Clinical trial NCT01738191: Atomoxetine Treatment for Cognitive Impairment in Parkinson's Disease (ATM-Cog)
Official title: Atomoxetine Treatment for Cognitive Impairment in Parkinson's Disease (ATM-Cog)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson's Disease
Cognitive Impairment
Keywords: Parkinson's disease
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: Michael J. Fox Foundation for Parkinson's Research
First posted: 2012-11-30
Enrollment: 30
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: The Global Statistical Test Combined Information on Change From Baseline on a Battery of Standardized Executive Function Tests
timeFrame: change from baseline and 10 weeks
Secondary outcomes:
measure: Change in PASAT
timeFrame: change from baseline and 10 weeks
measure: Change in NAB: Part A
timeFrame: change from baseline and 10 weeks
measure: Change in NAB: Part D
timeFrame: change from baseline and 10 weeks
measure: Change in D-KEFS: Inhibition Time
timeFrame: change from baseline and 10 weeks
measure: Change in D-KEFS: Inhibition-Switching Time
timeFrame: change from baseline and 10 weeks
measure: Change in D-KEFS: Number-Letter Switching Time
timeFrame: change from baseline and 10 weeks
measure: Change in WAIS-IV: Digit Span
timeFrame: change from baseline and 10 weeks
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Vanessa K Hinson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: