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UAB Alzheimer's Disease Center Core Cohort - Imaging Substudy (PiB ADC)

Primary Purpose

Alzheimer Disease

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
[C-11]PiB-PET/MRI
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Alzheimer Disease

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

- 1. Enrollment in the UAB-ADC study under a separate IRB-approved research protocol (IRB-300000169).

2. Negative urine or serum B-hCG test within 2 days of [C-11]PiB administration in women of child bearing potential. Women who are post-menopausal with at least 1 year since last menses or documented surgical sterilization will not require pregnancy testing.

Exclusion Criteria:

  1. Meets any exclusion criteria for the UAB-ADC study (IRB-300000169).
  2. Inability or contraindication for undergoing MRI and/or PET imaging
  3. Inability to participate in the imaging studies due to severity of dementia

Sites / Locations

  • University of Alabama at Birmingham Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

[C-11]PiB-PET/MRI

Arm Description

All participants in this study will undergo an amyloid-PET imaging using the tracer [C-11]PiB with a simultaneous PET/MRI system. The [C-11]PiB dosage is 300-670 MBq (8 - 18 mCi) given intravenously, and the PET/MRI imaging time is approximately 60 min.

Outcomes

Primary Outcome Measures

Measurement of pathological beta-amyloid in the brain
The amount of pathological beta-amyloid in the brains of study participants will be measured with [C-11]PiB-PET/MRI using standardized uptake value ratios (SUVRs) derived from the PET images.

Secondary Outcome Measures

Full Information

First Posted
February 26, 2018
Last Updated
June 29, 2023
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT03503331
Brief Title
UAB Alzheimer's Disease Center Core Cohort - Imaging Substudy
Acronym
PiB ADC
Official Title
UAB Alzheimer's Disease Center Core Cohort - Imaging Substudy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 20, 2018 (Actual)
Primary Completion Date
April 1, 2026 (Anticipated)
Study Completion Date
April 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The primary objective of this study is to measure the concentration and the regional brain distribution of pathologic amyloid deposition using the PET tracer [C-11]PiB in participants in the UAB Alzheimer's Disease Center cohort. Assessment of interactions between race and vascular risk factors, brain amyloid levels measured with [C-11]PiB-PET, and cognitive status will be the primary outcome of this imaging study.
Detailed Description
The primary objective of this study is to measure the concentration and the regional brain distribution of pathologic amyloid deposition using the PET tracer [C-11]PiB in participants in the UAB-ADC cohort. The amount and distribution of [C-11]PiB in the brain will be correlated to demographic, clinical, genetic, and biospecimen data acquired through the separate ongoing UAB-ADC study. Assessment of interactions between race and vascular risk factors, brain amyloid levels measured with [C-11]PiB-PET, and cognitive status will be the primary outcome of this imaging study. As a secondary aim, the investigators will assess the ability of the early flow frames from [C-11]PiB-PET and brain volumetric measurements with MRI to serve as a marker of neuronal injury and to predict cognitive status in conjunction with the amyloid-PET results.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Brain amyloid PET levels will be measured with the PET tracer [C-11]PiB in all study participants.
Masking
None (Open Label)
Allocation
N/A
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
[C-11]PiB-PET/MRI
Arm Type
Experimental
Arm Description
All participants in this study will undergo an amyloid-PET imaging using the tracer [C-11]PiB with a simultaneous PET/MRI system. The [C-11]PiB dosage is 300-670 MBq (8 - 18 mCi) given intravenously, and the PET/MRI imaging time is approximately 60 min.
Intervention Type
Drug
Intervention Name(s)
[C-11]PiB-PET/MRI
Intervention Description
All study participants will undergo brain imaging with [C-11]PiB-PET/MRI. [C-11]PiB is a PET imaging agent used primarily to measure the amount of abnormal protein (called beta-amyloid) in the brain. The investigator will also use this tracer to evaluate regional cerebral blood flow.
Primary Outcome Measure Information:
Title
Measurement of pathological beta-amyloid in the brain
Description
The amount of pathological beta-amyloid in the brains of study participants will be measured with [C-11]PiB-PET/MRI using standardized uptake value ratios (SUVRs) derived from the PET images.
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: - 1. Enrollment in the UAB-ADC study under a separate IRB-approved research protocol (IRB-300000169). 2. Negative urine or serum B-hCG test within 2 days of [C-11]PiB administration in women of child bearing potential. Women who are post-menopausal with at least 1 year since last menses or documented surgical sterilization will not require pregnancy testing. Exclusion Criteria: Meets any exclusion criteria for the UAB-ADC study (IRB-300000169). Inability or contraindication for undergoing MRI and/or PET imaging Inability to participate in the imaging studies due to severity of dementia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
April Riddle
Phone
2059346504
Email
ariddle@uabmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Marianne Vetrano
Phone
205-934-4080
Email
mvetrano@uabmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan McConathy, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham Medical Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan McConathy, MD
Phone
205-996-7115
Email
jmcconathy@uabmc.edu
First Name & Middle Initial & Last Name & Degree
Jonathan McConathy, MD, PhD
First Name & Middle Initial & Last Name & Degree
Bag Asim, MD
First Name & Middle Initial & Last Name & Degree
Bhambhvani Pradeep, MD
First Name & Middle Initial & Last Name & Degree
Choudhary Gagandeep, MD
First Name & Middle Initial & Last Name & Degree
Geldmacher David, MD
First Name & Middle Initial & Last Name & Degree
Lapi Suzanne, PhD
First Name & Middle Initial & Last Name & Degree
Jeffers Charlotte Denise, RPh
First Name & Middle Initial & Last Name & Degree
Natelson Marissa, MD
First Name & Middle Initial & Last Name & Degree
Roberson Erik, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

UAB Alzheimer's Disease Center Core Cohort - Imaging Substudy

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