Status:
TERMINATED
PET Imaging of Extrathalamic α4β2-nicotinic Acetylcholine Receptors in Health and Disease With [18F]XTRA
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Measure of Uptake of XTRA in the Brain
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
Brief Summary
Currently, only three radiotracers, (2-\[18F\]FA, 6-\[18F\]FA and \[18F\]AZAN), are available for studying α4β2-nicotinic acetylcholine receptors (α4β2-nAChR) in human brain using PET imaging. A cruci...
Eligibility Criteria
Inclusion
- The population consists of healthy adults 18-85 years of age. There is no race or sex bias in our recruitment.
- a. Inclusion criteria.
- healthy volunteer, 18-80 years of age, and in portion 2, patient with Alzheimer's disease or patient with mild cognitive impairment (age 60-80 years)
- screening laboratory tests will be obtained for subjects within a 10-day period prior to the PET study and the results must be within normal limits for gender and age. These tests will be repeated with a 10-day window following the PET study.
- ECG conducted within a 10-day period prior to the PET study. The ECG will be repeated within 10 days following the study.
- No contraindications to MRI scanning if MRI is to be obtained in the section for which the subject participates. These contraindications include pacemakers, metallic implants/prosthesis or prohibitive claustrophobia, etc.
- No contraindications to PET scanning to include pregnancy, etc. For females of childbearing potential, negative serum pregnancy test obtained within a 10-day period prior to PET study
- Subject agrees to return to the Hospital for f/u ECG and laboratory testing of blood and urine
Exclusion
- Participants with history of epilepsy, focal structural CNS abnormality such as stroke, or arteriovenous malformation
- History of head injury with loss of consciousness \> 1 hour,
- Active substance abuse (drugs or alcohol) or active nicotine use
- ECG demonstrating the participant is not in a sinus rhythm or is having acute ischemia
- Any medical condition that in the opinion of the study investigators would constitute a safety risk to the subject.
- Any radiation exposure in the past calendar year that in combination with the radiation exposure from this study would exceed 5 rem
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2021
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT01894646
Start Date
February 1 2013
End Date
June 1 2021
Last Update
February 18 2022
Active Locations (1)
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1
Johns Hopkins University
Baltimore, Maryland, United States, 21287