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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

Brief 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.

Detailed Summary: 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.
Sponsor: New York State Psychiatric Institute

Current Primary Outcome: Changes in amyloid plaque load in the brain of the course of 3 years [ Time Frame: Amyloid plaque load in the brain will be measured at baseline and again 3 years later ]

Positron emission tomography (PET) and x-ray computed tomography (CT) brain imaging using Florbetaben is considered an in vivo measure of brain amyloid plaque load. We will obtain PET/CT scans on a selection of participants who will be selected on the basis of change in plasma levels of amyloid beta to validate amyloid beta as a viable biomarker for late onset Alzheimer's disease. Participants will receive scans in a 2010-2012 assessment wave, and then again in a 2014-2015 assessment wave to determine whether increased uptake in the brain correlates with declining levels of plasma amyloid beta


Original Primary Outcome: Brain amyloid plaque load [ Time Frame: Change from baseline at year 3 ]

Positron emission tomography (PET) brain imaging using BAY 94-9172 PET/CT is considered an in vivo measure of brain amyloid plaque load. We will obtain BAY 04-9172 PET/CT on a selection of ongoing WHICAP participants who will be selected on the basis of change in plasma Aβ levels to validate plasma Aβ as a viable biomarker for late onset Alzheimer's disease. Approximately 200 participants will receive BAY 94-9172 PET/CT in a 2010-2012 assessment wave, and then again in a 2014-2015 assessment wave to determine whether increased uptake in the brain correlates with declining levels of plasma Aβ.


Current Secondary Outcome:

Original Secondary Outcome:

Information By: New York State Psychiatric Institute

Dates:
Date Received: October 14, 2010
Date Started: December 2010
Date Completion: January 2018
Last Updated: March 27, 2017
Last Verified: March 2017