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

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.

Study Overview

• Status: Recruiting
• Conditions: Alzheimer Disease
• Intervention / Treatment: Drug: [C-11]PiB-PET/MRI

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.

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: April Riddle; Phone Number: 2059346504; Email: ariddle@uabmc.edu
• Study Contact Backup: Name: Marianne Vetrano; Phone Number: 205-934-4080; Email: mvetrano@uabmc.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Recruiting
      • University of Alabama at Birmingham Medical Center
      • Principal Investigator: Jonathan McConathy, MD, PhD
      • Contact: Jonathan McConathy, MD; Phone Number: 205-996-7115; Email: jmcconathy@uabmc.edu
      • Sub-Investigator: Bag Asim, MD
      • Sub-Investigator: Bhambhvani Pradeep, MD
      • Sub-Investigator: Choudhary Gagandeep, MD
      • Sub-Investigator: Geldmacher David, MD
      • Sub-Investigator: Lapi Suzanne, PhD
      • Sub-Investigator: Jeffers Charlotte Denise, RPh
      • Sub-Investigator: Natelson Marissa, MD
      • Sub-Investigator: Roberson Erik, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

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: [C-11]PiB-PET/MRI; 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.	Drug: [C-11]PiB-PET/MRI; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	5 years

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Jonathan McConathy, MD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2018
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: February 26, 2018
• First Submitted That Met QC Criteria: April 18, 2018
• First Posted (Actual): April 19, 2018

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 29, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: IRB-300001005

Drug and device information, study documents

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