Status:

UNKNOWN

Normal Binding of R-[11C]PK11195 in Human Subjects

Lead Sponsor:

Amsterdam UMC, location VUmc

Conditions:

Normal Aging

Eligibility:

All Genders

18-80 years

Phase:

PHASE1

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 b...

Detailed Description

At the University Hospital Vrije Universiteit the PET ligand PK11195 labeled with carbon-11, (R)-\[11C\]PK11195, will be used to study microglia activation in-vivo in patients with traumatic brain dam...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

  • 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);

Key Trial Info

Start Date :

February 1 2001

Trial Type :

INTERVENTIONAL

End Date :

January 1 2007

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT00205595

Start Date

February 1 2001

End Date

January 1 2007

Last Update

July 8 2008

Active Locations (1)

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1

VU University Medical Centre

Amsterdam, Netherlands, 1081 HV