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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
ClinicalTrials.gov Identifier:
NCT00459693
First received: April 11, 2007
Last updated: May 7, 2013
Last verified: April 2013
History of Changes
  Purpose

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-Dementia
HIV-Associated Cognitive Motor Complex
AIDS Encephalopathy
AIDS Dementia Complex
AIDS-Related Dementia Complex
HIV Infections
Healthy
 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:

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

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. ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: April 2007
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: [11C]PBR28
    N/A
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00459693

Locations
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
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

Additional Information:
NIH Clinical Center Detailed Web Page  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
ClinicalTrials.gov Identifier: NCT00459693     History of Changes
Other Study ID Numbers: 070129, 07-M-0129
Study First Received: April 11, 2007
Last Updated: May 7, 2013
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
HIV-Dementia
HIV Positive
HIV Dementia
Brain
PET
PBR28
 MCMD
AIDS Related Dementia
Minor Cognitive Motor Disorder
Healthy Volunteer
HV

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
HIV Seropositivity
AIDS Dementia Complex
Dementia
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
 Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 18, 2013