practice. Each participant will receive a single injection of [18F]UCB-2897. [18F]UCB-2897 will be injected IV at a dose of not more than 10 mCi, with a maximum mass dose of 10 μg and maximum volume of 10 mL. The injection will be followed by a 10 mL saline flush. Qualified study staff will accompany participants during PET imaging procedures.

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

InvicroLead Sponsor

16 Previous Clinical Trials

371 Total Patients Enrolled

Joyce Gibbons, PA-CPrincipal InvestigatorSub-Investigator

Amy Knorr, MDPrincipal InvestigatorSub-Investigator

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent is the participant pool of this research project expanding?

"That is accurate. According to the information on clinicaltrials.gov, this medical trial was initially posted on January 31st 2022 and last modified on March 1st 2022. Currently, there are 14 patients needed across one single site for the study's completion."

Answered by AI

Are there any current opportunities to join this experiment?

"According to the records hosted on clinicaltrials.gov, this trial is searching for participants; it was published at the beginning of January 2021 and underwent its most recent update in March 2022."

Answered by AI

What are the potential hazards associated with administering [18F]UCB-2897?

"Due to the limited data available, [18F]UCB-2897 was assigned a score of 1 in terms of safety on our team's scale. This is because this trial only reaches Phase 1 status and there is restricted information confirming efficacy or security."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Proof of Mechanism Study to Evaluate Binding of Alfa-synuclein

2022. "Proof of Mechanism Study to Evaluate Binding of Alfa-synuclein". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05274568.