Imaging of Brain Amyloid Plaques in the Aging Population

Sponsor

Mayo Clinic (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT00950430

Collaborator

National Institute on Aging (NIA) (NIH)

5,000

Enrollment

Location

Arm

180

Duration (Months)

27.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer's Disease Dementia With Lewy Bodies Frontotemporal Dementia Vascular Dementia	Drug: Pittsburgh Compound B (C-11 PiB) Drug: F-18 FDG Drug: Tau (18-F-AV-1451)	Phase 4

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

Anticipated Enrollment :

5000 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Brain Amyloid Imaging With Pittsburgh Compound B in Normal Aging, Mild Cognitive Impairment, and Dementia

Study Start Date :

Apr 1, 2008

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PiB PET, FDG PET, Tau PET	Drug: Pittsburgh 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. Drug: F-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. Drug: Tau (18-F-AV-1451) PIB PET scan, Tau PET scan and/or FDG PET scan 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.

Arm

Intervention/Treatment

Experimental: PiB PET, FDG PET, Tau PET

Drug: Pittsburgh 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.

Drug: F-18 FDG

Drug: Tau (18-F-AV-1451)

PIB PET scan, Tau PET scan and/or FDG PET scan 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.

Outcome Measures

Primary Outcome Measures

To understand the predictive ability of PiB PET imaging for neurodegenerative diseases. [up to 20 years]

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. [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 100 Years

Sexes Eligible for Study:

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
Claustrophobic patients unable to tolerate the scans
Standard safety exclusionary criteria for MRI such as metallic foreign bodies, pacemaker, etc.