Alzheimer's Disease
Conditions
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 reliable PET imaging method to detect amyloid deposition in AD, in order to understand disease progression and subsequently evaluate treatment effects. 3. 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.
Interventions
DRUG[11C]PIB
Approximately 15 mCI \[11C\]PIB IV x1
Sponsors
National Institute on Aging (NIA)
Johns Hopkins University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Distribution Volumes of 11C-PIB | Approximately 2 years |
Countries
United States
Outcome results
None listed