Imaging of Brain Amyloid Plaques in the Aging Population

Phase 4Enrolling By InvitationNCT00950430

Mayo Clinic8,000 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

8,000

Conditions

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

Interventions

Pittsburgh Compound B (C-11 PiB)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 FDGDRUG

Tau (18-F-AV-1451)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.

Eligibility

Sex: ALLMin age: 30 YearsMax age: 100 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Mayo Clinic

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

To understand the predictive ability of PiB PET imaging for neurodegenerative diseases.

Time frame: up to 20 years

Secondary Outcomes

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

To identify the relationship between amyloid burden and the risk of progression from CN at baseline to MCI.

Time frame: up to 20 years

To identify the relationship between amyloid burden and the risk of progression from MCI at baseline to dementia.

Time frame: 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.

Time frame: up to 20 years

Data from ClinicalTrials.gov

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