NCT00205595

Brief Summary

This is a study using Positron Emission Tomography (PET) to study the normal distribution of the PET ligand (R)-\[11C\]PK11195. This ligand will be used to study inflammation in the brain in several brain disorders like Alzheimer's disease and traumatic brain injury.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2001

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2001

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

July 8, 2008

Status Verified

July 1, 2008

First QC Date

September 12, 2005

Last Update Submit

July 3, 2008

Conditions

Normal Aging

Keywords

microgliaPETPK11195

Outcome Measures

Primary Outcomes (1)

  • specific binding of tracer depending on age

Secondary Outcomes (1)

  • tracer kinetic method

Interventions

Positron Emission TomographyDEVICE

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female subjects
  • Good physical and mental Health which will be evaluated with medical history, a physical examination and screening laboratory tests (see appendix 1).
  • Age between 18 and 40 years (20 subjects) and between 40 and 80 years (20 subjects).
  • Mini Mental State score \>27
  • Body Mass Index (B.M.I.) between 20 -25.
  • Written informed consent of the subject.
  • Hb must be \>8 mmol \\ liter at the time of the screening.

You may not qualify if:

  • Previous neurotrauma with loss of consciousness
  • Any clinical significant abnormality of any clinical laboratory test, including drug screening, or ECG abnormality.
  • History of hypertension
  • Any subject who has received any investigational medication within 30 days prior to the start of this study, or who is scheduled to receive an investigational drug.
  • History of psychiatric or neurological illness
  • History of psychiatric or neurological illness in first-degree relatives
  • History of alcohol and/or drug abuse (DSM-IV criteria)
  • Current use of any medication
  • Blood donation within 3 months before the scan day
  • Claustrophobia
  • Metal objects in or around the body (braces, pacemaker, metal fragments);

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VU University Medical Centre

Amsterdam, 1081 HV, Netherlands

Location

MeSH Terms

Interventions

Positron-Emission Tomography

Intervention Hierarchy (Ancestors)

Tomography, Emission-ComputedImage Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisImage EnhancementPhotographyRadionuclide ImagingTomographyDiagnostic Techniques, Radioisotope

Study Officials

  • Bart van Berckel, MD; PhD

    VUmc Medical Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

February 1, 2001

Study Completion

January 1, 2007

Last Updated

July 8, 2008

Record last verified: 2008-07

Locations

NL(1)