NCT05043675

Clinical Evaluation of [18F]APN-1607 PET Uptake in Alzheimer's Disease Patients

Director of Nuclear Medicine Department

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Nanjing First Hospital, Nanjing Medical University · Academic / Other
• Sex: All
• Age: 45 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The overall objective of this study is to evaluate the overall pattern of \[18F\]APN-1607 uptake in subjects with AD dementia

Detailed description

* To expand the safety and tolerability profile for the administration of \[18F\]APN-1607 and PET scanning. * To assess regional patterns of \[18F\]APN-1607 uptake. * To evaluate the relationship between regional measures of \[18F\]APN-1607 uptake and measurements of AD disease severity, such as National Institute on Aging and Alzheimer's Association (NIA-AA) diagnosis, Mini-mental Status Exam (MMSE) score, and Alzheimer's Disease Assessment Scale-cognitive subscale (ADAScog).

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	[18F]APN-1607	Subjects will receive one injection of \[18F\]APN-1607 (0.1\~0.15mCi/Kg), a PET radiopharmaceutical selective for fibrillar tau. \[18F\]APN-1607 injection will be followed by a 10 ml saline flush.

Timeline

• Start date: 2021-09-10
• Primary completion: 2024-09-10
• Completion: 2024-09-10
• First posted: 2021-09-14
• Last updated: 2023-09-14

Locations

1 site across 1 country: China