Status:
COMPLETED
PET Imaging Study Using [11C]PIB in Subjects With AD & Healthy Volunteers
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
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: 1. To perform PET scans with \[11C\]PIB to use for direct (i.e., same-subjects) comparison of \[11C\]PIB and \[18F\]AV-45 2. To establish the most effective and relia...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2018
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01826110
Start Date
September 1 2013
End Date
July 1 2018
Last Update
March 5 2019
Active Locations (1)
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1
Johns Hopkins Medical Institution- Dept of Radiology , Division of Nuclear Medicine
Baltimore, Maryland, United States, 21287