Imaging of Brain Amyloid Plaques in the Aging Population
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| ClinicalTrials.gov Identifier: NCT00950430 |
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Recruitment Status :
Enrolling by invitation
First Posted : July 31, 2009
Last Update Posted : October 7, 2021
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Sponsor:
Mayo Clinic
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Val Lowe, Mayo Clinic
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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 |
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 (Clinical Trial) |
| Estimated Enrollment : | 5000 participants |
| Allocation: | N/A |
| 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
MedlinePlus Genetics related topics:
Alzheimer disease
CHMP2B-related frontotemporal dementia
Frontotemporal dementia with parkinsonism-17
Dementia with Lewy bodies
Inclusion body myopathy with early-onset Paget disease and frontotemporal dementia
GRN-related frontotemporal lobar degeneration
| 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)
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Primary Outcome Measures :
- To understand the predictive ability of PiB PET imaging for neurodegenerative diseases. [ Time Frame: up to 20 years ]
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 ]
- 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 ]
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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.
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
| 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 |
Additional Information:
| Responsible Party: | Val Lowe, Consultant - Diagnostic Radiology, Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT00950430 |
| 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: | October 7, 2021 |
| Last Verified: | September 2021 |
Keywords provided by Val Lowe, Mayo Clinic:
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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 Lewy Body Disease Dementia, Vascular Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders Proteostasis Deficiencies |
Metabolic Diseases Frontotemporal Lobar Degeneration TDP-43 Proteinopathies Aphasia Speech Disorders Language Disorders Communication Disorders Neurobehavioral Manifestations Neurologic Manifestations Parkinsonian Disorders Basal Ganglia Diseases Movement Disorders Synucleinopathies Cerebrovascular Disorders Intracranial Arteriosclerosis |