NCT00459693

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 9, 2007

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 11, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 12, 2007

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 6, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 6, 2014

Completed
Last Updated

September 10, 2020

Status Verified

August 28, 2014

Enrollment Period

7 years

First QC Date

April 11, 2007

Last Update Submit

September 3, 2020

Conditions

HIV-DementiaHIV-Associated Cognitive Motor ComplexAIDS EncephalopathyAIDS Dementia ComplexAIDS-Related Dementia ComplexHIV InfectionsHealthy

Keywords

HIV-DementiaBrainPETPBR28MCMDHIV PositiveHIV DementiaAIDS Related DementiaMinor Cognitive Motor DisorderHealthy VolunteerHV

Outcome Measures

Primary Outcomes (1)

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

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

Interventions

[11C]PBR28DRUG

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • 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.

    PMID: 12394782BACKGROUND

  • 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.

    PMID: 2987488BACKGROUND

  • 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.

    PMID: 12092785BACKGROUND

MeSH Terms

Conditions

AIDS Dementia ComplexHIV InfectionsHIV Seropositivity

Interventions

(methyl-(11)C)N-acetyl-N-(2-methoxybenzyl)-2-phenoxy-5-pyridinamine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • William C Kreisl, M.D.

    National Institute of Mental Health (NIMH)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2007

First Posted

April 12, 2007

Study Start

April 9, 2007

Primary Completion

April 6, 2014

Study Completion

April 6, 2014

Last Updated

September 10, 2020

Record last verified: 2014-08-28

Locations

US(1)