The Effect of Rasagiline on Cognition in Parkinson's Disease

NCT01382342 | Completed Phase 4

• 1 other identifier: TNSAZL0016
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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. 1.Rasagiline will improve cognitive function, as measured by performance on neuropsychological tests in PD patients who do not suffer from dementia.
2. 2.Rasagiline will not negatively affect neuropsychiatric functioning.

Conditions

Parkinson's Disease

Keywords

Parkinson's disease; cognition; executive function; rasagiline

Outcome Measures

Primary Outcomes (1)

• Rey Auditory Verbal Learning Test

  This is a 15 item supraspan verbal memory test. This measure assesses immediate memory span, new learning, susceptibility to interference, retention, and recognition memory.

  Change in score from day 1 of study enrollment and score after 6 months of treatment

Secondary Outcomes (7)

• Controlled Oral Word Association Test

  day 1 of study enrollment and after 6 months of treatment

• Animal Fluency

  day 1 of study enrollment and after 6 months of treatment

• 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

• Digit Span from the Wechsler Adult Intelligence Scale- Fourth Edition

  day 1 of study enrollment and after 6 months of treatment

• Trail Making Test

  day 1 of study enrollment and after 6 months of treatment

Study Arms (2)

rasagiline

EXPERIMENTAL

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

Drug: Rasagiline

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Rasagiline DRUG

1 mg daily

Also known as: Azilect

rasagiline

Placebo DRUG

1 mg daily

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brown University: lead
• Teva Pharmaceuticals USA: collaborator

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

rasagiline

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Laura L. Frakey, Ph.D.

  Brown University

  PRINCIPAL INVESTIGATOR

• Joseph Friedman, MD

  Brown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Neuropsychologist

Study Record Dates

• First Submitted: June 23, 2011
• First Posted: June 27, 2011
• Study Start: June 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: February 5, 2015

Record last verified: 2015-02

Locations

US (1)