Alzheimer's Disease, Dementia With Lewy Bodies, Frontotemporal Dementia, Vascular Dementia
Conditions
Keywords
Imaging, PET, PiB, FDG, MCI, Dementia, Alzheimer's Disease, Brain Amyloid
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.
Interventions
DRUGPittsburgh Compound B (C-11 PiB)
Repeat these scans approximately every 24-30 months for up to 10 years in those with all three PETs or 20 years in those with only PiB PET and FDG PET. A second PiB PET, TAU PET and/or FDG PET may be administered within a year if needed to ensure a completed exam for analysis in the rare case of exam failure or data loss.
DRUGF-18 FDG
Repeat these scans approximately every 24-30 months for up to 10 years in those with all three PETs or 20 years in those with only PiB PET and FDG PET. A second PiB PET, TAU PET and/or FDG PET may be administered within a year if needed to ensure a completed exam for analysis in the rare case of exam failure or data loss.
DRUGTau (18-F-AV-1451)
1. PIB PET scan, Tau PET scan and/or FDG PET scan 2. Repeat these scans approximately every 24-30 months for up to 10 years in those with all three PETs or 20 years in those with only PiB PET and FDG PET. A second PiB PET, TAU PET and/or FDG PET may be administered within a year if needed to ensure a completed exam for analysis in the rare case of exam failure or data loss. ECG will be performed on subjects who have not had previous ECG test at Mayo to rule out prolonged QT interval prior to PET TAU scan.
Sponsors
National Institute on Aging (NIA)
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 100 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To understand the predictive ability of PiB PET imaging for neurodegenerative diseases. | up to 20 years |
Secondary
| Measure | Time frame |
|---|---|
| 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 CN at baseline to MCI. | 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 |
Countries
United States
Outcome results
None listed