The Feasibility of Florbetapir Quantitation in Europe

Avid Pharmaceuticals

Status and phase: Completed; Phase 4

Conditions: Alzheimer's Disease

Treatments: Drug: Florbetapir (18F)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02107599

18F-AV-45-QP02

Details and patient eligibility

About

This study will evaluate whether the addition of quantitation as an adjunct to visual interpretations significantly improves the accuracy of Amyvid scan interpretation.

Enrollment: 96 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Readers have undergone Amyvid reader training
• Readers have not more than minimal experience with quantitation of amyloid PET scans

Exclusion criteria

• Readers have previously been trained to quantitate amyloid PET scans

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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96 participants in 1 patient group

Physician Readers

Experimental group

Description:

Physician readers will interpret Amyvid scans using qualitative analysis followed by the use of quantitation. No subjects will be exposed to Florbetapir(18F) as part of this study.

Treatment:

Drug: Florbetapir (18F)