Measuring Brain Amyloid Plaque Load in Older Adults Using BAY 94-9172

Late Onset Alzheimer Disease Clinical Trial

Official title: BAY 94-9172 PET/CT in Cognitively Normal Older Adults, Older Adults With Mild Cognitive Impairment, and Older Adults With Alzheimer's Disease

Status Completed

Clinical Trial Summary

The overall goal of this project is to establish and validate biomarkers associated with the risk and progression of late onset Alzheimer's disease, mild cognitive impairment and cognitive decline. The investigators will use baseline and longitudinal measurements of plasma amyloid beta-40 and amyloid beta-42 to investigate the risk of developing mild cognitive impairment and late onset Alzheimer's disease, as well as the rates of cognitive decline and Alzheimer's disease progression. Participants will be selected on the basis of change in plasma amyloid beta levels over prior assessment intervals. The purpose of the study is to examine whether brain amyloid plaque load, which will be measured with positron emission tomography and x-ray computed tomography brain imaging using Florbetaben from Bayer, varies as a function of change in plasma levels of amyloid beta. The driving hypothesis of the study is that high plasma levels of amyloid beta are an antecedent indicator of increased risk of cognitive decline, mild cognitive impairment, and incident late onset Alzheimer's disease, and that declining plasma levels of amyloid beta are associated with the onset of cognitive decline. Further, high plasma levels of amyloid beta are related to increased levels of amyloid beta in the brain as measured by positron emission tomography positivity, and the specific pattern of positron emission tomography positivity and a decline in plasma amyloid beta over time are associated with the onset of cognitive decline associated with late onset Alzheimer's disease.

Clinical Trial Description

This project is a sub-study of the Washington Heights-Inwood Community Aging Project, which is a multidisciplinary, epidemiological study of Alzheimer's disease and related neurodegenerative disorders. We will obtain positron emission tomography scans and simultaneous x-ray computed tomography scans using Florbetaben from Bayer on a selection of ongoing participants who will be selected on the basis of change in plasma levels of amyloid beta over time. Approximately 200 participants will receive scans beginning in 2009 and in the 2010-2012 assessment wave and then again in a 2014-2015 assessment wave. Our intention is to examine whether uptake of Florbetaben in the brain varies as a function of previous history of change in plasma levels of amyloid beta in order to validate plasma amyloid beta as a viable biomarker for late onset Alzheimer's disease. ;

Related Conditions & MeSH terms

• Alzheimer Disease
• Late Onset Alzheimer Disease

• NCT number: NCT01222351
• Study type: Interventional
• Source: New York State Psychiatric Institute
• Status: Completed
• Phase: N/A
• Start date: December 2010
• Completion date: October 22, 2014