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Trial record 2 of 3 for:    atomoxetine and Mild cognitive impairment

Cognitive Decline in Non-demented PD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01340885
Recruitment Status : Unknown
Verified November 2012 by Jau-Shin Lou, Oregon Health and Science University.
Recruitment status was:  Recruiting
First Posted : April 25, 2011
Last Update Posted : November 12, 2012
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Jau-Shin Lou, Oregon Health and Science University

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).

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: Strattera Drug: Exelon Other: Placebo Phase 4

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  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive Dysfunction in PD: Pathophysiology and Potential Treatments, a Pilot Study
Study Start Date : January 2011
Estimated Primary Completion Date : January 2013
Estimated Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Attention network effects [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01340885


Contacts
Contact: Diana Dimitrova, PhD 503-494-7269 dimitrov@ohsu.edu

Locations
United States, Oregon
Oregon Health & Science University Recruiting
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

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 ( U.S. NIH Grant/Contract )
First Posted: April 25, 2011    Key Record Dates
Last Update Posted: November 12, 2012
Last Verified: November 2012

Keywords provided by Jau-Shin Lou, 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
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cholinesterase Inhibitors
Enzyme Inhibitors
Cholinergic Agents
Neuroprotective Agents
Protective Agents