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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00375778
Other study ID # 2004-004139-74
Secondary ID
Status Completed
Phase N/A
First received September 12, 2006
Last updated September 12, 2006
Start date April 2005
Est. completion date September 2006

Study information

Verified date September 2006
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Medicines Agency
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date September 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 50 Years to 70 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
memantine (drug)


Locations

Country Name City State
Denmark PET center, Aarhus University Hospital Aarhus

Sponsors (2)

Lead Sponsor Collaborator
University of Aarhus Lundbeck Foundation

Country where clinical trial is conducted

Denmark, 

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