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

Primary Purpose

HIV-Dementia, HIV-Associated Cognitive Motor Complex, AIDS Encephalopathy

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

[11C]PBR28

About this trial

This is an interventional treatment trial for HIV-Dementia focused on measuring HIV-Dementia, Brain, PET, PBR28, MCMD, HIV Positive, HIV Dementia, AIDS Related Dementia, Minor Cognitive Motor Disorder, Healthy Volunteer, HV

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

HIV-seropositive based on ELISA and Western blot (except the HIV-seronegative subjects, who will have ELISA screening).
Capable of providing informed consent.
Ambulatory at initial visit.
If cognitively impaired, the degree of impairment will be MCMD, and not frank HIV-associated dementia.

EXCLUSION CRITERIA:

Current psychiatric illness or severe systemic disease based on history and physical exam
Current dependence on alcohol or substances other than nicotine.
Laboratory results from blood or urine tests that show clinically significant abnormalities.
Previous radiation exposure (X-rays, PET scans etc.) that would exceed research limits.
Pregnancy and breast feeding.
A history of brain disease.
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.
More than moderate hypertension.
Positive result on urine screen for illicit drugs.

Sites / Locations

National Institutes of Health Clinical Center, 9000 Rockville Pike

Outcomes

Primary Outcome Measures

Brain uptake of [11C]PBR28 (measured as distribution volume).

Secondary Outcome Measures

Full Information

NCT ID

NCT00459693

First Posted

April 11, 2007

Last Updated

September 3, 2020

Sponsor

National Institute of Mental Health (NIMH)

1. Study Identification

Unique Protocol Identification Number

NCT00459693

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 28, 2014

Overall Recruitment Status

Terminated

Study Start Date

April 9, 2007 (undefined)

Primary Completion Date

April 6, 2014 (Actual)

Study Completion Date

April 6, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Institute of Mental Health (NIMH)

4. Oversight

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

HIV-Dementia, Brain, PET, PBR28, MCMD, HIV Positive, HIV Dementia, AIDS Related Dementia, Minor Cognitive Motor Disorder, Healthy Volunteer, HV

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

[11C]PBR28

Primary Outcome Measure Information:

Title

Brain uptake of [11C]PBR28 (measured as distribution volume).

Time Frame

One brain PET scan in one outpatient visit to NIH per subject.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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. HIV-seropositive based on ELISA and Western blot (except the HIV-seronegative subjects, who will have ELISA screening). Capable of providing informed consent. Ambulatory at initial visit. If cognitively impaired, the degree of impairment will be MCMD, and not frank HIV-associated dementia. EXCLUSION CRITERIA: Current psychiatric illness or severe systemic disease based on history and physical exam Current dependence on alcohol or substances other than nicotine. Laboratory results from blood or urine tests that show clinically significant abnormalities. Previous radiation exposure (X-rays, PET scans etc.) that would exceed research limits. Pregnancy and breast feeding. A history of brain disease. 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. More than moderate hypertension. Positive result on urine screen for illicit drugs.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

William C Kreisl, M.D.

Organizational Affiliation

National Institute of Mental Health (NIMH)

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Institutes of Health Clinical Center, 9000 Rockville Pike

City

Bethesda

State/Province

Maryland

ZIP/Postal Code

20892

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

12394782

Citation

Anderson E, Zink W, Xiong H, Gendelman HE. HIV-1-associated dementia: a metabolic encephalopathy perpetrated by virus-infected and immune-competent mononuclear phagocytes. J Acquir Immune Defic Syndr. 2002 Oct 1;31 Suppl 2:S43-54. doi: 10.1097/00126334-200210012-00004.

Results Reference

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PubMed Identifier

2987488

Citation

Anholt RR, De Souza EB, Oster-Granite ML, Snyder SH. Peripheral-type benzodiazepine receptors: autoradiographic localization in whole-body sections of neonatal rats. J Pharmacol Exp Ther. 1985 May;233(2):517-26.

Results Reference

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PubMed Identifier

12092785

Citation

Amodio P, Wenin H, Del Piccolo F, Mapelli D, Montagnese S, Pellegrini A, Musto C, Gatta A, Umilta C. Variability of trail making test, symbol digit test and line trait test in normal people. A normative study taking into account age-dependent decline and sociobiological variables. Aging Clin Exp Res. 2002 Apr;14(2):117-31. doi: 10.1007/BF03324425.

Results Reference

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

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