NCT00375778

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2005

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2005

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 13, 2006

Completed
Last Updated

September 13, 2006

Status Verified

September 1, 2006

First QC Date

September 12, 2006

Last Update Submit

September 12, 2006

Conditions

Parkinson's Disease

Keywords

Parkinson's DiseasePositron Emission TomographyMemantineNMDA antagonistsCerebral Blood FlowCerebral Metabolic Rate of Oxygen

Interventions

memantine (drug)DRUG

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PET center, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

MemantinePharmaceutical Preparations

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

AmantadineAdamantaneBridged-Ring CompoundsHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Karen Ostergaard, MD, Ph.D

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2006

First Posted

September 13, 2006

Study Start

April 1, 2005

Study Completion

September 1, 2006

Last Updated

September 13, 2006

Record last verified: 2006-09

Locations

DK(1)