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NCT Number: NCT01382342

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 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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Butler Hospital

Providence, Rhode Island, 02906, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rasagiline

Drug

1 mg daily

Other names: Azilect

Placebo

Drug

1 mg daily

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Brown University

Other

Collaborators

  • Teva Pharmaceuticals USA

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jun 27, 2011
Registry last updated
Feb 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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