Imaging of Brain Amyloid Plaques in the Aging Population

NCT ID: NCT00950430

Last Updated: 2025-06-06

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE4
• Total Enrollment: 8000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2027-06-30

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.

Conditions

Alzheimer's Disease; Dementia With Lewy Bodies; Frontotemporal Dementia; Vascular Dementia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

PiB PET, FDG PET, Tau PET

Group Type: EXPERIMENTAL

Pittsburgh Compound B (C-11 PiB)

Intervention Type: DRUG

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.

F-18 FDG

Intervention Type: DRUG

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.

Tau (18-F-AV-1451)

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Tau (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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Val Lowe

Consultant - Diagnostic Radiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Val Lowe, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

U01AG006786

Identifier Type: NIH

Identifier Source: secondary_id

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R01AG011378

Identifier Type: NIH

Identifier Source: secondary_id

View Link

08-005553

Identifier Type: -

Identifier Source: org_study_id