Positron Emission Tomography Imaging of Brain Amyloid in Normal Pressure Hydrocephalus

General Electric (GE)

Status and phase: Terminated; Phase 3

Conditions: Normal Pressure Hydrocephalus

Treatments: Drug: [18F]Flutemetamol

Study type: Interventional

Funder types: Industry

Identifiers

NCT01092546

GE-067-009

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

12 participants in 1 patient group

Arm 1

Experimental group

Treatment:

Drug: [18F]Flutemetamol