PET Imaging Study Using [11C]PIB in Subjects With AD & Healthy Volunteers

Phase 1

Completed

• Conditions: Alzheimer's Disease
• Interventions: Drug: [11C]PIB

• Registration Number: NCT01826110
• Lead Sponsor: Johns Hopkins University

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.

Study Timeline

• Study First Submitted: 2013-02-22
• Study First Submitted QC: 2013-04-03
• Study First Posted: 2013-04-08
• Study Start: 2013-09
• Primary Completion: 2018-07
• Study Completion: 2018-07
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-01
• Last Update Posted: 2019-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[11C]PIB	[11C]PIB	\[11C\]PIB

Primary Outcome Measures

Name	Time	Method
Distribution Volumes of 11C-PIB	Approximately 2 years

Trial Locations

Locations (1)

Johns Hopkins Medical Institution- Dept of Radiology , Division of Nuclear Medicine; 🇺🇸 Baltimore, Maryland, United States