Imaging of Brain Amyloid Plaques in the Aging Population

Brain Amyloid Imaging With Pittsburgh Compound B in Normal Aging, Mild Cognitive Impairment, and Dementia

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Frontotemporal Dementia; Vascular Dementia; Alzheimer's Disease; Dementia With Lewy Bodies
• Intervention / Treatment: Drug: Pittsburgh Compound B (C-11 PiB); Drug: F-18 FDG; Drug: Tau (18-F-AV-1451)

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 Type: Interventional
• Enrollment (Estimated): 8000
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years to 98 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To understand the predictive ability of PiB PET imaging for neurodegenerative diseases.	up to 20 years

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	up to 20 years
To identify the relationship between amyloid burden and the risk of progression from CN at baseline to MCI.	up to 20 years
To identify the relationship between amyloid burden and the risk of progression from MCI at baseline to dementia.	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.	up to 20 years

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Val Lowe, M.D., Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: July 29, 2009
• First Submitted That Met QC Criteria: July 30, 2009
• First Posted (Estimated): July 31, 2009

Study Record Updates

• Last Update Posted (Actual): June 6, 2023
• Last Update Submitted That Met QC Criteria: June 2, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Imaging; Alzheimer's Disease; PET; MCI; Dementia; FDG; Brain Amyloid; PiB
• Additional Relevant MeSH Terms: Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Metabolic Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Tauopathies; Language Disorders; Communication Disorders; Intracranial Arterial Diseases; Speech Disorders; Frontotemporal Lobar Degeneration; Intracranial Arteriosclerosis; Leukoencephalopathies; Aphasia; Dementia; Alzheimer Disease; Lewy Body Disease; Frontotemporal Dementia; Aphasia, Primary Progressive; Pick Disease of the Brain; Dementia, Vascular; Anti-Inflammatory Agents; Corticosterone
• Other Study ID Numbers: 08-005553; U01AG006786 (U.S. NIH Grant/Contract); R01AG011378 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No