NCT03112096

A Phase I [18F]THK-5351 Positron Emission Tomography Study in Healthy Subjects and Alzheimer's Disease

A Phase I [18F]THK-5351 Positron Emission Computed Tomography Study of Biodistribution, Pharmacokinetics and Safety in Cognitively Healthy Subjects and Patients With Alzheimer's Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Asan Foundation · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This is a study to evaluate biodistribution, pharmacokinetics and safety of \[18F\]THK-5351 positron emission computed tomography in Cognitively Healthy Subjects and Patients with Alzheimer's Disease.

Detailed description

This is a study to evaluate biodistribution, pharmacokinetics and safety of \[18F\]THK-5351 positron emission computed tomography. Ten cognitively healthy subjects and 10 patients with Alzheimer's Disease will be enrolled. The primary outcome measures are to evaluate pharmacokinetics of \[18F\]THK-5351 Positron Emission Tomography imaging . Tracer biodistribution will be evaluated by global and regional standardized uptake value ratio of \[18F\]THK-5351 in the brain. Safety. For safety assessment, a physical examination, Electrocardiogram and vital signs will be performed at baseline and at the completion of all imaging to assess for interval change.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	[18F]THK-5351	Imaging for evaluating the biodistribution, pharmacokinetics and safety of abnormal tau protein in the brain

Timeline

• Start date: 2017-05-17
• Primary completion: 2018-08-31
• Completion: 2018-08-31
• First posted: 2017-04-13
• Last updated: 2020-12-14

Locations

1 site across 1 country: South Korea