PET Evaluation of Brain Peripheral Benzodiazepine Receptors Using [11C]PBR28 in HIV-Seropositive Patients With (MCMD)
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ClinicalTrials.gov Identifier: NCT00459693 |
Recruitment Status
:
Terminated
First Posted
: April 12, 2007
Last Update Posted
: April 4, 2018
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV-Dementia HIV-Associated Cognitive Motor Complex AIDS Encephalopathy AIDS Dementia Complex AIDS-Related Dementia Complex HIV Infections Healthy | Drug: [11C]PBR28 | Not Applicable |
The peripheral benzodiazepine receptor (PBR) is distinct from central benzodiazepine receptors associated with GABAa receptors. Although PBR was initially identified in peripheral organs such as kidneys, endocrine glands and lungs, later studies identified PBR in the central nervous system. In normal conditions, PBR is expressed in low levels in some neurons and glial cells. PBR can be a clinically useful marker to detect neuroinflammation, because activated microglial cells in inflammatory areas express much greater levels of PBR than in microglial cells in resting conditions.
PBR has been imaged with positron emission tomography (PET) using [11C]1-(2-chlorophenyl-N-methylpropyl)-3-isoquinoline carboxamide (PK11195). However, this classical ligand provides low levels of specific signal. Recently we developed a new ligand, N-acetyl-N-(2-methoxybenzyl)-2-phenoxy-5-pyridinamine [11C]PBR28, which showed much greater specific signal than [11C]PK11195 in non-human primates. ln the present protocol we plan to perform a kinetic brain imaging study with [11C]PBR28 in HlV-seronegative controls, HIV-seropositive, non-impaired patients, and HlV-seropositive patients with minor cognitive motor disorder(MCMD). Each subject will recieve a brain-dedicated PET scan with 20 mCi[(11)C]PBR28.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 40 participants |
Primary Purpose: | Treatment |
Official Title: | PET Evaluation of Brain Peripheral Benzodiazepine Receptors Using (11C)PBR28 in HIV-Seropositive Patients With (MCMD) |
Study Start Date : | April 9, 2007 |
Actual Primary Completion Date : | April 6, 2014 |
Actual Study Completion Date : | April 6, 2014 |

- Brain uptake of [11C]PBR28 (measured as distribution volume). [ Time Frame: One brain PET scan in one outpatient visit to NIH per subject. ]

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
- 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.
- HIV-seropositive based on ELISA and Western blot (except the HIV-seronegative subjects, who will have ELISA screening).
- Capable of providing informed consent.
- Ambulatory at initial visit.
- If cognitively impaired, the degree of impairment will be MCMD, and not frank HIV-associated dementia.
EXCLUSION CRITERIA:
- Current psychiatric illness or severe systemic disease based on history and physical exam
- Current dependence on alcohol or substances other than nicotine.
- Laboratory results from blood or urine tests that show clinically significant abnormalities.
- Previous radiation exposure (X-rays, PET scans etc.) that would exceed research limits.
- Pregnancy and breast feeding.
- A history of brain disease.
- 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.
- More than moderate hypertension.
- Positive result on urine screen for illicit drugs.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00459693
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | |
Bethesda, Maryland, United States, 20892 |
Principal Investigator: | William C Kreisl, M.D. | National Institute of Mental Health (NIMH) |
Publications:
Responsible Party: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00459693 History of Changes |
Other Study ID Numbers: |
070129 07-M-0129 |
First Posted: | April 12, 2007 Key Record Dates |
Last Update Posted: | April 4, 2018 |
Last Verified: | August 28, 2014 |
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) ):
HIV-Dementia HIV Positive HIV Dementia Brain PET PBR28 |
MCMD AIDS Related Dementia Minor Cognitive Motor Disorder Healthy Volunteer HV |
Additional relevant MeSH terms:
HIV Infections HIV Seropositivity Dementia Alzheimer Disease Brain Diseases AIDS Dementia Complex Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Central Nervous System Diseases Nervous System Diseases Neurocognitive Disorders Mental Disorders Tauopathies Neurodegenerative Diseases |