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Atomoxetine Treatment for Cognitive Impairment in Parkinson's Disease (ATM-Cog) (ATM-Cog)

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: NCT01738191
Recruitment Status : Completed
First Posted : November 30, 2012
Results First Posted : August 23, 2018
Last Update Posted : August 23, 2018
Sponsor:
Collaborator:
Michael J. Fox Foundation for Parkinson's Research
Information provided by (Responsible Party):
Vanessa Hinson, Medical University of South Carolina

Brief Summary:
The purpose of this study is to determine the safety and effectiveness of a drug called atomoxetine for the treatment of cognitive impairment for Parkinson 's disease. Atomoxetine (ATM) is an approved drug currently on the market for the treatment of attention deficit. It works to increase the amount of norepinephrine (a chemical in the brain that helps keep us awake and alert) in our brain. ATM has not been approved by the Food and Drug Administration (FDA) to be used in the treatment of PD.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Cognitive Impairment Drug: Atomoxetine Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Atomoxetine Treatment for Cognitive Impairment in Parkinson's Disease (ATM-Cog)
Study Start Date : November 2012
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Atomoxetine
The study drug target dose is Atomoxetine (ATM) 80 milligram (mg) per day; given as a once daily dose of an 80mg capsule. Patients will titrate up to target dose by starting on ATM 40mg capsules: 1 capsule daily for 14 days. Following study visit 3 (after 2 weeks on the titration dose), patients will increase the dose of ATM to 80mg daily.
Drug: Atomoxetine
The study drug target dose is ATM 80mg per day; given as a once daily dose of an 80mg capsule. Patients will titrate up to target dose by starting on ATM 40mg capsules: 1 capsule daily for 14 days. Following study visit 3 (after 2 weeks on the titration dose), patients will increase the dose of ATM to 80mg daily.
Other Name: Strattera

Placebo Comparator: Placebo
Patients in the placebo arm will follow the same titration schedule as those in the active arm. Patients will titrate up to target dose by starting 40mg capsules: 1 capsule daily for 14 days. Following study visit 3 (after 2 weeks on the titration dose), patients will increase the dose to 80mg daily.
Drug: Placebo



Primary Outcome Measures :
  1. The Global Statistical Test Combined Information on Change From Baseline on a Battery of Standardized Executive Function Tests [ Time Frame: change from baseline and 10 weeks ]
    Patients were ranked on each outcome and ranks were summed. The mean summed-ranks were compared by treatment group by a global statistical test (GST). Higher scores indicate better performance. The total summed-ranks range from 7 - 210 (7 outcomes x N=30).


Secondary Outcome Measures :
  1. Change in PASAT [ Time Frame: change from baseline and 10 weeks ]
    Paced Auditory Serial Addition Test 3-second interstimulus interval | Z-score| age & education normed| range -5 to +5 Higher scores mean a better outcome.

  2. Change in NAB: Part A [ Time Frame: change from baseline and 10 weeks ]

    Neuropsychological Assessment Battery Numbers & Letters A Efficiency | T-score| age & education normed| range 19-70

    Higher scores mean a better outcome.


  3. Change in NAB: Part D [ Time Frame: change from baseline and 10 weeks ]

    Neuropsychological Assessment Battery Numbers & Letters D Efficiency | T-score| age & education normed| range 19-70

    Higher scores mean a better outcome.


  4. Change in D-KEFS: Inhibition Time [ Time Frame: change from baseline and 10 weeks ]
    Delis-Kaplan Executive Function System Color-Word Inhibition Time | Scaled | age normed| range 1-16 Higher scores mean a better outcome.

  5. Change in D-KEFS: Inhibition-Switching Time [ Time Frame: change from baseline and 10 weeks ]
    Delis-Kaplan Executive Function System Color-Word Inhibition/Switching | Scaled | age normed| range 1-16 Higher scores mean a better outcome.

  6. Change in D-KEFS: Number-Letter Switching Time [ Time Frame: change from baseline and 10 weeks ]
    Delis-Kaplan Executive Function System Trail Making Number/Letter Switching | Scaled | age normed| range 1-16 Higher scores mean a better outcome.

  7. Change in WAIS-IV: Digit Span [ Time Frame: change from baseline and 10 weeks ]

    Wechsler Adult Intelligence Scale, fourth edition Digit Span | Scaled | age| 1-16

    Higher scores mean a better outcome.




Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed diagnosis of idiopathic PD according to the United Kingdom Parkinson's Disease Society Brain Bank (UKPDSBB) criteria
  • Male or female subjects aged between 35 and 75 years, inclusive at the time of consent
  • Hoehn & Yahr Stage I-IV
  • Diagnosis of PD mild cognitive impairment (MCI), Montreal Cognitive Assessment (MoCa) score 21-25
  • Stable concomitant medications for 60 days

Exclusion Criteria:

  • Secondary parkinsonism or atypical parkinsonism, Prior Deep Brain Stimulation (DBS) or other brain surgery
  • PD Dementia; MoCA score <21
  • Presence of Psychosis, pregnancy, suicidal ideation on the Columbia Suicide Severity Rating Scale (C-SSRS) type 4 or 5 in past 3 months.
  • Current treatment with anticholinergics, monoamine oxidase (MAO) inhibitors or neuroleptics (including quetiapine)
  • Serious cardiac abnormalities, Narrow angle glaucoma, Pheochromocytoma, Bipolar Disorder
  • Liver Function Tests (LFTs) >1.5 X upper limit of normal value

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): NCT01738191


Locations
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United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Michael J. Fox Foundation for Parkinson's Research
Investigators
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Principal Investigator: Vanessa K Hinson, MD, PhD Medical University of South Carolina

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Responsible Party: Vanessa Hinson, Director, Movement Disorders Program, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01738191    
Other Study ID Numbers: ATM-Cog
First Posted: November 30, 2012    Key Record Dates
Results First Posted: August 23, 2018
Last Update Posted: August 23, 2018
Last Verified: July 2018
Keywords provided by Vanessa Hinson, Medical University of South Carolina:
Parkinson's disease
Additional relevant MeSH terms:
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Parkinson Disease
Cognitive Dysfunction
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Atomoxetine Hydrochloride
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs