The Effect of Rasagiline on Cognition in Parkinson's Disease

Sponsor

Brown University (Other)

Overall Status

Completed

CT.gov ID

NCT01382342

Collaborator

Teva Pharmaceuticals USA (Industry)

Enrollment

Location

Arms

32.1

Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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:

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

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Study Start Date :

Jun 1, 2011

Actual Primary Completion Date :

Feb 1, 2014

Actual Study Completion Date :

Feb 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: rasagiline Participants in this arm will receive 1 mg of rasagiline daily for the six month duration of the study.	Drug: Rasagiline 1 mg daily Other Names: Azilect
Placebo Comparator: Placebo Participants in this group will receive 1 mg of placebo daily for the six month duration of the study.	Drug: Placebo 1 mg daily

Arm

Intervention/Treatment

Experimental: rasagiline

Participants in this arm will receive 1 mg of rasagiline daily for the six month duration of the study.

Drug: Rasagiline

1 mg daily

Other Names:

Azilect

Placebo Comparator: Placebo

Participants in this group will receive 1 mg of placebo daily for the six month duration of the study.

Drug: Placebo

1 mg daily

Outcome Measures

Primary Outcome Measures

Rey Auditory Verbal Learning Test [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.

Secondary Outcome Measures

Controlled Oral Word Association Test [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 [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 [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

age 40 or older
able to speak and read English, at least 6 years of formal education
a diagnosis of PD
have a family member or caregiver willing to fill out study questionnaires
Participants will have been on stable medication regimens (no new PD medications and no changes to existing PD medication dosages) for the 4 weeks prior to study enrollment.
If participants are already taking other Parkinson's medications at time of study enrollment, the dosages of these medications must remain stable throughout study participation.
Changes to existing Parkinson's disease medications dosages or addition of other medications to treat Parkinson's disease after study enrollment will result in removal from study.
Participants are allowed to begin non-PD medications or to have changes to their existing non-PD medications if these additions and changes are deemed medically necessary.

Exclusion Criteria:

currently taking any MAO inhibitor
currently taking a cognition-enhancing medication such as a cholinesterase inhibitor medication or memantine
dementia (Mini-Mental Status Exam score below 21/30), significant depression (Beck Depression Inventory- Short Form score >7)
presence of a another neurodegenerative disorder besides PD
unstable cardiac disorder, clinically significant hepatic
lung or renal disease
In addition, changes to dosages of PD-related medications or the addition of other PD medications during the 6 month study enrollment will result in dismissal from the study.