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Trial record 23 of 452 for:    Recruiting, Not yet recruiting, Available Studies | "Alzheimer Disease"

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

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ClinicalTrials.gov Identifier: NCT03503331
Recruitment Status : Recruiting
First Posted : April 19, 2018
Last Update Posted : April 24, 2018
Sponsor:
Information provided by (Responsible Party):
Jonathan E McConathy, University of Alabama at Birmingham

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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Drug: [C-11]PiB-PET/MRI Phase 2

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  (Clinical Trial)
Estimated Enrollment : 160 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Brain amyloid PET levels will be measured with the PET tracer [C-11]PiB in all study participants.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: UAB Alzheimer's Disease Center Core Cohort - Imaging Substudy
Actual Study Start Date : April 20, 2018
Estimated Primary Completion Date : April 1, 2024
Estimated Study Completion Date : April 1, 2024


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.




Primary Outcome Measures :
  1. Measurement of pathological beta-amyloid in the brain [ Time Frame: 5 years ]
    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.



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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:

  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03503331


Contacts
Contact: April Riddle 2059346504 ariddle@uabmc.edu
Contact: Marianne Vetrano 205-934-4080 mvetrano@uabmc.edu

Locations
United States, Alabama
University of Alabama at Birmingham Medical Center Recruiting
Birmingham, Alabama, United States, 35294
Contact: Jonathan McConathy, MD    205-996-7115    jmcconathy@uabmc.edu   
Principal Investigator: Jonathan McConathy, MD, PhD         
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         
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Jonathan McConathy, MD University of Alabama at Birmingham

Responsible Party: Jonathan E McConathy, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03503331     History of Changes
Other Study ID Numbers: IRB-300001005
First Posted: April 19, 2018    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: April 2018

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

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders