HIV-DementiaNCT00459693
PET Evaluation of Brain Peripheral Benzodiazepine Receptors Using [11C]PBR28 in HIV-Seropositive Patients With (MCMD)
A study testing [11C]PBR28 in people with HIV-Dementia and HIV-Associated Cognitive Motor Complex, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial summary
The purpose of this protocol is to measure a receptor in the brain using positron emission tomography (PET) that is involved in inflammation. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV-Dementia, HIV-Associated Cognitive Motor Complex, AIDS Encephalopathy
- What is being tested?
- [11C]PBR28
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2007to 6 Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: PET Evaluation of Brain Peripheral Benzodiazepine Receptors Using (11C)PBR28 in HIV-Seropositive Patients With (MCMD)
The purpose of this protocol is to measure a receptor in the brain using positron emission tomography (PET) that is involved in inflammation.
Read the 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.
- Conditions
- HIV-Dementia, HIV-Associated Cognitive Motor Complex, AIDS Encephalopathy, AIDS Dementia Complex, AIDS-Related Dementia Complex, HIV Infections
- Being tested
- [11C]PBR28
- Keywords
- HIV-Dementia, Brain, PET, PBR28, MCMD, HIV Positive, HIV Dementia, AIDS Related Dementia, Minor Cognitive Motor Disorder, Healthy Volunteer, HV
- Medical subject headings
- AIDS Dementia Complex, HIV Infections, HIV Seropositivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[11C]PBR28Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain uptake of [11C]PBR28 (measured as distribution volume).
Measured: One brain PET scan in one outpatient visit to NIH per subject.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2007 (estimated)
- Study start9 Apr 2007
- Primary completion6 Apr 2014
- Study completion6 Apr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV-DementiaStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- William C Kreisl, M.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00459693
- Sponsor's protocol ID
- 070129
- Other IDs
- 07-M-0129
- Status last verified
- 28 Aug 2014
- First submitted
- 11 Apr 2007
- Last updated
- 10 Sep 2020
- Results posted
- No
Publications
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.
PubMed 12394782Anholt 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.
PubMed 2987488Amodio 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.
PubMed 12092785
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET Evaluation of Brain Peripheral Benzodiazepine Receptors Using (11C)PBR28 in HIV-Seropositive Patients With (MCMD)
- ClinicalTrials.gov ID
- NCT00459693
- Acronym / sponsor ID
- 070129
- Conditions
- HIV-Dementia, HIV-Associated Cognitive Motor Complex, AIDS Encephalopathy, AIDS Dementia Complex, AIDS-Related Dementia Complex, HIV Infections
- Keywords
- HIV-Dementia, Brain, PET, PBR28, MCMD, HIV Positive, HIV Dementia, AIDS Related Dementia
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 9 Apr 2007
- Primary completion
- 6 Apr 2014 (actual)
- Study completion
- 6 Apr 2014 (actual)
- First posted
- 12 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [11C]PBR28 | Drug | – |
Primary outcome
Brain uptake of [11C]PBR28 (measured as distribution volume).
Time frame: One brain PET scan in one outpatient visit to NIH per subject.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2020.
- Background: PubMed 12394782Anderson 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.
- Background: PubMed 2987488Anholt 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.
- Background: PubMed 12092785Amodio 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William C Kreisl, M.D. principal investigator
National Institute of Mental Health (NIMH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing [11C]PBR28 in people with HIV-Dementia and HIV-Associated Cognitive Motor Complex, run by National Institute of Mental Health (NIMH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain uptake of [11C]PBR28 (measured as distribution volume). (time frame: One brain PET scan in one outpatient visit to NIH per subject.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00459693, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2020.