PET Imaging of Brain Amyloid in Normal Pressure Hydrocephalus

General Electric (GE)

Status and phase: Completed; Phase 3

Conditions: Normal Pressure Hydrocephalus

Treatments: Drug: [18F] Flutemetamol

Study type: Interventional

Funder types: Industry

Identifiers

NCT01053312

GE 067-008

Details and patient eligibility

About

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).

Enrollment: 7 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

1 flutemetamol

Experimental group

Treatment:

Drug: [18F] Flutemetamol