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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Medical University of South Carolina
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: November 29, 2012
Last verified: November 2012

November 28, 2012
November 29, 2012
November 2012
May 2015   (final data collection date for primary outcome measure)
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 ATM for the treatment of attention, set-shifting, information processing speed and working memory deficits in cognitively impaired, non-demented patients with 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.
Same as current
Complete list of historical versions of study NCT01738191 on ClinicalTrials.gov Archive Site
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 symptom scale (NMSS), comprehensive metabolic panel, and ECG.
Same as current
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 (Parkinson's Disease Questionnaire (PDQ-39), and Mood disturbance (Geriatric Depression Scale (GDS), Geriatric Anxiety Scale (GAI).

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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Parkinson's Disease
  • Cognitive Impairment
  • 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
  • Drug: Placebo
  • Active Comparator: 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.
    Intervention: Drug: Atomoxetine
  • Placebo Comparator: Placebo
    Patients in the placebo arm will follow the same titration schedule as those in teh 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.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
May 2015
May 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Confirmed diagnosis of idiopathic PD according to the UK PD 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 MCI, Montreal Cognitive Assessment (MoCa) score 21-25
  • Stable concomitant medications for 60 days

Exclusion Criteria:

  • Secondary parkinsonism or atypical parkinsonism, Prior DBS or other brain surgery
  • PD Dementia; MoCA score <21
  • Presence of Psychosis, pregnancy, suicidal ideation on the C-SSRS type 4 or 5 in past 3 months.
  • Current treatment with anticholinergics, MAO inhibitors or neuroleptics (including quetiapine)
  • Serious cardiac abnormalities, Narrow angle glaucoma, Pheochromocytoma, Bipolar Disorder
  • LFTs>1.5 X upper limit of normal value
Both
35 Years to 75 Years
No
Contact: Jennifer Zimmerman, RN, BSN 843-792-9115 zimmerj@musc.edu
United States
 
NCT01738191
ATM-Cog
Yes
Vanessa Hinson, Medical University of South Carolina
Medical University of South Carolina
Michael J. Fox Foundation for Parkinson's Research
Principal Investigator: Vanessa Hinson, MD, PhD Medical University of South Carolina
Medical University of South Carolina
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP