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

Not Applicable

Terminated

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

• Registration Number: NCT00459693
• Lead Sponsor: National Institute of Mental Health (NIMH)

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.

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 Timeline

• Study Start: 2007-04-09
• Study First Submitted: 2007-04-11
• Study First Submitted QC: 2007-04-11
• Study First Posted: 2007-04-12
• Primary Completion: 2014-04-06
• Study Completion: 2014-04-06
• Status Verified: 2014-08-28
• Disposition First Submitted: 2020-09-03
• Disposition First Submitted QC: 2020-09-03
• Last Update Submitted: 2020-09-03
• Disposition First Posted: 2020-09-10
• Last Update Posted: 2020-09-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike; 🇺🇸 Bethesda, Maryland, United States