Imaging of Brain Amyloid Plaques in the Aging Population - Full Text View

Purpose

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	Intervention	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


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Brain Amyloid Imaging With Pittsburgh Compound B in Normal Aging, Mild Cognitive Impairment, and Dementia

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease CHMP2B-related frontotemporal dementia GRN-related frontotemporal dementia Perry syndrome frontotemporal dementia with parkinsonism-17 inclusion body myopathy with early-onset Paget disease and frontotemporal dementia

MedlinePlus related topics: Alzheimer's Disease Amyloidosis Dementia Diagnostic Imaging

Genetic and Rare Diseases Information Center resources: Familial Alzheimer Disease Pick's Disease Frontotemporal Dementia Frontotemporal Dementia, Ubiquitin-positive Primary Progressive Aphasia Semantic Dementia

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

To understand the predictive ability of PiB PET imaging for neurodegenerative diseases. [ Time Frame: up to 20 years ] [ Designated as safety issue: No ]

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. [ Time Frame: up to 20 years ] [ Designated as safety issue: No ]
To identify the relationship between amyloid burden and the risk of progression from CN at baseline to MCI. [ Time Frame: up to 20 years ] [ Designated as safety issue: No ]
To identify the relationship between amyloid burden and the risk of progression from MCI at baseline to dementia. [ Time Frame: up to 20 years ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]


Estimated Enrollment:	2500
Study Start Date:	April 2008
Estimated Study Completion Date:	April 2018
Estimated Primary Completion Date:	April 2018 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Arms

Assigned Interventions

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.

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.

Eligibility


Ages Eligible for Study:	30 Years to 100 Years (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00950430

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


Responsible Party:	Val Lowe, Consultant - Diagnostic Radiology, Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00950430 History of Changes
Other Study ID Numbers:	08-005553 U01AG006786 R01AG011378
Study First Received:	July 29, 2009
Last Updated:	January 13, 2016
Health Authority:	United States: Food and Drug Administration

Keywords provided by Mayo Clinic:


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

Additional relevant MeSH terms:


Alzheimer Disease Dementia Mild Cognitive Impairment 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	Cognition 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

ClinicalTrials.gov processed this record on September 30, 2016