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Clinical Trials/NCT01340885
NCT01340885
Completed
Phase 4

Cognitive Dysfunction in PD: Pathophysiology and Potential Treatments, a Pilot Study

Oregon Health and Science University1 site in 1 country9 target enrollmentJanuary 2011

Overview

Phase
Phase 4
Intervention
Placebo
Conditions
Parkinson's Disease
Sponsor
Oregon Health and Science University
Enrollment
9
Locations
1
Primary Endpoint
Attention Network Effects
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The purpose of this study is to determine the relationship between attention and quality of life and how rivastigmine and atomoxetine alter attention in non-demented persons with Parkinson's disease (PD).

Detailed Description

Cognitive dysfunction can occur in early stage of Parkinson's disease (PD) and increases as PD progresses. Attention deficits in PD patients with dementia strongly predict the impairment of their daily living activities. Previous studies have shown that atomoxetine improves PD executive dysfunction and rivastigmine improves attention deficits in PD patients with dementia without worsening the motor symptoms. The aim of this study is to examine the effect of atomoxetine and rivastigmine on attention and quality of life in PD patients without disabling cognitive impairment.

Registry
clinicaltrials.gov
Start Date
January 2011
End Date
January 2013
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jau-Shin Lou

Associate Professor

Oregon Health and Science University

Eligibility Criteria

Inclusion Criteria

  • Clinical diagnosis of Parkinson's disease
  • Respond to levodopa therapy

Exclusion Criteria

  • Psychiatric disorders including anxiety disorders, dissociative disorders, mood disorders, schizophrenia and related disorders, or ADD/ADHD
  • Any clinically unstable disease such as cancer, HIV/AIDS, heart condition, liver disease, kidney or renal failure or others that might require hospitalization
  • Evidence for another neurological disease (history of seizures, Alzheimer disease, multiple sclerosis or other movement disorders);
  • Currently using any of the study drugs;
  • Colorblindness

Arms & Interventions

Placebo

sugar pill

Intervention: Placebo

atomoxetine

Strattera 10-30 mg b.i.d.

Intervention: Strattera

rivastigimine

Exelon 1.5-4.5 mg b.i.d.

Intervention: Exelon

Outcomes

Primary Outcomes

Attention Network Effects

Time Frame: 6 weeks

Secondary Outcomes

  • Depression(6 weeks)
  • Daytime Sleepiness(6 weeks)
  • Quality of Life(6 weeks)
  • Fatigue(6 weeks)
  • Stroop Color Word Test(6 weeks)

Study Sites (1)

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