Cognitive Decline in Non-demented PD

June 17, 2020 updated by: Jau-Shin Lou, Oregon Health and Science University

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

9

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
sugar pill
Other: Placebo
2-6 pills for 6 weeks
Other Names:
  • sugar pill
ACTIVE_COMPARATOR: atomoxetine
Strattera 10-30 mg b.i.d.
Drug: Strattera
10-30 mg b.i.d. for 6 weeks
Other Names:
  • atomoxetine
ACTIVE_COMPARATOR: rivastigimine
Exelon 1.5-4.5 mg b.i.d.
Drug: Exelon
1.5-4.5 mg b.i.d. for 6 weeks
Other Names:
  • rivastigmine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Attention Network Effects
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life
Time Frame: 6 weeks
PDQ-39
6 weeks
Stroop Color Word Test
Time Frame: 6 weeks
6 weeks
Fatigue
Time Frame: 6 weeks
6 weeks
Depression
Time Frame: 6 weeks
6 weeks
Daytime Sleepiness
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (ACTUAL)

January 1, 2013

Study Completion (ACTUAL)

January 1, 2013

Study Registration Dates

First Submitted

April 19, 2011

First Submitted That Met QC Criteria

April 21, 2011

First Posted (ESTIMATE)

April 25, 2011

Study Record Updates

Last Update Posted (ACTUAL)

July 7, 2020

Last Update Submitted That Met QC Criteria

June 17, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PANUC - Lou
  • 5P50NS062684-02 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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