Clinical trial NCT00950430: Imaging of Brain Amyloid Plaques in the Aging Population
Official title: Brain Amyloid Imaging With Pittsburgh Compound B in Normal Aging, Mild Cognitive Impairment, and Dementia
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE4
Conditions: Alzheimer's Disease
Dementia With Lewy Bodies
Frontotemporal Dementia
Vascular Dementia
Keywords: Imaging
PET
PiB
FDG
MCI
Dementia
Alzheimer's Disease
Brain Amyloid
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2009-07-31
Enrollment: 8000
Sex: ALL
Minimum age (years): 30
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To understand the predictive ability of PiB PET imaging for neurodegenerative diseases.
timeFrame: up to 20 years
Secondary outcomes:
measure: 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.
timeFrame: up to 20 years
measure: To identify the relationship between amyloid burden and the risk of progression from CN at baseline to MCI.
timeFrame: up to 20 years
measure: To identify the relationship between amyloid burden and the risk of progression from MCI at baseline to dementia.
timeFrame: up to 20 years
measure: 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.
timeFrame: up to 20 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Val Lowe, M.D.
role: PRINCIPAL_INVESTIGATOR
References: