NCT01153607

Evaluation of the Diagnostic Potential of BAY1006578 in Probable Alzheimers Disease Patients Versus Healthy Volunteers and Radiation Dosimetry of BAY1006578 in Healthy Volunteers

Open-label, Non-randomized, Multicenter Positron Emission Tomography (PET) Imaging Study to Evaluate a Single Dose of BAY1006578 for Its Diagnostic Potential in Discriminating Patients With Probable Alzheimers Disease From Healthy Volunteers and to Evaluate the Radiation Dosimetry of a Single Dose of BAY1006578 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Life Molecular Imaging SA · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

Summary

PET (positron emission tomography) imaging with BAY1006578 for investigation of diagnostic potential in probable Alzheimer Disease patients versus healthy volunteers and radiation dosimetry in healthy volunteers.

Conditions

• Diagnostic Imaging

Interventions

Type	Name	Description
DRUG	BAY1006578	Alzheimer Disease patients: Single intravenous bolus injection of 250 MBq BAY1006578 on day one of the treatment period, PET
DRUG	BAY1006578	Healthy volunteers for brain imaging: Single intravenous bolus injection of 250 MBq BAY1006578 on day one of the treatment period, PET
DRUG	BAY1006578	Healthy volunteers for whole body imaging: Single intravenous bolus injection of 190 MBq BAY1006578, whole body PET for evaluation of effective dose, kinetics of BAY1006578 in blood

Timeline

• Start date: 2010-06-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2010-06-30
• Last updated: 2013-01-21

Locations

2 sites across 2 countries: Finland, Sweden