Atomoxetine Treatment for Cognitive Impairment in Parkinson's Disease (ATM-Cog)
Completed · Phase 2 · Has a placebo group
Conditions studied: Parkinson's Disease, Cognitive Impairment
In brief
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.
Key facts
- Study ID
- NCT01738191
- Run by
- Medical University of South Carolina
- People needed
- 30
- Starts
- 2012-11-01
- Expected to finish
- 2014-08-01
- Last updated by the study team
- 2018-08-23
Who can join
Age: 35 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Medical University of South Carolina — Charleston, South Carolina, United States
Full record on ClinicalTrials.gov
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