PET Imaging of Brain Amyloid in Normal Pressure Hydrocephalus

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GE Healthcare
• Collaborator: i3 Statprobe
• Treatments: Flutemetamol

Criteria

Inclusion Criteria:

• The subject is 50 years old or older.

• The subject has had a frontal lobe cortical biopsy adequate for the detection and quantitation of amyloid.

• Informed consent has been signed and dated by the subject/and/or subjects' legally acceptable representative, if applicable, in accordance with local regulations.

Exclusion Criteria:

• The subject has a contraindication for MRI or PET.

• The subject has a known or suspected hypersensitivity/allergy to [18F]flutemetamol.

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