Cognitive Decline in Non-demented PD

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Drug: Strattera
* Drug: Exelon
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of Parkinson's disease Respond to levodopa therapy Exclusion Criteria: Dementia 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: atomoxetine<br>Strattera 10-30 mg b.i.d. | Drug: Strattera<br>* 10-30 mg b.i.d. for 6 weeks<br>* Other names: atomoxetine;|
| Active Comparator: rivastigimine<br>Exelon 1.5-4.5 mg b.i.d. | Drug: Exelon<br>* 1.5-4.5 mg b.i.d. for 6 weeks<br>* Other names: rivastigmine;|
| Placebo Comparator: Placebo<br>sugar pill | Other: Placebo<br>* 2-6 pills for 6 weeks<br>* Other names: sugar pill;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attention Network Effects |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | PDQ-39 | 6 weeks | 
| Stroop Color Word Test |  | 6 weeks | 
| Fatigue |  | 6 weeks | 
| Depression |  | 6 weeks | 
| Daytime Sleepiness |  | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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attention, mild cognitive impairment, dementia