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Trial record 5 of 14 for:    glutamate antagonist | Parkinson Disease

Parkinson's Disease Evaluated by PET and the Effect of Memantine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00375778
Recruitment Status : Completed
First Posted : September 13, 2006
Last Update Posted : September 13, 2006
Sponsor:
Collaborator:
Lundbeck Foundation
Information provided by:
University of Aarhus

Tracking Information
First Submitted Date  ICMJE September 12, 2006
First Posted Date  ICMJE September 13, 2006
Last Update Posted Date September 13, 2006
Study Start Date  ICMJE April 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Parkinson's Disease Evaluated by PET and the Effect of Memantine
Official Title  ICMJE Parkinson's Disease Evaluated by Positron Emission Tomography and the Effect of the NMDA Receptor Antagonist Memantine
Brief Summary

Purpose of study: To investigate whether the NMDA antagonist Memantine has a substantial effect of brain metabolism in patients with Parkinson's disease (PD), using Positron Emission Tomography (PET).

Background: Disturbances in brain metabolism is thought to contribute to degeneration of neurons in brain of PD patients. Production of toxic oxygen radicals and presence of too much excitatory neurotransmitter (glutamate) due to over activity is involved. These factors can theoretically be alleviated by memantine.

Hypothesis: Memantine decreases metabolism in areas in PD brain known to be over-active. Decreases in cerebral blood flow and oxygen metabolism in these areas will be the consequence and this can be detected by PET.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Parkinson's Disease
Intervention  ICMJE Drug: memantine (drug)
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September¬†12,¬†2006)
12
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE September 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Parkinson's Disease (British Brain Bank Criteria)
  • Age 50-70y

Exclusion Criteria:

  • Tobacco use
  • Any serious medical conditions (Heart disease, kidney disease, liver disease, endocrinological disorders etc)
  • Metal implants contraindicating MR scan
  • Drug use affecting the central nervous system
  • Psychiatric disorders
  • Head trauma or any disorders of the head, skull or brain
  • Drug addiction or use of any kind of illegal substance affecting the central nervous system
  • Pregnancy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00375778
Other Study ID Numbers  ICMJE 2004-004139-74
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University of Aarhus
Collaborators  ICMJE Lundbeck Foundation
Investigators  ICMJE
Principal Investigator: Karen Ostergaard, MD, Ph.D Aarhus University Hospital
PRS Account University of Aarhus
Verification Date September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP