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

Medical University of South Carolina (MUSC)

Status and phase: Completed; Phase 2

Conditions: Cognitive Impairment; Parkinson's Disease

Treatments: Drug: Atomoxetine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01738191

ATM-Cog

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

Atomoxetine

Active Comparator group

Description:

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.

Treatment:

Drug: Atomoxetine

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo