Imaging of Brain Amyloid Plaques in the Aging Population

Overview:

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

Sponsor(s):

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.

Eligibility:

Accepts Healthy Volunteers?: Accepts Healthy Volunteers
Enrollment: 1000 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.

Conditions:
Alzheimer's Disease
Vascular Dementia
Dementia With Lewy Bodies
Frontotemporal Dementia

Interventions:
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 10 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 10 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 10 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 10 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 10 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 10 years; PET imaging agent to identify brain amyloid.

Drug: F-18 FDG
F-18 FDG, 17 mCi +-10% every 6 months for up to 10 years; PET imaging agent to identify brain amyloid.

Location & Contacts:

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

Responsible Party:
Mayo Clinic (Val Lowe, M.D.)

Study Locations:
+ Show All 1 Study Locations

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

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