Cognitive Decline in Non-demented PD

NCT ID: NCT01340885

Last Updated: 2020-07-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-01-31

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.

Conditions

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Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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atomoxetine

Strattera 10-30 mg b.i.d.

Group Type ACTIVE_COMPARATOR

Strattera

Intervention Type DRUG

10-30 mg b.i.d. for 6 weeks

rivastigimine

Exelon 1.5-4.5 mg b.i.d.

Group Type ACTIVE_COMPARATOR

Exelon

Intervention Type DRUG

1.5-4.5 mg b.i.d. for 6 weeks

Placebo

sugar pill

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

2-6 pills for 6 weeks

Interventions

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Strattera

10-30 mg b.i.d. for 6 weeks

Intervention Type DRUG

Exelon

1.5-4.5 mg b.i.d. for 6 weeks

Intervention Type DRUG

Placebo

2-6 pills for 6 weeks

Intervention Type OTHER

Other Intervention Names

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atomoxetine rivastigmine sugar pill

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role collaborator

Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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Jau-Shin Lou

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jau-Shin Lou, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

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Oregon Health & Science University

Portland, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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5P50NS062684-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PANUC - Lou

Identifier Type: -

Identifier Source: org_study_id

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