Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effect of Rasagiline on Cognition in Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01382342
Recruitment Status : Completed
First Posted : June 27, 2011
Last Update Posted : February 5, 2015
Sponsor:
Collaborator:
Teva Pharmaceuticals USA
Information provided by (Responsible Party):
Laura L. Frakey, Brown University

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:

  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.

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : June 2011
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine


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 Name: 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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

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


Locations
Layout table for location information
United States, Rhode Island
Butler Hospital
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
Brown University
Teva Pharmaceuticals USA
Investigators
Layout table for investigator information
Principal Investigator: Laura L. Frakey, Ph.D. Brown University
Principal Investigator: Joseph Friedman, MD Brown University

Layout table for additonal information
Responsible Party: Laura L. Frakey, Clinical Neuropsychologist, Brown University
ClinicalTrials.gov Identifier: NCT01382342    
Other Study ID Numbers: TNSAZL0016
First Posted: June 27, 2011    Key Record Dates
Last Update Posted: February 5, 2015
Last Verified: February 2015
Keywords provided by Laura L. Frakey, Brown University:
Parkinson's disease
cognition
executive function
rasagiline
Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Rasagiline
Monoamine Oxidase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs