drugset / Trial / NCT00857506

Observational Study of Cognitive Outcomes for Subjects Who Have Had Prior PET Amyloid Imaging With Florbetapir F 18 (18F-AV-45)

NCT00857506

Phase 2 Completed 152 enrolled Avid Radiopharmaceuticals
NaSingle-groupSingle-blindDiagnostic

Summary

The primary objective of this protocol is to determine if brain amyloid imaged with florbetapir F 18 (18F-AV-45) PET scans is predictive of progressive cognitive impairment during the subsequent 36 months for groups of: normal controls, mild cognitive impairment and Alzheimer's disease. Hypothesis 1: The probability a subject will experience progressive cognitive impairment within 36 months of imaging will be greater in subjects whose 18F-AV-45 PET scan was rated amyloid positive compared to subjects whose PET scan was rated amyloid negative. The secondary objective is to determine the stability, over 36 months of a clinical diagnosis, of AD in patients with an amyloid positive 18F-AV-45 PET. Hypothesis 2: The diagnosis of AD will remain unchanged in patients whose PET scan were rated as amyloid positive.

Timeline

Start
2009-01
Primary completion
2011-12
Completion
2011-12

Drugs

EvaluationDrugModalityDoseRoute
Subject florbetapir F 18 Diagnostic / imaging agent 370 mbq Intravenous