Back to resultsPET Imaging Study Using [11C]PIB in Subjects With AD & Healthy Volunteers
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
[11C]PIB
Sponsored by
About this trial
This is an interventional basic science trial for Alzheimer's Disease
Eligibility Criteria
Inclusion Criteria:
- Male or female subjects at least 18 years of age
- Subjects who in the opinion of the investigator based on medical history and physical exam can tolerate the PET scan procedures
Exclusion Criteria:
- Have clinically significant hepatic, renal, pulmonary, metabolic, or endocrine disturbances
- Have current clinically significant cardiovascular disease.
- Have a history of drug or alcohol abuse within the last year, or prior prolonged history of abuse
- Have a clinically significant infectious disease, including Acquired Immune Deficiency Syndrome (AIDS) or Human Immunodeficiency Virus (HIV) infection or previous positive test for hepatitis
- Women of childbearing potential must not be pregnant (negative urine beta-hCG at the time of screening and negative urine beta-hCG on the day of imaging) or lactating at screening or at day of imaging
- Have a history of relevant severe drug allergy or hypersensitivity (Relevant severe drug allergies should be determined by the PI, and any questions about a subject's eligibility can be directed to Avid. If a subject has a history of severe drug allergies, it may be dangerous for them to participate in a study with a novel compound
- Have received an investigational medication within the last 30 days. Current clinically significant or unstable medical comorbidities, as indicated by history or physical exam
- Have received a radiopharmaceutical for imaging or therapy within the past 7 days prior to the imaging session for this study
- Body weight > 300 pounds
- History of significant radiation exposure
- Participants with pacemakers, implanted electronic hearing devices, aneurysm clips, shrapnel, unallowed prosthetic or other metallic device in their bodies
- Pre-existing CNS disease (other than dementia), endocrine, or severe cardiovascular disease (MI, CABG, angioplasty)
Sites / Locations
- Johns Hopkins Medical Institution- Dept of Radiology , Division of Nuclear Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
[11C]PIB
Arm Description
[11C]PIB
Outcomes
Primary Outcome Measures
Distribution Volumes of 11C-PIB
Secondary Outcome Measures
Full Information
NCT ID
NCT01826110
First Posted
February 22, 2013
Last Updated
March 1, 2019
Sponsor
Johns Hopkins University
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT01826110
Brief Title
PET Imaging Study Using [11C]PIB in Subjects With AD & Healthy Volunteers
Official Title
"[11C] PIB Comparison Study to [18F] AV-45 in Subjects With Alzheimer's Disease (AD) and Age Matched Healthy Controls"
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
July 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute on Aging (NIA)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to investigate the radiotracer [11C] PIB in participants with probably Alzheimer's Disease (AD) and healthy age-matched controls.
Detailed Description
The objectives of the study are:
To perform PET scans with [11C]PIB to use for direct (i.e., same-subjects) comparison of [11C]PIB and [18F]AV-45
To establish the most effective and reliable PET imaging method to detect amyloid deposition in AD, in order to understand disease progression and subsequently evaluate treatment effects.
To ascertain a PET imaging method that will minimize discomfort for subjects, thus increasing the potential for clinical follow-up scans, by reducing the patient burden and potential cost of future PET examinations.
A separate protocol/study will be conducted using [18F] AV-45. Participants who enroll in this protocol using [11C] PIB will be consented to participate in the [18F] AV-45 (IRB # NA_00033155) protocol/study as it is a mandatory requirement that participants participate in both protocols.Up to 20 participants with mild to moderate Alzheimer's Disease and 10 healthy volunteers will participate in this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
[11C]PIB
Arm Type
Experimental
Arm Description
[11C]PIB
Intervention Type
Drug
Intervention Name(s)
[11C]PIB
Intervention Description
Approximately 15 mCI [11C]PIB IV x1
Primary Outcome Measure Information:
Title
Distribution Volumes of 11C-PIB
Time Frame
Approximately 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male or female subjects at least 18 years of age
Subjects who in the opinion of the investigator based on medical history and physical exam can tolerate the PET scan procedures
Exclusion Criteria:
Have clinically significant hepatic, renal, pulmonary, metabolic, or endocrine disturbances
Have current clinically significant cardiovascular disease.
Have a history of drug or alcohol abuse within the last year, or prior prolonged history of abuse
Have a clinically significant infectious disease, including Acquired Immune Deficiency Syndrome (AIDS) or Human Immunodeficiency Virus (HIV) infection or previous positive test for hepatitis
Women of childbearing potential must not be pregnant (negative urine beta-hCG at the time of screening and negative urine beta-hCG on the day of imaging) or lactating at screening or at day of imaging
Have a history of relevant severe drug allergy or hypersensitivity (Relevant severe drug allergies should be determined by the PI, and any questions about a subject's eligibility can be directed to Avid. If a subject has a history of severe drug allergies, it may be dangerous for them to participate in a study with a novel compound
Have received an investigational medication within the last 30 days. Current clinically significant or unstable medical comorbidities, as indicated by history or physical exam
Have received a radiopharmaceutical for imaging or therapy within the past 7 days prior to the imaging session for this study
Body weight > 300 pounds
History of significant radiation exposure
Participants with pacemakers, implanted electronic hearing devices, aneurysm clips, shrapnel, unallowed prosthetic or other metallic device in their bodies
Pre-existing CNS disease (other than dementia), endocrine, or severe cardiovascular disease (MI, CABG, angioplasty)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dean F Wong, MD, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Medical Institution- Dept of Radiology , Division of Nuclear Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
12. IPD Sharing Statement
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PET Imaging Study Using [11C]PIB in Subjects With AD & Healthy Volunteers
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