Cognitive Decline in Non-demented PD

Phase 4

Completed

• Conditions: Parkinson's Disease
• Interventions: Drug: Strattera; Drug: Exelon; Other: Placebo

• Registration Number: NCT01340885
• Lead Sponsor: Oregon Health and Science University

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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-04-19
• Study First Submitted QC: 2011-04-21
• Study First Posted: 2011-04-25
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2020-06
• Results First Submitted: 2020-06-17
• Results First Submitted QC: 2020-06-17
• Last Update Submitted: 2020-06-17
• Results First Posted: 2020-07-07
• Last Update Posted: 2020-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
atomoxetine	Strattera	Strattera 10-30 mg b.i.d.
rivastigimine	Exelon	Exelon 1.5-4.5 mg b.i.d.
Placebo	Placebo	sugar pill

Primary Outcome Measures

Name	Time	Method
Attention Network Effects	6 weeks

Secondary Outcome Measures

Name	Time	Method
Depression	6 weeks
Daytime Sleepiness	6 weeks
Quality of Life	6 weeks	PDQ-39
Fatigue	6 weeks
Stroop Color Word Test	6 weeks

Trial Locations

Locations (1)

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States