Brain Amyloid Imaging With Pittsburgh Compound B in Normal Aging, Mild Cognitive Impairment, and Dementia
Trial Snapshot
- Phase
- Phase 4
- Status
- Enrolling By Invitation
- Sponsor
- Mayo Clinic
- Enrollment
- 8,000
- Locations
- 2
- Primary Endpoint
- To understand the predictive ability of PiB PET imaging for neurodegenerative diseases.
Study Overview
Brief Summary
This is a prospective, open label, non-therapeutic, diagnostic imaging study. The purpose of this study is to utilize Pittsburgh Compound B positron emission imaging (PiB PET) to ascertain the relationship between change in amyloid burden over time, and concurrent change in clinical status.
Detailed Description
Identification of risk factors and biomarkers of neurodegenerative disease is essential in caring for the growing numbers of elderly. Imaging biomarkers provide non-invasive ways to look at brain function. A new PET imaging agent, Pittsburgh Compound B (PiB), that identifies brain amyloid is an exciting development in brain imaging that needs to be studied. We plan to study this imaging technique in normal volunteers and patients with a variety of neurodegenerative diseases to determine its utility. Long term followup of these subjects will allow us to understand the predictive ability of this new test.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age 30-100
- •Subjects who have completed or are scheduled to undergo the neurological evaluation procedures in the Mayo Clinic Study of Aging, Mayo ADRC, or Mayo neurodegenerative disease clinics.
Exclusion Criteria
- •Subjects unable to lie down without moving for 10 minutes
- •Women who are pregnant or cannot stop breast feeding for 24 hours at the time of scanning
- •Claustrophobic patients unable to tolerate the scans
- •Standard safety exclusionary criteria for MRI such as metallic foreign bodies, pacemaker, etc.
Arms & Interventions
PiB PET, FDG PET, Tau PET
Intervention: Pittsburgh Compound B (C-11 PiB) (Drug)
PiB PET, FDG PET, Tau PET
Intervention: F-18 FDG (Drug)
PiB PET, FDG PET, Tau PET
Intervention: Tau (18-F-AV-1451) (Drug)
Outcomes
Primary Outcomes
To understand the predictive ability of PiB PET imaging for neurodegenerative diseases.
Time Frame: up to 20 years
Secondary Outcomes
- To identify the relationship between amyloid burden and the risk of progression from CN at baseline to MCI.(up to 20 years)
- Using PiB-PET, to ascertain cross-sectionally the magnitude and the spatial distribution of amyloid deposition in the brain in subjects who are clinically classified as CN, MCI, and demented.(up to 20 years)
- To identify the relationship between amyloid burden and the risk of progression from MCI at baseline to dementia.(up to 20 years)
- To measure longitudinal change in amyloid burden and cognition and characterize the correlation between change on serial PiB-PET measures vs. FDG measures and concurrent change on continuous measures of cognitive performance.(up to 20 years)
Investigators
Val Lowe
Consultant - Diagnostic Radiology
Mayo Clinic