Imaging of Brain Amyloid Plaques in the Aging Population

Study Description

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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

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	2500 participants
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 :	April 2008
Estimated Primary Completion Date :	April 2018
Estimated Study Completion Date :	April 2018

Arms and Interventions

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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.

Outcome Measures

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Primary Outcome Measures :

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

Secondary Outcome Measures :

1. 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 ]
2. To identify the relationship between amyloid burden and the risk of progression from CN at baseline to MCI. [ Time Frame: up to 20 years ]
3. To identify the relationship between amyloid burden and the risk of progression from MCI at baseline to dementia. [ Time Frame: up to 20 years ]
4. 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 ]

Eligibility Criteria

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Ages Eligible for Study:	30 Years to 100 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

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Locations

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Mayo Clinic

National Institute on Aging (NIA)

Investigators

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Val Lowe, Consultant - Diagnostic Radiology, Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00950430 History of Changes
Other Study ID Numbers:	08-005553; U01AG006786 ( U.S. NIH Grant/Contract ); R01AG011378 ( U.S. NIH Grant/Contract )
First Posted:	July 31, 2009
Last Update Posted:	April 13, 2018
Last Verified:	April 2018

Keywords provided by Val Lowe, Mayo Clinic:

Imaging; PET; PiB; FDG	MCI; Dementia; Alzheimer's Disease; Brain Amyloid

Additional relevant MeSH terms:

Alzheimer Disease; Dementia; Frontotemporal Dementia; Aphasia, Primary Progressive; Pick Disease of the Brain; Dementia, Vascular; Lewy Body Disease; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Frontotemporal Lobar Degeneration	TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases; Aphasia; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Cerebrovascular Disorders; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Leukoencephalopathies; Arteriosclerosis