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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00459693
Recruitment Status : Terminated
First Posted : April 12, 2007
Last Update Posted : October 6, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this protocol is to measure a receptor in the brain using positron emission tomography (PET) that is involved in inflammation.

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

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.


Study Design

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
Primary Completion Date : April 6, 2014
Study Completion Date : April 6, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions


Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • 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.
Contacts and Locations

Information from the National Library of Medicine

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


Locations
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)
Investigators
Principal Investigator: William C Kreisl, M.D. National Institute of Mental Health (NIMH)
More Information

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: October 6, 2017
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