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Imaging of Brain Amyloid Plaques in the Aging Population

Primary Purpose

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

Status

Enrolling by invitation

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Pittsburgh Compound B (C-11 PiB)

F-18 FDG

Tau (18-F-AV-1451)

About this trial

This is an interventional diagnostic trial for Alzheimer's Disease focused on measuring Imaging, PET, PiB, FDG, MCI, Dementia, Alzheimer's Disease, Brain Amyloid

Eligibility Criteria

30 Years - 100 Years (Adult, Older Adult)All SexesAccepts 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
Claustrophobic patients unable to tolerate the scans
Standard safety exclusionary criteria for MRI such as metallic foreign bodies, pacemaker, etc.

Sites / Locations

Mayo Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PiB PET, FDG PET, Tau PET

Arm Description

Outcomes

Primary Outcome Measures

To understand the predictive ability of PiB PET imaging for neurodegenerative diseases.

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.

To identify the relationship between amyloid burden and the risk of progression from CN at baseline to MCI.

To identify the relationship between amyloid burden and the risk of progression from MCI at baseline to dementia.

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.

Full Information

NCT ID

NCT00950430

First Posted

July 29, 2009

Last Updated

June 2, 2023

Sponsor

Mayo Clinic

Collaborators

National Institute on Aging (NIA)

1. Study Identification

Unique Protocol Identification Number

NCT00950430

Brief Title

Imaging of Brain Amyloid Plaques in the Aging Population

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Enrolling by invitation

Study Start Date

April 2008 (undefined)

Primary Completion Date

June 2024 (Anticipated)

Study Completion Date

June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

Collaborators

National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Imaging, PET, PiB, FDG, MCI, Dementia, Alzheimer's Disease, Brain Amyloid

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

8000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PiB PET, FDG PET, Tau PET

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Pittsburgh Compound B (C-11 PiB)

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

F-18 FDG

Intervention Description

Intervention Type

Drug

Intervention Name(s)

Tau (18-F-AV-1451)

Intervention Description

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.

Primary Outcome Measure Information:

Title

To understand the predictive ability of PiB PET imaging for neurodegenerative diseases.

Time Frame

up to 20 years

Secondary Outcome Measure Information:

Title

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

Title

To identify the relationship between amyloid burden and the risk of progression from CN at baseline to MCI.

Time Frame

up to 20 years

Title

To identify the relationship between amyloid burden and the risk of progression from MCI at baseline to dementia.

Time Frame

up to 20 years

Title

Time Frame

up to 20 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Val Lowe, M.D.

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

Links:

URL

https://www.mayo.edu/research/clinical-trials

Description

Mayo Clinic Clinical Trials

Learn more about this trial

Imaging of Brain Amyloid Plaques in the Aging Population

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