Imaging of Brain Amyloid Plaques in the Aging Population

Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00950430
• Other study ID #: 08-005553
• Secondary ID: U01AG006786R01AG
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: April 2008
• Est. completion date: June 2024

Study information

• Verified date: June 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 8000
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Aphasia, Primary Progressive
• Dementia
• Dementia With Lewy Bodies
• Dementia, Vascular
• Frontotemporal Dementia
• Lewy Body Disease
• Pick Disease of the Brain
• Vascular Dementia

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To understand the predictive ability of PiB PET imaging for neurodegenerative diseases.		up to 20 years
Secondary	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
Secondary	To identify the relationship between amyloid burden and the risk of progression from CN at baseline to MCI.		up to 20 years
Secondary	To identify the relationship between amyloid burden and the risk of progression from MCI at baseline to dementia.		up to 20 years
Secondary	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

External Links

•   Mayo Clinic Clinical Trials