NCT01053312

PET Imaging of Brain Amyloid in Normal Pressure Hydrocephalus

A Principal, Open-Label, Single Center Study to Validate the Detection of Cerebral Cortical Amyloid With Flutemetamol (18F) Injection in Subjects Previously Biopsied

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: GE Healthcare · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This study will determine the level of association between the quantitative estimates of brain uptake of \[18F\]flutemetamol and the quantitative immunohistochemical estimates of amyloid levels in biopsy samples previously obtained during shunt placement in patients who have normal pressure hydrocephalus (NPH).

Conditions

• Normal Pressure Hydrocephalus

Interventions

Type	Name	Description
DRUG	[18F] Flutemetamol	All subjects will receive an intravenous (IV) dose of \[18F\]flutemetamol (less than 10µg flutemetamol). The nominal activity of a single administration of \[18F\]flutemetamol will be 185 megabecquerels (MBq).

Timeline

• Start date: 2009-12-01
• Primary completion: 2010-07-01
• Completion: 2010-08-01
• First posted: 2010-01-21
• Last updated: 2012-06-11
• Results posted: 2012-06-05

Locations

1 site across 1 country: United States