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Imaging of Brain Amyloid Plaques in the Aging Population

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ClinicalTrials.gov Identifier: NCT00950430
Recruitment Status : Enrolling by invitation
First Posted : July 31, 2009
Last Update Posted : August 14, 2018
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Val Lowe, Mayo Clinic

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 2023
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine


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)
  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.


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, Older Adult)
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00950430


Locations
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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Val Lowe, M.D. Mayo Clinic
More Information
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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    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018

Keywords provided by Val Lowe, Mayo Clinic:
Imaging
PET
PiB
FDG
 MCI
Dementia
Alzheimer's Disease
Brain Amyloid

Additional relevant MeSH terms:
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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