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

Medical University of South Carolina30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Parkinson's Disease Cognitive Impairment

Interventions

AtomoxetineDRUG

The study drug target dose is ATM 80mg 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.

PlaceboDRUG

Eligibility

Sex: ALLMin age: 35 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Medical University of South Carolina

Charleston, South Carolina, United States

Outcomes

Primary Outcomes

The Global Statistical Test Combined Information on Change From Baseline on a Battery of Standardized Executive Function Tests

Patients were ranked on each outcome and ranks were summed. The mean summed-ranks were compared by treatment group by a global statistical test (GST). Higher scores indicate better performance. The total summed-ranks range from 7 - 210 (7 outcomes x N=30).