The Effect of Rasagiline on Cognition in Parkinson's Disease
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|ClinicalTrials.gov Identifier: NCT01382342|
Recruitment Status : Completed
First Posted : June 27, 2011
Last Update Posted : February 5, 2015
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.
- Rasagiline will improve cognitive function, as measured by performance on neuropsychological tests in PD patients who do not suffer from dementia.
- Rasagiline will not negatively affect neuropsychiatric functioning.
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease||Drug: Rasagiline Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||February 2014|
Participants in this arm will receive 1 mg of rasagiline daily for the six month duration of the study.
1 mg daily
Other Name: Azilect
Placebo Comparator: Placebo
Participants in this group will receive 1 mg of placebo daily for the six month duration of the study.
1 mg daily
- Rey Auditory Verbal Learning Test [ Time Frame: Change in score from day 1 of study enrollment and score after 6 months of treatment ]This is a 15 item supraspan verbal memory test. This measure assesses immediate memory span, new learning, susceptibility to interference, retention, and recognition memory.
- Controlled Oral Word Association Test [ Time Frame: day 1 of study enrollment and after 6 months of treatment ]This test evaluates the spontaneous production of words beginning with a given letter of the alphabet under timed conditions. It is used to assess executive functioning.
- Animal Fluency [ Time Frame: day 1 of study enrollment and after 6 months of treatment ]Participants are asked to produce as many animal names as they can in one minute. This measure assesses executive functioning.
- Judgement of Line Orientation from the Repeat Battery for the Assessment of Neuropsychological Status [ Time Frame: day 1 of study enrollment and after 6 months of treatment ]This measure assesses spatial perception and orientation without requiring a motor output.
- Digit Span from the Wechsler Adult Intelligence Scale- Fourth Edition [ Time Frame: day 1 of study enrollment and after 6 months of treatment ]This is a measure of attention and working memory which requires participants to repeat a series of digits forward, in reverse, and to sequence a series of digits.
- Trail Making Test [ Time Frame: day 1 of study enrollment and after 6 months of treatment ]These are tests of speed for attention, sequencing, mental flexibility, and visual search.
- Digit Symbol Modalities Test [ Time Frame: day 1 of study enrollment and after 6 months of treatment ]This test assesses cognitive processing speed, and visuomotor coordination and is one of the most sensitive measures of cognitive dysfunction available.
- Parkinson's Disease Quality of Life Questionnaire [ Time Frame: day 1 of study enrollment and after 6 months of treatment ]The 39-item Parkinson's disease questionnaire (PDQ-39) is one of the most often used instruments to measure treat¬ment effect on quality of life in PD.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01382342
|United States, Rhode Island|
|Providence, Rhode Island, United States, 02906|
|Principal Investigator:||Laura L. Frakey, Ph.D.||Brown University|
|Principal Investigator:||Joseph Friedman, MD||Brown University|