Healthy Clinical Trial
Official title:
PET Evaluation of Brain Peripheral Benzodiazepine Receptors Using (11C)PBR28 in HIV-Seropositive Patients With (MCMD)
Verified date | August 28, 2014 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this protocol is to measure a receptor in the brain using positron emission tomography (PET) that is involved in inflammation.
Status | Terminated |
Enrollment | 40 |
Est. completion date | April 6, 2014 |
Est. primary completion date | April 6, 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility |
- INCLUSION CRITERIA: Inclusion criteria (healthy control subjects) aged 18 50 years with history/physical exam, ECG, and laboratory tests, plus inclusion criteria listed will be included in the protocol. 1. HIV-seropositive based on ELISA and Western blot (except the HIV-seronegative subjects, who will have ELISA screening). 2. Capable of providing informed consent. 3. Ambulatory at initial visit. 4. If cognitively impaired, the degree of impairment will be MCMD, and not frank HIV-associated dementia. EXCLUSION CRITERIA: 1. Current psychiatric illness or severe systemic disease based on history and physical exam 2. Current dependence on alcohol or substances other than nicotine. 3. Laboratory results from blood or urine tests that show clinically significant abnormalities. 4. Previous radiation exposure (X-rays, PET scans etc.) that would exceed research limits. 5. Pregnancy and breast feeding. 6. A history of brain disease. 7. Cannot lie on your back for long periods since the pictures will be taken for about 2.5 hours during which time you will have to lie still on the scanner bed. 8. More than moderate hypertension. 9. Positive result on urine screen for illicit drugs. |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute of Mental Health (NIMH) |
United States,
Amodio P, Wenin H, Del Piccolo F, Mapelli D, Montagnese S, Pellegrini A, Musto C, Gatta A, Umiltà C. Variability of trail making test, symbol digit test and line trait test in normal people. A normative study taking into account age-dependent decline and sociobiological variables. Aging Clin Exp Res. 2002 Apr;14(2):117-31. — View Citation
Anderson E, Zink W, Xiong H, Gendelman HE. HIV-1-associated dementia: a metabolic encephalopathy perpetrated by virus-infected and immune-competent mononuclear phagocytes. J Acquir Immune Defic Syndr. 2002 Oct 1;31 Suppl 2:S43-54. Review. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Brain uptake of [11C]PBR28 (measured as distribution volume). | One brain PET scan in one outpatient visit to NIH per subject. |
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