Cognitive Decline in Non-demented PD
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|ClinicalTrials.gov Identifier: NCT01340885|
Recruitment Status : Unknown
Verified November 2012 by Jau-Shin Lou, Oregon Health and Science University.
Recruitment status was: Recruiting
First Posted : April 25, 2011
Last Update Posted : November 12, 2012
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease||Drug: Strattera Drug: Exelon Other: Placebo||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Cognitive Dysfunction in PD: Pathophysiology and Potential Treatments, a Pilot Study|
|Study Start Date :||January 2011|
|Estimated Primary Completion Date :||January 2013|
|Estimated Study Completion Date :||January 2013|
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
- Attention network effects [ Time Frame: 6 weeks ]
- Quality of life [ Time Frame: 6 weeks ]PDQ-39
- Stroop Color Word Test [ Time Frame: 6 weeks ]
- Fatigue [ Time Frame: 6 weeks ]
- Depression [ Time Frame: 6 weeks ]
- Daytime sleepiness [ Time Frame: 6 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01340885
|Contact: Diana Dimitrova, PhDfirstname.lastname@example.org|
|United States, Oregon|
|Oregon Health & Science University||Recruiting|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||Jau-Shin Lou, MD, PhD||Oregon Health and Science University|