Atomoxetine Treatment for Cognitive Impairment in Parkinson's Disease (ATM-Cog)
| Status: | Completed |
|---|---|
| Conditions: | Cognitive Studies, Parkinsons Disease |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 35 - 75 |
| Updated: | 8/25/2018 |
| Start Date: | November 2012 |
| End Date: | August 2014 |
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.
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.
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
We found this trial at
1
site
171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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