Imaging of Brain Amyloid Plaques in the Aging Population

Status: Enrolling by invitation
Study State Date: April 2008
Primary Completion Date: Anticipated April 2018
Study Type: Interventional
Study Design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Phase: Phase 4

Mayo Clinic
National Institute on Aging (NIA)
Information By: Mayo Clinic
Trial Identifier: NCT00950430
Official Title: Brain Amyloid Imaging With Pittsburgh Compound B in Normal Aging, Mild Cognitive Impairment, and Dementia

Description:  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.

+ Additional Objectives Detail

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.

Accepts Healthy Volunteers?: Accepts Healthy Volunteers
Enrollment: 2500 Anticipated
Minimum Age: 40 Years
Maximum Age: N/A
Gender(s): Both
Additional Criteria:  Inclusion Criteria: - Age 40-100 - 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 - Claustrophobic patients unable to tolerate the scans - Standard safety exclusionary criteria for MRI such as metallic foreign bodies, pacemaker, etc.

Alzheimer's Disease
Vascular Dementia
Alzheimer Disease
Dementia With Lewy Bodies
Frontotemporal Dementia
Dementia, Vascular
Lewy Body Disease
Pick Disease of the Brain
Aphasia, Primary Progressive
Drug: Pittsburgh Compound B (C-11 PiB)
Drug: F-18 FDG
Primary Outcome Measures:
To understand the predictive ability of PiB PET imaging for neurodegenerative diseases.
Time Frame: up to 20 years
Safety Issue: No

Secondary Outcome Measures:
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.
Time Frame: up to 20 years
Safety Issue: No

To identify the relationship between amyloid burden and the risk of progression from CN at baseline to MCI.
Time Frame: up to 20 years
Safety Issue: No

To identify the relationship between amyloid burden and the risk of progression from MCI at baseline to dementia.
Time Frame: up to 20 years
Safety Issue: No

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.
Time Frame: up to 20 years
Safety Issue: No

Patient Groups:
Assigned Interventions:

PiB PET, FDG PET: Experimental
Drug: Pittsburgh Compound B (C-11 PiB)
C-11 PiB, 10-20 mCi every 6 months for up to 20 years; PET imaging agent to identify brain amyloid.

Drug: F-18 FDG
F-18 FDG, 10-20 mCi every 6 months for up to 20 years; PET imaging agent to identify brain amyloid.


Principal Investigator: Val Lowe, M.D., Mayo Clinic

Study Locations:
+ Show All 1 Study Locations

United States, Minnesota
Mayo Clinic 
Rochester, Minnesota, United States

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