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Completed

NCT Number: NCT01738191

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

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.

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Key information

Conditions

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

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Atomoxetine

Drug

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 names: Strattera

Placebo

Drug

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • Michael J. Fox Foundation for Parkinson's Research

Registry information

Acronym: ATM-Cog

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Nov 30, 2012
Registry last updated
Aug 23, 2018

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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