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Imaging of Brain Amyloid Plaques in the Aging Population

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Mayo Clinic

Status and phase

Invitation-only
Phase 4

Conditions

Alzheimer's Disease
Frontotemporal Dementia
Vascular Dementia
Dementia With Lewy Bodies

Treatments

Drug: Tau (18-F-AV-1451)
Drug: F-18 FDG
Drug: Pittsburgh Compound B (C-11 PiB)

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00950430
08-005553
U01AG006786 (U.S. NIH Grant/Contract)
R01AG011378 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

8,000 estimated patients

Sex

All

Ages

30 to 100 years old

Volunteers

Accepts Healthy Volunteers

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 at the time of scanning
  • Claustrophobic patients unable to tolerate the scans
  • Standard safety exclusionary criteria for MRI such as metallic foreign bodies, pacemaker, etc.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

8,000 participants in 1 patient group

PiB PET, FDG PET, Tau PET
Experimental group
Treatment:
Drug: F-18 FDG
Drug: Pittsburgh Compound B (C-11 PiB)
Drug: Tau (18-F-AV-1451)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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