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

Overview

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.

Full Title of Study: “Atomoxetine Treatment for Cognitive Impairment in Parkinson’s Disease (ATM-Cog)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: August 2014

Interventions

  • 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.
  • Drug: Placebo

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 35 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Medical University of South Carolina
  • Collaborator
    • Michael J. Fox Foundation for Parkinson’s Research
  • Provider of Information About this Clinical Study
    • Principal Investigator: Vanessa Hinson, Director, Movement Disorders Program – Medical University of South Carolina
  • Overall Official(s)
    • Vanessa K Hinson, MD, PhD, Principal Investigator, Medical University of South Carolina

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