Evaluation of [18F]APN-1607 as a PET Biomarker

Phase 1

Completed

• Conditions: Progressive Supranuclear Palsy; Healthy Volunteers
• Interventions: Drug: [18F] APN-1607

• Registration Number: NCT05005819
• Lead Sponsor: Invicro

Brief Summary

The overall goal of this protocol is to evaluate \[18F\]APN-1607 as a PET radiotracer for measuring longitudinal change in tau pathology in participants with PSP.

Detailed Description

The overall goal of this protocol is to evaluate \[18F\]APN-1607 as a PET radiotracer for measuring longitudinal change in tau pathology in participants with PSP. The specific objectives are:

* To characterize and demonstrate the longitudinal progression of tau deposition in vivo in participants with PSP.

* To determine optimal PET analysis parameters for \[18F\]APN-1607 quantification.

* To characterize the stability of tau deposition in vivo over time in healthy volunteers (HVs).

* To evaluate consistency of \[18F\]APN-1607 quantification in characterizing tau deposition.

Study Timeline

• Study Start: 2021-05-25
• Study First Submitted: 2021-06-29
• Study First Submitted QC: 2021-08-12
• Study First Posted: 2021-08-16
• Primary Completion: 2024-01-09
• Study Completion: 2024-01-09
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[18F]APN-1607	[18F] APN-1607	Participants will receive an IV bolus injection of \[18F\]APN-1607, followed by PET brain imaging.

Primary Outcome Measures

Name	Time	Method
Change in standardized uptake value ratios (SUVRs) of regional [18F]APN-1607.	72 weeks	The within-group change in standardized uptake value ratios (SUVRs) of regional \[18F\]APN-1607 binding within a priori defined cortical and subcortical brain regions from Baseline to Week 36 and Week 72.

Trial Locations

Locations (1)

Invicro; 🇺🇸 New Haven, Connecticut, United States