Clinical trial NCT01826110: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2013-04-08
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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)

Primary outcomes:
measure: Distribution Volumes of 11C-PIB
timeFrame: Approximately 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Medical Institution- Dept of Radiology , Division of Nuclear Medicine
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Dean F Wong, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: