Atomoxetine Treatment for Cognitive Impairment in Parkinson's Disease (ATM-Cog)
Overview
- Phase
- Phase 2
- Intervention
- Atomoxetine
- Conditions
- Parkinson's Disease
- Sponsor
- Medical University of South Carolina
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- The Global Statistical Test Combined Information on Change From Baseline on a Battery of Standardized Executive Function Tests
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Vanessa Hinson
Director, Movement Disorders Program
Medical University of South Carolina
Eligibility 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
Arms & Interventions
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.
Intervention: Atomoxetine
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.
Intervention: Placebo
Outcomes
Primary Outcomes
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
- Change in D-KEFS: Inhibition-Switching Time(change from baseline and 10 weeks)
- Change in WAIS-IV: Digit Span(change from baseline and 10 weeks)
- Change in PASAT(change from baseline and 10 weeks)
- Change in NAB: Part D(change from baseline and 10 weeks)
- Change in D-KEFS: Number-Letter Switching Time(change from baseline and 10 weeks)
- Change in NAB: Part A(change from baseline and 10 weeks)
- Change in D-KEFS: Inhibition Time(change from baseline and 10 weeks)