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

• Status: Completed
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of South Carolina
• Collaborator: Michael J. Fox Foundation for Parkinson's Research
• Treatments: Atomoxetine Hydrochloride

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