Atomoxetine Treatment for Cognitive Impairment in Parkinson's Disease (ATM-Cog) (ATM-Cog)
Parkinson's Disease, Cognitive Impairment
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease
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
Sites / Locations
- Medical University of South Carolina
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Atomoxetine
Placebo
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.
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.