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

NCT01738191 | Completed Phase 2 Results DMC

• 1 other identifier: ATM-Cog
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease; Cognitive Impairment

Keywords

Parkinson's disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change in PASAT

  change from baseline and 10 weeks

• Change in NAB: Part A

  change from baseline and 10 weeks

• Change in NAB: Part D

  change from baseline and 10 weeks

• Change in D-KEFS: Inhibition Time

  change from baseline and 10 weeks

• Change in D-KEFS: Inhibition-Switching Time

  change from baseline and 10 weeks

Study Arms (2)

Atomoxetine

ACTIVE COMPARATOR

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.

Drug: Atomoxetine

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Atomoxetine DRUG

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.

Also known as: Strattera

Atomoxetine

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Michael J. Fox Foundation for Parkinson's Research: collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Cognitive Dysfunction

Interventions

Atomoxetine Hydrochloride

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Results Point of Contact

• Title: Dr. Vanessa Hinson
• Organization: Medical University of South Carolina

hinsonvk@musc.edu

843-792-9115

Study Officials

• Vanessa K Hinson, MD, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Movement Disorders Program

Study Record Dates

• First Submitted: November 28, 2012
• First Posted: November 30, 2012
• Study Start: November 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: August 23, 2018
• Results First Posted: August 23, 2018

Record last verified: 2018-07

Locations

US (1)