Parkinson's DiseaseNCT00375778
Parkinson's Disease Evaluated by PET and the Effect of Memantine
A study testing memantine (drug) in people with Parkinson's Disease, run by University of Aarhus at 1 site in Denmark.
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). Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- memantine (drug)
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2005to Sep 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parkinson's Disease (British Brain Bank Criteria)
- Age 50-70y
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Parkinson's Disease Evaluated by Positron Emission Tomography and the Effect of the NMDA Receptor Antagonist Memantine
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.
- Conditions
- Parkinson's Disease
- Being tested
- memantine (drug)
- Keywords
- Parkinson's Disease, Positron Emission Tomography, Memantine, NMDA antagonists, Cerebral Blood Flow, Cerebral Metabolic Rate of Oxygen
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
memantine (drug)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2006 (estimated)
- Study startApr 2005
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Lundbeck Foundation
- Investigators
- Karen Ostergaard, MD, Ph.D, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00375778
- Sponsor's protocol ID
- 2004-004139-74
- Other IDs
- 2004
- Status last verified
- Sep 2006
- First submitted
- 12 Sep 2006
- Last updated
- 13 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parkinson's Disease Evaluated by Positron Emission Tomography and the Effect of the NMDA Receptor Antagonist Memantine
- ClinicalTrials.gov ID
- NCT00375778
- Acronym / sponsor ID
- 2004-004139-74
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's Disease, Positron Emission Tomography, Memantine, NMDA antagonists, Cerebral Blood Flow, Cerebral Metabolic Rate of Oxygen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Lundbeck Foundation
- Study start
- Apr 2005
- Study completion
- Sep 2006
- First posted
- 13 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Parkinson's Disease (British Brain Bank Criteria)
- Age 50-70y
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| memantine (drug) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Ostergaard, MD, Ph.D principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing memantine (drug) in people with Parkinson's Disease, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2006.