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Cognitive Decline in Non-demented PD

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Strattera
Exelon
Placebo
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring attention, mild cognitive impairment, dementia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Oregon Health & Science University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

atomoxetine

rivastigimine

Placebo

Arm Description

Strattera 10-30 mg b.i.d.

Exelon 1.5-4.5 mg b.i.d.

sugar pill

Outcomes

Primary Outcome Measures

Attention Network Effects

Secondary Outcome Measures

Quality of Life
PDQ-39
Stroop Color Word Test
Fatigue
Depression
Daytime Sleepiness

Full Information

First Posted
April 19, 2011
Last Updated
June 17, 2020
Sponsor
Oregon Health and Science University
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT01340885
Brief Title
Cognitive Decline in Non-demented PD
Official Title
Cognitive Dysfunction in PD: Pathophysiology and Potential Treatments, a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
attention, mild cognitive impairment, dementia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
atomoxetine
Arm Type
Active Comparator
Arm Description
Strattera 10-30 mg b.i.d.
Arm Title
rivastigimine
Arm Type
Active Comparator
Arm Description
Exelon 1.5-4.5 mg b.i.d.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
sugar pill
Intervention Type
Drug
Intervention Name(s)
Strattera
Other Intervention Name(s)
atomoxetine
Intervention Description
10-30 mg b.i.d. for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Exelon
Other Intervention Name(s)
rivastigmine
Intervention Description
1.5-4.5 mg b.i.d. for 6 weeks
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
sugar pill
Intervention Description
2-6 pills for 6 weeks
Primary Outcome Measure Information:
Title
Attention Network Effects
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Quality of Life
Description
PDQ-39
Time Frame
6 weeks
Title
Stroop Color Word Test
Time Frame
6 weeks
Title
Fatigue
Time Frame
6 weeks
Title
Depression
Time Frame
6 weeks
Title
Daytime Sleepiness
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jau-Shin Lou, MD, PhD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

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Cognitive Decline in Non-demented PD

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