Cognitive Decline in Non-demented PD

This study is currently recruiting participants.

Verified November 2012 by Oregon Health and Science University

Sponsor:

Collaborator:

National Institute of Neurological Disorders and Stroke (NINDS)

Information provided by (Responsible Party):

Jau-Shin Lou, Oregon Health and Science University

ClinicalTrials.gov Identifier:

NCT01340885

First received: April 19, 2011

Last updated: November 9, 2012

Last verified: November 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

April 19, 2011

Last Updated Date

November 9, 2012

Start Date ^ICMJE

January 2011

Estimated Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Attention network effects [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01340885 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Cognitive Decline in Non-demented PD

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Parkinson's Disease

Intervention ^ICMJE

Drug: Strattera
10-30 mg b.i.d. for 6 weeks

Other Name: atomoxetine
Drug: Exelon
1.5-4.5 mg b.i.d. for 6 weeks

Other Name: rivastigmine
Other: Placebo
2-6 pills for 6 weeks

Other Name: sugar pill

Study Arm (s)

Active Comparator: atomoxetine
Strattera 10-30 mg b.i.d.

Intervention: Drug: Strattera
Active Comparator: rivastigimine
Exelon 1.5-4.5 mg b.i.d.

Intervention: Drug: Exelon
Placebo Comparator: Placebo
sugar pill

Intervention: Other: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

January 2013

Estimated Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Diana Dimitrova, PhD

503-494-7269

dimitrov@ohsu.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01340885

Other Study ID Numbers ^ICMJE

PANUC - Lou, 5P50NS062684-02

Has Data Monitoring Committee

Responsible Party

Jau-Shin Lou, Oregon Health and Science University

Study Sponsor ^ICMJE

Oregon Health and Science University

Collaborators ^ICMJE

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators ^ICMJE

Principal Investigator:

Jau-Shin Lou, MD, PhD

Oregon Health and Science University

Information Provided By

Oregon Health and Science University

Verification Date

November 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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