Proof of Mechanism Study to Evaluate Binding of Alfa-synuclein

Parkinson Disease Clinical Trial

Official title: Proof of Mechanism Study to Evaluate Binding of Alfa-synuclein by [18F]UCB-2897 in Participants With Parkinson's Disease or Multi-system Atrophy

Status Recruiting

Clinical Trial Summary

The overall goal of this protocol is to:

Evaluate [18F]UCB-2897 as an α-synuclein targeted radiopharmaceutical.

The primary objective is:

• Confirm a specific α -synuclein signal with [18F]UCB-2897 in participants with PD and/or MSA relative to healthy volunteers

Secondary and exploratory objectives are:

• Determine the safety and tolerability of microdose [18F]UCB-2897

• Evaluate preliminary dosimetry of [18F]UCB-2897

Additional exploratory objectives are:

• Determine the pharmacokinetics / metabolism of [18F]UCB-2897

• Determine the optimal imaging protocol for [18F]UCB-2897

Clinical Trial Description

This is a first in human [FiH], open-label study to assess the imaging characteristics, kinetics, and safety of [18F]UCB-2897 in participants with MSA, participants with PD, and healthy participants. Up to 2 participants with MSA, up to 8 participants with PD, and up to 5 healthy volunteers will be enrolled from the available database at Invicro, through advertising, and through physician referral. Participants will be enrolled in 2 parts that may be run concurrently: Part A (up to 2 participants with PD and up to 2 participants with MSA) and Part B (up to 6 participants with PD and up to 5 healthy volunteers). Data will be reviewed on an ongoing basis throughout the study, at least at the end of Part A.

All participants will attend the following (with exceptions noted):

• Screening

• [18F]UCB-2897 positron emission tomography (PET) Imaging Visit (including brain PET imaging or whole-body PET imaging)

• Follow-up Phone Call

• Amyloid PET Imaging Visit (not performed for all participants)

• DaTscan single photon emission computed tomography (SPECT) Imaging Visit (not performed for all participants)

During Screening, participants will undergo assessments to confirm study eligibility, including an MRI scan (unless a previously acquired approved scan is available) for participants who will have brain PET imaging. Participants with MSA and PD will also have a DaTscan SPECT scan during Screening (unless a previously acquired approved scan is available).

Within 4 weeks of the start of Screening, participants will attend a [18F]UCB-2897 PET Imaging Visit. Participants with MSA, participants with PD, and up to 2 healthy volunteers will undergo brain PET imaging, including one injection of [18F]UCB-2897, one brain PET scan lasting up to 2 hours, and arterial blood sampling. If the participant does not consent to arterial blood sampling or the study team deems it appropriate based on emerging data, venous blood samples may be collected in lieu of arterial blood samples. Brain PET imaging and blood data will be used to assess α-synuclein binding by [18F]UCB-2897. Up to 3 healthy volunteers will undergo whole-body PET imaging assessments, including one injection of [18F]UCB-2897, a series of whole-body PET scans lasting up to 6 hours, and urine collection. Whole-body PET imaging and urine samples will be assessed for a preliminary evaluation of [18F]UCB-2897 dosimetry. During PET imaging (both brain and whole-body), safety assessments will be performed to evaluate the safety and tolerability of [18F]UCB-2897, including ECGs, physical and neurological examinations, clinical laboratory samples, and vital sign measurements.

A Follow-up Phone Call to the participant will be conducted 4 days (± 2 days) post-injection of [18F]UCB-2897 to confirm participant well-being and to collect information about any new adverse events (AEs).

If the study team considers that further investigation on potential cross-binding with beta (β)-amyloid is needed, participants with MSA or PD will attend an Amyloid PET Imaging Visit and have amyloid PET imaging performed with an approved amyloid tracer (unless a previously acquired approved scan is available). Additionally, if needed for further interpretation of data, healthy volunteers who received brain PET imaging may have a DaTscan SPECT scan (unless a previously acquired approved scan is available).

When the participant completes his or her final study visit, the participant will be formally released from the study. ;

Related Conditions & MeSH terms

• Atrophy
• Healthy Volunteer
• Multiple System Atrophy
• Parkinson Disease
• Shy-Drager Syndrome

• NCT number: NCT05274568
• Study type: Interventional
• Source: Invicro
• Contact: David Placzek
• Phone: 203-401-4300
• Email: recruitment@invicro.com
• Status: Recruiting
• Phase: Phase 1
• Start date: January 31, 2022
• Completion date: December 31, 2022