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NCT00094601 · ClinicalTrials.gov registry record
Relationship of Dopamine to Cognitive Function in Parkinson's Disease
A clinical trial, sponsored by National Institute of Mental Health (NIMH).
- Completed
- Registry status
- 75
- Enrollment target
NCT00094601: Completed study, sponsored by National Institute of Mental Health (NIMH).
NCT00094601 is a clinical trial that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 75 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00094601 has completed, sponsored by National Institute of Mental Health (NIMH).
- COMPLETED
- Registry status
- 75 participants
- Enrollment target
Study Summary
This study will examine how the brain chemical dopamine affects memory, reasoning, and other thought processes in people with Parkinson's disease with and without dementia and in healthy control subjects. Healthy normal volunteers and people with Parkinson's disease who are between 40 and 85 years of age may be eligible for this study. Pregnant women with Parkinson's disease and breastfeeding normal volunteers are excluded. Candidates are screened with a physical and neurological examination, blood tests, a brief mental test called the Mini Mental Status Examination, and other tests designed to assess memory, learning, reasoning, and other thought processes. Patients with Parkinson's disease also undergo a more thorough mental evaluation called the Mattis Dementia Rating Scale. The study requires about 15 hours over 4 or 5 outpatient visits to NIH. Participants undergo two positron emission tomography (PET) scans on two separate days and a magnetic resonance imaging (MRI) scan, as follows: PET Scans The two PET procedures are done the same way, except one uses a radioactive tracer called \[(18)F\]DOPA and one uses a tracer called \[(11)C\]NNC-112. A catheter (small plastic tube) is placed in a vein in the subject's arm for injection of the tracer. The subject lies on the scanner bed and a special mask is fitted to his or her head to hold it in place during the procedure. Just before injecting the tracer, a 10-minute "transmission scan" is done of the head using a tracer called (68)Ge. Then, a series of scans using one of the two study tracers (\[(18)F\]DOPA or \[(11)C\]NNC-112 are done for about 90 minutes. About 1 hour before injection of the \[(18)F\]DOPA tracer, subjects take 200 mg of the drug carbidopa by mouth to help the tracer work properly. Blood pressure, breathing and heart are monitored before and after injection of the \[(11)C\]NNC-112 tracer. Patients with Parkinson's disease are taken off all Parkinson's medications the night before the \[(18)F\]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2004-10-18 |
| Est. Completion | 2008-01-22 |
What the finished NCT00094601 record still lists
NCT00094601 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 75 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT00094601 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00094601 about?
NCT00094601 is a clinical study titled "Relationship of Dopamine to Cognitive Function in Parkinson's Disease". This study will examine how the brain chemical dopamine affects memory, reasoning, and other thought processes in people with Parkinson's disease with and without dementia and in healthy control subjects. Healthy normal volunteers and people with Parkinson's disease who are between 40 and 85 years ...
What is the current status of trial NCT00094601?
This trial is currently completed. The enrollment target is 75 participants. The study started on 2004-10-18. Estimated completion is 2008-01-22.
Who is sponsoring clinical trial NCT00094601?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
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