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PET Evaluation of Brain Peripheral Benzodiazepine Receptors Using [11C]PBR28 in HIV-Seropositive Patients With (MCMD)

This study has been terminated.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) ) Identifier:
First received: April 11, 2007
Last updated: April 19, 2017
Last verified: August 28, 2014
The purpose of this protocol is to measure a receptor in the brain using positron emission tomography (PET) that is involved in inflammation.

Condition Intervention
HIV-Associated Cognitive Motor Complex
AIDS Encephalopathy
AIDS Dementia Complex
AIDS-Related Dementia Complex
HIV Infections
Drug: [11C]PBR28

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: PET Evaluation of Brain Peripheral Benzodiazepine Receptors Using (11C)PBR28 in HIV-Seropositive Patients With (MCMD)

Resource links provided by NLM:

Further study details as provided by National Institutes of Health Clinical Center (CC):

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

Enrollment: 40
Study Start Date: April 9, 2007
Study Completion Date: April 6, 2014
Primary Completion Date: April 6, 2014 (Final data collection date for primary outcome measure)
Detailed Description:

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.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.


  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.
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Please refer to this study by its identifier: NCT00459693

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
Principal Investigator: William C Kreisl, M.D. National Institute of Mental Health (NIMH)
  More Information

Responsible Party: National Institute of Mental Health (NIMH) Identifier: NCT00459693     History of Changes
Other Study ID Numbers: 070129
Study First Received: April 11, 2007
Last Updated: April 19, 2017

Keywords provided by National Institutes of Health Clinical Center (CC):
HIV Positive
HIV Dementia
AIDS Related Dementia
Minor Cognitive Motor Disorder
Healthy Volunteer

Additional relevant MeSH terms:
HIV Infections
Alzheimer Disease
Brain Diseases
HIV Seropositivity
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
Neurodegenerative Diseases processed this record on May 24, 2017