Positron Emission Tomography (PET) Imaging of Brain Amyloid Compared to Post-Mortem Levels

General Electric (GE)

Status and phase: Completed; Phase 3

Conditions: Brain Fibrillarab Levels

Treatments: Drug: [18F] Flutemetamol

Study type: Interventional

Funder types: Industry

Identifiers

NCT01165554

GE-067-007

Details and patient eligibility

About

To determine the level of association between quantitative regional estimates of brain uptake of [18F]flutemetamol and quantitative immunohistochemical regional estimates of brain levels of amyloid estimated from post-mortem analysis of corresponding brain tissue samples.

Enrollment: 203 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The subject has a short life expectancy (approximately 1 year or less) as estimated by the Investigator.
• The subject is 70 years of age or older if cognitively normal, or 55 years of age or older if terminal because of dementia.
• The subject's general health is adequate to undergo the study procedures.

Exclusion criteria

• The subject has a contraindication for PET.
• The subject has a known or suspected hypersensitivity/allergy to [18F]flutemetamol or to any of the excipients.
• The subject is unable to tolerate or cooperate with study procedures.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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203 participants in 1 patient group

[18F] Flutemetamol

Experimental group

Treatment:

Drug: [18F] Flutemetamol