A Phase II Trial of 18F-AV-45 Positron Emission Tomography (PET) Imaging in Healthy Volunteers, Patients With Mild Cognitive Impairment (MCI) and Patients With Alzheimer's Disease (AD)
Completed
Avid Radiopharmaceuticals
Phase 2
2008-06-01
Evaluate 18F-AV-45 positron emission tomography (PET) imaging for distinguishing healthy
control subjects, from subjects with Alzheimer's disease (AD) or Mild cognitive impairment
(MCI).
Phase III Study of the Correlation Between Florbetapir F18 PET Imaging and Amyloid Pathology in the Brain
Completed
Avid Radiopharmaceuticals
Phase 3
2008-12-01
The study is designed to test the relationship between measurements of brain amyloid using
florbetapir F 18 PET imaging and true levels of amyloid by dissection of the brain at
autopsy. Amyloid in the brain is a key feature of Alzheimer's Disease (AD).
Observational Study of Cognitive Outcomes for Subjects Who Have Had Prior PET Amyloid Imaging With Florbetapir F 18 (18F-AV-45)
Completed
Avid Radiopharmaceuticals
Phase 2
2009-01-01
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.
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