Overview

Positron Emission Tomography Imaging of Brain Amyloid in Normal Pressure Hydrocephalus

Status:
Terminated
Trial end date:
2011-04-01
Target enrollment:
0
Participant gender:
All
Summary
To determine the level of association between the quantitative estimates of brain uptake of [18F]flutemetamol and the quantitative immunohistochemical and histochemistry estimates of amyloid levels in frontal lobe biopsy samples obtained from subjects during shunt placement for NPH.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
GE Healthcare
Collaborator:
i3 Statprobe
Treatments:
Flutemetamol
Criteria
Inclusion Criteria:

- The subject is at least 50 years of age.

- The subjects' general health is adequate to comply with study procedures.

- The subject has been scheduled for a shunt placement procedure for the treatment of
NPH.

Exclusion Criteria:

- The subject has a contraindication for MRI or PET.

- The subject is pregnant or lactating.

- The subject has a known or suspected hypersensitivity/allergy to [18F]flutemetamol or
to any of the excipients.

- The subject has participated in any clinical study using an investigational agent
within 30 days of dosing.