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

• Status: Completed
• Trial end date: 2018-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Dean F. Wong, MD, PhD; Johns Hopkins University
• Collaborator: National Institute on Aging (NIA)

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)