Imaging of Brain Amyloid Plaques in the Aging Population

Phase 4

• Conditions: Vascular Dementia; Alzheimer's Disease; Dementia With Lewy Bodies; Frontotemporal Dementia
• Interventions: Drug: Pittsburgh Compound B (C-11 PiB); Drug: F-18 FDG; Drug: Tau (18-F-AV-1451)

• Registration Number: NCT00950430
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2009-07-29
• Study First Submitted QC: 2009-07-30
• Study First Posted: 2009-07-31
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-17
• Last Update Posted: 2024-07-19
• Primary Completion: 2027-06
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 8000

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PiB PET, FDG PET, Tau PET	Pittsburgh Compound B (C-11 PiB)	-
PiB PET, FDG PET, Tau PET	Tau (18-F-AV-1451)	-
PiB PET, FDG PET, Tau PET	F-18 FDG	-

Primary Outcome Measures

Name	Time	Method
To understand the predictive ability of PiB PET imaging for neurodegenerative diseases.	up to 20 years

Secondary Outcome Measures

Name	Time	Method
To identify the relationship between amyloid burden and the risk of progression from CN at baseline to MCI.	up to 20 years
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 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

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States