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

Parkinson's Disease Clinical Trial

— ATM-Cog  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01738191
• Other study ID #: ATM-Cog
• Status: Completed
• Phase: Phase 2
• Start date: November 2012
• Est. completion date: August 2014

Study information

• Verified date: July 2018
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• Atomoxetine
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.
• Placebo

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	Michael J. Fox Foundation for Parkinson's Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	change from baseline and 10 weeks
Secondary	Change in PASAT	Paced Auditory Serial Addition Test 3-second interstimulus interval | Z-score| age & education normed| range -5 to +5 Higher scores mean a better outcome.	change from baseline and 10 weeks
Secondary	Change in NAB: Part A	Neuropsychological Assessment Battery Numbers & Letters A Efficiency | T-score| age & education normed| range 19-70; Higher scores mean a better outcome.	change from baseline and 10 weeks
Secondary	Change in NAB: Part D	Neuropsychological Assessment Battery Numbers & Letters D Efficiency | T-score| age & education normed| range 19-70; Higher scores mean a better outcome.	change from baseline and 10 weeks
Secondary	Change in D-KEFS: Inhibition Time	Delis-Kaplan Executive Function System Color-Word Inhibition Time | Scaled | age normed| range 1-16 Higher scores mean a better outcome.	change from baseline and 10 weeks
Secondary	Change in D-KEFS: Inhibition-Switching Time	Delis-Kaplan Executive Function System Color-Word Inhibition/Switching | Scaled | age normed| range 1-16 Higher scores mean a better outcome.	change from baseline and 10 weeks
Secondary	Change in D-KEFS: Number-Letter Switching Time	Delis-Kaplan Executive Function System Trail Making Number/Letter Switching | Scaled | age normed| range 1-16 Higher scores mean a better outcome.	change from baseline and 10 weeks
Secondary	Change in WAIS-IV: Digit Span	Wechsler Adult Intelligence Scale, fourth edition Digit Span | Scaled | age| 1-16; Higher scores mean a better outcome.	change from baseline and 10 weeks