Alzheimer's Disease Clinical Trial
Official title:
An Open Label, Multicenter Study, Evaluating the Safety and Imaging Characteristics of 18F-AV-1451 in Cognitively Healthy Volunteers, Subjects With Mild Cognitive Impairment, and Subjects With Alzheimer's Disease
A Phase 2/3 cross-sectional and longitudinal observational study evaluating imaging characteristics of flortaucipir in control subjects and patients with clinically defined MCI and AD dementia (AD).
This study was conducted in 2 phases: a Phase 2 Exploratory Phase and a Phase 3 Confirmatory
Phase. An overarching goal of the Exploratory Phase of this protocol was to further
investigate the pattern of flortaucipir PET imaging across the disease course, in cognitively
healthy subjects through patients with cognitive decline. To accomplish this goal, the
protocol investigated flortaucipir results in younger and older cognitively healthy normal
volunteers and patients with clinical diagnoses for cognitive complaints, ranging from MCI to
mild and moderate AD dementia. Additionally, the Exploratory Phase of this protocol
investigated relationships between flortaucipir PET signal and cognitive decline over the
18-month study period.
The second, Confirmatory Phase of the study was designed to provide independent validation of
the relationships observed in the exploratory analyses of the first phase. In particular, the
goal of the second phase was to confirm the relationship between flortaucipir uptake in the
brain as measured by PET signals at baseline and the subsequent rate of cognitive decline
observed over the 18-month longitudinal follow up.
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