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

Primary Purpose

Parkinson's Disease

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

memantine (drug)

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's Disease, Positron Emission Tomography, Memantine, NMDA antagonists, Cerebral Blood Flow, Cerebral Metabolic Rate of Oxygen

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

PET center, Aarhus University Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00375778

First Posted

September 12, 2006

Last Updated

September 12, 2006

Sponsor

University of Aarhus

Collaborators

Lundbeck Foundation

1. Study Identification

Unique Protocol Identification Number

NCT00375778

Brief Title

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

Official Title

Parkinson's Disease Evaluated by Positron Emission Tomography and the Effect of the NMDA Receptor Antagonist Memantine

Study Type

Interventional

2. Study Status

Record Verification Date

September 2006

Overall Recruitment Status

Completed

Study Start Date

April 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

September 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University of Aarhus

Collaborators

Lundbeck Foundation

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson's Disease

Keywords

Parkinson's Disease, Positron Emission Tomography, Memantine, NMDA antagonists, Cerebral Blood Flow, Cerebral Metabolic Rate of Oxygen

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

12 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

memantine (drug)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Karen Ostergaard, MD, Ph.D

Organizational Affiliation

Aarhus University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

PET center, Aarhus University Hospital

City

Aarhus

ZIP/Postal Code

8000

Country

Denmark

12. IPD Sharing Statement

Learn more about this trial

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

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