Cognitive Decline in Non-demented PD
Recruitment status was: Recruiting
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Cognitive Dysfunction in PD: Pathophysiology and Potential Treatments, a Pilot Study|
- Attention network effects [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Quality of life [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]PDQ-39
- Stroop Color Word Test [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Fatigue [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Depression [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Daytime sleepiness [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||January 2013|
|Estimated Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
Active Comparator: atomoxetine
Strattera 10-30 mg b.i.d.
10-30 mg b.i.d. for 6 weeks
Other Name: atomoxetine
Active Comparator: rivastigimine
Exelon 1.5-4.5 mg b.i.d.
1.5-4.5 mg b.i.d. for 6 weeks
Other Name: rivastigmine
Placebo Comparator: Placebo
2-6 pills for 6 weeks
Other Name: sugar pill
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01340885
|United States, Oregon|
|Oregon Health & Science University|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||Jau-Shin Lou, MD, PhD||Oregon Health and Science University|