PET Evaluation of Brain Peripheral Benzodiazepine Receptors Using [11C]PBR28 in Frontotemporal Dementia

Completed

Conditions studied: Frontotemporal Lobar Degeneration, Dementia

In brief

This study will use positron emission tomography (PET) imaging to measure a receptor in the brain that is involved in inflammation. Certain neurological disorders, possibly including frontotemporal dementia (FTD), are associated with increased inflammation in the brain. This study may help elucidate the relationship between FTD and inflammation. Patients with FTD and healthy volunteers who are 35 years of age or older may be eligible for this study. Candidates are screened with a medical history, physical examination, electrocardiogram, and blood and urine tests. Participants undergo the following procedures: * Whole body PET scan: PET uses small amounts of a radioactive chemical called a tracer that labels active areas of the brain so the activity can be seen with a special camera. The tracer used in this study is \[11C\]PBR28. Before starting the scan, a catheter (plastic tube) is placed in a vein in the arm to inject the tracer. Pictures are taken for 1 hour. This short scan is done to determine if \[11C\]PBR28 binds to the subject s receptors, since a number of people do not have binding. Subjects who have binding continue with brain PET and MRI scans, described below. * Brain PET imaging: Before starting the scan, a catheter is placed in a vein in the arm to inject the tracer,\<TAB\> and another catheter is placed in an artery in the wrist to obtain blood samples during the scan. The subject lies on the scanner bed. A special mask is fitted to the head and attached to the bed to help keep the person s head still during the scan so the images will be clear. An 8-minute transmission scan is done just before the tracer is injected to provide measures of the brain that are helpful in calculating information from subsequent scans. After the tracer is injected, pictures are taken for about 2.5 hours, while the subject lies still on the scanner bed. * Blood and urine tests are done the day of and the day following each PET scan. * Magnetic resonance imaging (MRI): An MRI scan is done within 1 year (before or after) of the PET scan. This procedure uses a magnetic field and radio waves to produce images of the brain. The subject lies on a table that is moved into the scanner (a tube-like device), wearing earplugs to muffle the noise of the machine during the scanning process. The test takes about 1 hour....

Key facts

Study ID: NCT00613119
Run by: National Institute of Mental Health (NIMH)
People needed: 108
Starts: 2008-01-31
Expected to finish: 2017-07-13
Last updated by the study team: 2019-12-16

Who can join

Age: 35 and older. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

Current psychiatric disease, substance abuse or severe systemic disease based on history and physical exam.
Laboratory tests with clinically significant abnormalities.
Prior participation in other research protocols or clinical care in the last year such that radiation exposure, including that from this protocol, would exceed the guidelines set by the Radiation Safety Committee (RSC).
Pregnancy or breast feeding.
Positive result on urine screen for illicit drugs.
Subjects who cannot lie on their back for extended periods of time.
History of neurological disease other than FTD or AD or TLE.
TLE patients:
with a known treatable seizure etiology such as neoplastic or infectious disease
with an MRI finding consistent with a brain tumor, trauma or arterial-venous malformations
with seizure activity within 24 hours prior to the study.
not capable of giving an informed consent.
Presence of ferromagnetic metal in the body or heart pacemaker.

Where it is running

National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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