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Completed

NCT Number: NCT01340885

Cognitive Decline in Non-demented PD

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).

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Mental Disorders Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Oregon Health & Science University

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Strattera

Drug

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

Other names: atomoxetine

Exelon

Drug

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

Other names: rivastigmine

Placebo

Other

2-6 pills for 6 weeks

Other names: sugar pill

Primary outcomes

  1. Attention Network Effects

    Time frame: 6 weeks

Secondary outcomes

  1. Quality of Life

    Time frame: 6 weeks

    PDQ-39

  2. Stroop Color Word Test

    Time frame: 6 weeks

  3. Fatigue

    Time frame: 6 weeks

  4. Depression

    Time frame: 6 weeks

  5. Daytime Sleepiness

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Apr 25, 2011
Registry last updated
Jul 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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