NCT02016560

Analysis of 18F-AV-1451 PET Imaging in Cognitively Healthy, MCI, and AD Subjects

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 383 (actual)
• Sponsor: Avid Radiopharmaceuticals · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Accepted

Summary

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).

Detailed description

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.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	florbetapir F 18
DRUG	Flortaucipir F18
PROCEDURE	Brain PET Scan	positron emission tomography (PET) scan of the brain

Timeline

• Start date: 2013-12-01
• Primary completion: 2017-07-28
• Completion: 2017-07-28
• First posted: 2013-12-20
• Last updated: 2020-09-22
• Results posted: 2020-08-24

Locations

27 sites across 1 country: United States