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Radiopharmaceutical
Proof of Mechanism Study to Evaluate Binding of Alfa-synuclein
Phase 1
Waitlist Available
Led By David Russell, MD, Ph.D
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
No Placebo-Only Group
Summary
This trial uses a special substance to detect specific brain proteins in people with Parkinson's Disease, Multiple System Atrophy, and healthy volunteers. The substance binds to these proteins and is visible on a scan, helping doctors understand protein presence in the brain.
Eligible Conditions
- Dementia
- Shy-Drager syndrome
- 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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Quantitative analysis of [18F]UCB-2897 brain PET scans
Safety Outcome Measures
Whole-body Biodistribution Outcome Measures
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
18 Previous Clinical Trials
460 Total Patients Enrolled
1 Trials studying Dementia
30 Patients Enrolled for Dementia
David Russell, MD, Ph.DPrincipal InvestigatorPrincipal Investigator
Joyce Gibbons, PA-CPrincipal InvestigatorSub-Investigator
Amy Knorr, MDPrincipal InvestigatorSub-Investigator