Test-retest Study With [18F]PI-2620 in PSP-RS and NDC

Phase 1

Completed

• Conditions: Progressive Supranuclear Palsy
• Interventions: Drug: [18F]-PI2620

• Registration Number: NCT05187546
• Lead Sponsor: Life Molecular Imaging GmbH

Brief Summary

The overall goal of this protocol is to evaluate the imaging characteristics of \[18F\]PI-2620 using positron emission tomography (PET) in patients with progressive supranuclear palsy, Richardson's syndrome (PSP-RS)

Detailed Description

The imaging characteristics of \[18F\]PI-2620 using positron emission tomography (PET) in patients with progressive supranuclear palsy, Richardson's syndrome (PSP-RS) will be evaluated by a) determining the test-retest variability of the \[18F\]PI-2620 binding parameters in brain of patients with PSP-RS and non-demented controls (NDC).

Study Timeline

• Study First Submitted: 2021-11-23
• Study First Submitted QC: 2022-01-07
• Study First Posted: 2022-01-12
• Study Start: 2022-03-10
• Primary Completion: 2024-02-29
• Study Completion: 2024-03-05
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Imaging characteristics of [18F]PI-2620 for detection of Tau deposition in the brain of PSP patients	[18F]-PI2620	All eligible PSP patients will receive two injections of the investigational imaging agent \[18F\]PI-2620: at a baseline PET imaging session and at a follow-up PET imaging session to evaluate the test-retest imaging characteristics. 10 PSP patients will be required to complete the study arm.
Imaging characteristics of [18F]PI-2620 for detection of Tau deposition in the brain of NDC subjects	[18F]-PI2620	All eligible non-demented control (NDC) subjects will receive two injections of the investigational imaging agent \[18F\]PI-2620: at a baseline PET imaging session and at a follow-up PET imaging session to evaluate the test-retest imaging characteristics. 5 NDC subjects will be required to complete the study arm.

Primary Outcome Measures

Name	Time	Method
Number of adverse events	The duration of the study for participants may be up to 74 days	Safety will be evaluated by collection of Adverse Events.
Test-retest variability of the [18F]PI-2620 binding parameters in brain of patients with PSP-RS and non-demented controls	The duration of the study for participants may be up to 74 days	Test-retest variability of \[18F\]PI-2620 accumulation will be analyzed using quantification

Secondary Outcome Measures

Name	Time	Method
Correlate radioligand binding in PSP-RS with clinical scales	The duration of the study for participants may be up to 74 days	Correlation of radioligand binding with clinical scales in PSP-RS will be analyzed
Compare quantification in terms if test-retest variability in PSP-RS and NDC	The duration of the study for participants may be up to 74 days	Comparison of quantification in terms of test-retest variability in PSP and NDC. The ability of \[18F\]PI-2620 to discriminate between PSP-RS and NDC will be assessed.

Trial Locations

Locations (1)

Ludwig-Maximilians-Universität München; 🇩🇪 Munich, Germany