Alzheimer's Disease Education and Referral Center

PET Imaging with [18F]XTRA

PET Imaging with [18F]XTRA

Overall Status: 
Recruiting
Brief Description: 

This trial will test a brain imaging agent called [18F]XTRA, used with positron emission tomography (PET) scanning, to determine if it works better than existing agents to show α4β2-nicotinic acetylcholine receptors in the extrathalamic regions of the human brain. Imaging these regions may prove to be useful in detecting early changes and following functional deterioration in diseases such as Alzheimer's. Healthy volunteers age 18 to 85 years old and people with Alzheimer's disease or mild cognitive impairment age 60 to 85 years old are invited to participate.

Patient Qualifications: 
Min AgeMax AgeGenderHealthy Volunteers
18 Years
85 Years
Both
Accepts Healthy Volunteers
Inclusion Criteria: 
    • Healthy volunteers, ages 18-85, and people with Alzheimer's disease or mild cognitive impairment, ages 60-85
    • Screening laboratory test results within normal limits for gender and age
    • Electrocardiogram (ECG) conducted within 10 days before the PET study and again within 10 days after the study
    • Participant agrees to return to the study site for follow-up ECG and laboratory testing of blood and urine 
Exclusion Criteria: 
    • History of epilepsy, focal structural central nervous system abnormality, such as stroke, or arteriovenous malformation
    • History of head injury with loss of consciousness for more than 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 would constitute a safety risk to the participant
    • Any radiation exposure in the past calendar year that, in combination with the radiation exposure from this study, would exceed 5 rem
    • Contraindications to MRI scanning if MRI is to be obtained, including pacemakers, metallic implants/prosthesis, or prohibitive claustrophobia
    • Contraindications to PET scanning, including pregnancy (female participants of childbearing potentia must test negative for pregnancy within 10 days before PET scan
Detailed Description: 

The use of PET imaging of α4β2-nicotinic acetylcholine receptors in the extrathalamic regions of the brain may help detect early changes in the brains of people with Alzheimer's disease and follow the disease as it progresses. The extrathalamic regions include the hippocampus, cortex and caudate. Furthermore, PET imaging of these receptors may allow investigation and development of new therapies acting on the acetylcholine system, neurotransmitters that play a role in Alzheimer's.

This study is designed to determine brain uptake of the imaging agent [18F]XTRA. Participants will receive an injection of the agent, followed by a PET scan.

Locations: 
Map Marker CityStateZip CodeStatusPrimary Contact

Geolocation is 39.2962372, -76.5928888

Johns Hopkins University
Baltimore
Maryland
21287
Recruiting
Martin G. Pomper
410-955-2789
mpomper1@jhmi.edu
Lead Sponsor: 
Agency
Johns Hopkins University
Collaborator Sponsor: 
Agency
National Institutes of Health (NIH)
Facility Investigators: 
NameRoleAffiliation
Martin G. Pomper, PhD
Principal Investigator
Johns Hopkins University
Study Contact: 
NamePhoneEmail
Martin G. Pomper, PhD
410-955-2789
Jennifer M. Coughlin, MD
410-746-6072
Locations
 
 
ClinicalTrials.gov ID 
NCT01894646 (follow link to view full record on ct.gov in new window)
Official Title: 
PET Imaging of Extrathalamic α4β2-nicotinic Acetylcholine Receptors in Health and Disease With [18F]XTRA
Study Start Date: 
February 2013
Study End Date: 
February 2016
Enrollment: 
60