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

This study has been completed.
Sponsor:
Collaborator:
Michael J. Fox Foundation for Parkinson's Research
Information provided by (Responsible Party):
Vanessa Hinson, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01738191
First received: November 28, 2012
Last updated: March 14, 2016
Last verified: March 2016
  Purpose
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.

Condition Intervention Phase
Parkinson's Disease
Cognitive Impairment
Drug: Atomoxetine
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Atomoxetine Treatment for Cognitive Impairment in Parkinson's Disease (ATM-Cog)

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • Neuropsychological Testing Battery [ Time Frame: twice within 12 week period ] [ Designated as safety issue: No ]
    To examine in a 12-week, single-site, parallel, randomized, double-blind, placebo-controlled trial the efficacy of Atomoxetine (ATM) for the treatment of attention, set-shifting, information processing speed and working memory deficits in cognitively impaired, non-demented patients with Parkinson's disease (PD). The primary outcome for this study is the Global Treatment effect (GTE) at 10 weeks of combined ATM sensitive neuropsychological measures. Secondary outcomes are a set of neuropsychological measures that we hypothesize are not sensitive to treatment with ATM.


Secondary Outcome Measures:
  • Safety measures [ Time Frame: 5 visits throughout 12 weeks ] [ Designated as safety issue: Yes ]
    To examine the safety of ATM in patients with PD. Safety will be determined through assessments of Vital Signs, Unified Parkinson's Disease Rating Scale (UPDRS), adverse events, Non-Motor Symptoms Scale (NMSS), comprehensive metabolic panel (CMP), and electrocardiogram (ECG).


Other Outcome Measures:
  • Clinical predictors [ Time Frame: Throughout 12 week time period ] [ Designated as safety issue: No ]

    To examine clinical predictors of response to ATM therapy. We will examine four groups of baseline predictors of outcome on the above primary measures:

    Cognitive impairment [Montreal Cognitive Assessment (MoCA) score], PD motor symptoms [Unified Parkinson's Disease Rating Scale (UPDRS)], Quality of life [39 item Parkinson's Disease Questionnaire (PDQ-39)], and Mood disturbance [Geriatric Depression Scale (GDS)], [Geriatric Anxiety Inventory (GAI)].



Enrollment: 30
Study Start Date: November 2012
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Atomoxetine
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
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.
Other Name: Strattera
Placebo Comparator: Placebo
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

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 <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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01738191

Locations
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Michael J. Fox Foundation for Parkinson's Research
Investigators
Principal Investigator: Vanessa K Hinson, MD, PhD Medical University of South Carolina
  More Information

Responsible Party: Vanessa Hinson, Director, Movement Disorders Program, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01738191     History of Changes
Other Study ID Numbers: ATM-Cog 
Study First Received: November 28, 2012
Last Updated: March 14, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Medical University of South Carolina:
Parkinson's disease

Additional relevant MeSH terms:
Parkinson Disease
Cognition Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Atomoxetine Hydrochloride
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 09, 2016