Phase 2 N=30 Randomized Double-blind Treatment

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

Parkinson's Disease · Cognitive Impairment

Bottom Line

View on ClinicalTrials.gov: NCT01738191 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2018

Primary outcome: Primary: The Global Statistical Test Combined Information on Change From Baseline on a Battery of Standardized Executive Function Tests — 99.5; 117.5 summed-ranks — p=0.25

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Atomoxetine (Drug); Placebo (Drug)
Age: Adult, Older Adult · 35+ yrs
Sex: All
Sponsor: Medical University of South Carolina
Primary completion: Aug 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY The Global Statistical Test Combined Information on Change From Baseline on a Battery of Standardized Executive Function Tests	99.5; 117.5	0.25
SECONDARY Change in PASAT	-0.96; 0.42	—
SECONDARY Change in NAB: Part A	-0.71; -0.23	—
SECONDARY Change in NAB: Part D	-0.35; -0.11	—
SECONDARY Change in D-KEFS: Inhibition Time	-0.77; -0.3	—
SECONDARY Change in D-KEFS: Inhibition-Switching Time	-0.87; -0.2	—
SECONDARY Change in D-KEFS: Number-Letter Switching Time	-0.9; -0.67	—
SECONDARY Change in WAIS-IV: Digit Span	-0.17; 0	—

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 1.5 X upper limit of normal value

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01738191). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.