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

NCT01826110 | Completed Phase 1

• 2 other identifiers: NA_000331541R21AG056142-01
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• Distribution Volumes of 11C-PIB

  Approximately 2 years

Study Arms (1)

[11C]PIB

EXPERIMENTAL

\[11C\]PIB

Drug: [11C]PIB

Interventions

[11C]PIB DRUG

Approximately 15 mCI \[11C\]PIB IV x1

[11C]PIB

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Johns Hopkins Medical Institution- Dept of Radiology , Division of Nuclear Medicine

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

2-(4'-(methylamino)phenyl)-6-hydroxybenzothiazole

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Dean F Wong, MD, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2013
• First Posted: April 8, 2013
• Study Start: September 1, 2013
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: March 5, 2019

Record last verified: 2019-03

Locations

US (1)