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| Sponsor: | National Institute of Mental Health (NIMH) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00459693 |
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) |
| Estimated Enrollment: | 60 |
| Study Start Date: | April 2007 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
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 |
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.
EXCLUSION CRITERIA:
Contacts and Locations| Contact: Justin McArthur, M.D. | (410) 955-3730 | |
| Contact: William C Kreisl, M.D. | (301) 451-8894 | kreislw@mail.nih.gov |
| United States, Maryland | |
| Johns Hopkins University | Recruiting |
| Baltimore, Maryland, United States, 21205 | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 prpl@mail.cc.nih.gov | |
| Principal Investigator: | William C Kreisl, M.D. | National Institute of Mental Health (NIMH) |
More Information
| Responsible Party: | Robert B. Innis, M.D./National Institute of Mental Health, National Institutes of Health |
| ClinicalTrials.gov Identifier: | NCT00459693 History of Changes |
| Other Study ID Numbers: | 070129, 07-M-0129 |
| Study First Received: | April 11, 2007 |
| Last Updated: | March 20, 2012 |
| Health Authority: | United States: Federal Government |
|
HIV-Dementia Brain PET PBR28 MCMD HIV Positive |
HIV Dementia AIDS Related Dementia Minor Cognitive Motor Disorder Healthy Volunteer HV |
|
HIV Infections Acquired Immunodeficiency Syndrome AIDS Dementia Complex Dementia HIV Seropositivity Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral |
Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |