NIH Clinical Research Studies

Protocol Number: 08-M-0066

Active Accrual, Protocols Recruiting New Patients

Title:
PET Evaluation of Brain Peripheral Benzodiazepine Receptors Using [11C]PBR28 in Dementia
Number:
08-M-0066
Summary:
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, 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.

Sponsoring Institute:
National Institute of Mental Health (NIMH)
Recruitment Detail
Type: Participants currently recruited/enrolled
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): Children

Eligibility Criteria:
INCLUSION CRITERIA:

-Frontotemporal dementia (FTD) patients with or without motor involvement. Patients with either the frontal variant (also known as the behavioral variant) or the language variant of FTD may be included. FTD patients must either meet capacity criteria to consent to research, or be able to assign a surrogate decision-maker who is able to consent to research on the subject's behalf.

-Healthy volunteers.

EXCLUSION CRITERIA:

-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.

-Presence of ferromagnetic metal in the body or heart pacemaker.

Special Instructions:
Currently Not Provided
Keywords:
Inflammation
Frontotemporal Dementia
Dementia
PBR28
PET Imaging
Recruitment Keyword(s):
None
Condition(s):
Frontotemporal Lobar Degeneration
Dementia
Investigational Drug(s):
[11C]PBR28
Investigational Device(s):
None
Intervention(s):
None
Supporting Site:
National Institute of Mental Health

Contact(s):
Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):
Aisen PS, Davis KL. Inflammatory mechanisms in Alzheimer's disease: implications for therapy. Am J Psychiatry. 1994 Aug;151(8):1105-13. Review.

Anholt RR, De Souza EB, Oster-Granite ML, Snyder SH. Peripheral-type benzodiazepine receptors: autoradiographic localization in whole-body sections of neonatal rats. J Pharmacol Exp Ther. 1985 May;233(2):517-26.

Baker M, Mackenzie IR, Pickering-Brown SM, Gass J, Rademakers R, Lindholm C, Snowden J, Adamson J, Sadovnick AD, Rollinson S, Cannon A, Dwosh E, Neary D,Melquist S, Richardson A, Dickson D, Berger Z, Eriksen J, Robinson T, Zehr C, Dickey CA, Crook R, McGowan E, Mann D, Boeve B, Feldman H, Hutton M. Mutations in progranulin cause tau-negative frontotemporal dementia linked to chromosome 17. Nature. 2006 Aug 24;442(7105):916-9. Epub 2006 Jul 16.

Active Accrual, Protocols Recruiting New Patients

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