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Trial record 2 of 4 for:    atomoxetine and Mild cognitive impairment

Cognitive Decline in Non-demented PD

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2012 by Oregon Health and Science University.
Recruitment status was:  Recruiting
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
  Purpose
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).

Condition Intervention Phase
Parkinson's Disease
Drug: Strattera
Drug: Exelon
Other: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive Dysfunction in PD: Pathophysiology and Potential Treatments, a Pilot Study

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Attention network effects [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: January 2011
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: atomoxetine
Strattera 10-30 mg b.i.d.
Drug: Strattera
10-30 mg b.i.d. for 6 weeks
Other Name: 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 Name: rivastigmine
Placebo Comparator: Placebo
sugar pill
Other: Placebo
2-6 pills for 6 weeks
Other Name: sugar pill

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01340885

Locations
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: Jau-Shin Lou, MD, PhD Oregon Health and Science University
  More Information

Responsible Party: Jau-Shin Lou, Associate Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01340885     History of Changes
Other Study ID Numbers: PANUC - Lou  5P50NS062684-02 
Study First Received: April 19, 2011
Last Updated: November 9, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
attention
mild cognitive impairment
dementia

Additional relevant MeSH terms:
Atomoxetine Hydrochloride
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Rivastigmine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Adrenergic Agents

ClinicalTrials.gov processed this record on December 02, 2016