NCT04141150

Evaluation of [18F]APN-1607 PET Uptake in Alzheimer's Disease Patients Compared With Healthy Subjects

A Phase 2, Multicenter Study of [18F]APN-1607 Positron Emission Tomography in Subjects With Alzheimer's Disease Compared to Healthy Subjects

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: APRINOIA Therapeutics, LLC · 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 MDAD, subjects with AD dementia, and healthy subjects.

Detailed description

The overall objective of this study is to compare the overall pattern of \[18F\]APN-1607 uptake in subjects with MDAD, subjects with AD dementia, and healthy subjects. The specific objectives are: * 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 determine the Braak stage equivalent reflected by \[18F\]APN-1607 uptake patterns. * To evaluate the relationship between regional measures of \[18F\]APN-1607 uptake and demographic characteristics, eg, age and gender; biological characteristics, eg, apolipoprotein E epsilon 4 (APOE4) carrier status and measures of Aβ burden; and clinical characteristics, eg, 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'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 7 mCi IV as a bolus injection. \[18F\]APN-1607 injection will be followed by a 10 ml saline flush.

Timeline

• Start date: 2022-03-22
• Primary completion: 2024-09-01
• Completion: 2025-02-01
• First posted: 2019-10-28
• Last updated: 2023-06-15

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study