NCT05542953

[18F]APN-1607 PET in Subjects With AD Compared to HC

A Phase 3, Multicenter Study of [18F]APN-1607 Positron Emission Tomography in Subjects With Alzheimer's Disease Compared to Healthy Subjects

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 230 (actual)
• Sponsor: APRINOIA Therapeutics · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Accepted

Summary

The overall objective of this study is to compare the overall pattern of \[18F\]APN-1607 uptake in subjects with MCI, subjects with AD dementia, and healthy subjects.

Conditions

• Alzheimer's Disease
• Mild Cognitive Impairment Due to Alzheimer's Disease
• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	[18F]APN-1607	In this study, all patients will receive one injection of \[18F\]APN-1607, a PET radiopharmaceutical selective for fibrillar tau. For the injection, subjects will receive a target dose of 5-7 mCi IV as a bolus injection. \[18F\]APN-1607 injection will be followed by a 10 ml saline flush.

Timeline

• Start date: 2022-01-21
• Primary completion: 2023-12-25
• Completion: 2023-12-25
• First posted: 2022-09-16
• Last updated: 2025-09-08

Locations

1 site across 1 country: China