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NCT01382342 · ClinicalTrials.gov registry record · Phase 4
The Effect of Rasagiline on Cognition in Parkinson's Disease
A Phase 4 study of Parkinson's Disease, sponsored by Brown University.
- Completed
- Registry status
- Phase 4
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT01382342 is a Phase 4 study of Parkinson's Disease that has completed, run by Brown University. The registered enrollment target is 50 participants, below the 642-participant average among 156 other Parkinson's Disease trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01382342, a Phase 4 study of Parkinson's Disease, has completed, sponsored by Brown University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
While Parkinson's disease has historically been defined in terms of its motor symptomatology, studies have shown that non-motor deficits form an important part of the syndrome. Cognitive deficits can occur even in the early stages of Parkinson's disease. These deficits are often subtle and do not rise to the level of impairment necessary for a diagnosis of dementia; however these deficits are discernable with neuropsychological testing and may produce subjective complaints of cognitive decline and mild functional difficulties in some patients. The traditional pharmacological interventions for Parkinson's disease have focused on controlling and alleviating motor symptoms with levodopa and dopamine agonists. However, these medications treat the symptoms of PD, but do not alter the course or progression of the underlying disorder. In contrast, rasagiline, an MAO-B inhibitor, has recently shown benefits consistent with a possible disease-modifying effect. Given the positive and intriguing findings seen with treatment with rasagiline, the investigators propose to study the effects of this medication on cognition in patients with mild to moderate stage Parkinson's disease. Hypotheses: 1. Rasagiline will improve cognitive function, as measured by performance on neuropsychological tests in PD patients who do not suffer from dementia. 2. Rasagiline will not negatively affect neuropsychiatric functioning.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Rasagiline
Study Locations (1)
Rhode Island
- Butler Hospital - Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2011-06 |
| Est. Completion | 2014-02 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01382342
The ClinicalTrials.gov registry entry for NCT01382342 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 642-participant average among 156 other Parkinson's Disease trials with a reported enrollment target (92% lower). The listed sponsor is Brown University, which has 231 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Parkinson's Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01382342 reports 1 study location spanning 1 distinct geographic area - top geographies include Rhode Island.
Frequently Asked Questions
What is clinical trial NCT01382342 about?
NCT01382342 is a clinical study titled "The Effect of Rasagiline on Cognition in Parkinson's Disease". While Parkinson's disease has historically been defined in terms of its motor symptomatology, studies have shown that non-motor deficits form an important part of the syndrome. Cognitive deficits can occur even in the early stages of Parkinson's disease. These deficits are often subtle and do not ri...
What is the current status of trial NCT01382342?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 50 participants. The study started on 2011-06. Estimated completion is 2014-02.
What conditions does trial NCT01382342 study?
This clinical trial studies the following conditions: Parkinson's Disease.
What interventions are being tested in trial NCT01382342?
The interventions under investigation include: Placebo (DRUG), Rasagiline (DRUG).
Who is sponsoring clinical trial NCT01382342?
This trial is sponsored by Brown University, which has 231 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01382342 being conducted?
This trial has 1 study location across Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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