NCT02792179

Evaluation of [18F]RO6958948 as Tracer for Positron Emission Tomography (PET) Imaging of Tau Burden in Alzheimer's Disease Participants

A Pilot Longitudinal Follow-Up Study of Tau Burden in The Brain of Subjects With Alzheimer's Disease Who Previously Participated in Study BP29409 Using [18F]RO6958948 Positron Emission Tomography

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 25 Years
• Healthy volunteers: Not accepted

Summary

This is a longitudinal, follow-up study in participants with Alzheimer's disease (AD) who previously participated in study BP29409 (NCT02187627). This study is designed to assess the longitudinal change of Tau pathology in the brain of participants with AD using the PET ligand \[18F\]RO6958948 and to assess the safety and tolerability of PET ligand.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	[18F]RO6958948	Radiolabeled low molecular weight compound, administered as single IV injection. The mass dose of \[18F\]RO6958948 injected will be less than or equal to (\</=) 10 micrograms (µg), injection volume \</=20 mL. Target injected activity for \[18F\]RO6958948 will be 370 megaBecquerel (MBq) (10 millicurie \[mCi\]).

Timeline

• Start date: 2016-07-19
• Primary completion: 2016-09-28
• Completion: 2016-09-28
• First posted: 2016-06-07
• Last updated: 2017-11-01

Locations

1 site across 1 country: United States