NCT01382342

The Effect of Rasagiline on Cognition in Parkinson's Disease

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Brown University · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Accepted

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.

Detailed description

The results of our study found that while participants receiving rasagiline showed some improvements in their motor symptoms, as measured by the UPDRS, no significant changes were found on any of the neuropsychological measures after six months of treatment with rasagiline. Further, the participant group who received placebo also did not show significant change on any of the neuropsychological measures over the six month course of our study. Finally, the cognitive performance of our treatment and placebo groups did not differ significantly from one another at baseline or after six months of study participation.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	Rasagiline	1 mg daily
DRUG	Placebo	1 mg daily

Timeline

• Start date: 2011-06-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2011-06-27
• Last updated: 2015-02-05

Locations

1 site across 1 country: United States