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

Primary Purpose

Parkinson's Disease, Cognitive Impairment

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Atomoxetine
Placebo
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Atomoxetine

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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 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 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 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 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 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 in WAIS-IV: Digit Span
Wechsler Adult Intelligence Scale, fourth edition Digit Span | Scaled | age| 1-16 Higher scores mean a better outcome.

Full Information

First Posted
November 28, 2012
Last Updated
July 25, 2018
Sponsor
Medical University of South Carolina
Collaborators
Michael J. Fox Foundation for Parkinson's Research
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1. Study Identification

Unique Protocol Identification Number
NCT01738191
Brief Title
Atomoxetine Treatment for Cognitive Impairment in Parkinson's Disease (ATM-Cog)
Acronym
ATM-Cog
Official Title
Atomoxetine Treatment for Cognitive Impairment in Parkinson's Disease (ATM-Cog)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
Michael J. Fox Foundation for Parkinson's Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, Cognitive Impairment
Keywords
Parkinson's disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Atomoxetine
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Atomoxetine
Other Intervention Name(s)
Strattera
Intervention Description
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 Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
The Global Statistical Test Combined Information on Change From Baseline on a Battery of Standardized Executive Function Tests
Description
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).
Time Frame
change from baseline and 10 weeks
Secondary Outcome Measure Information:
Title
Change in PASAT
Description
Paced Auditory Serial Addition Test 3-second interstimulus interval | Z-score| age & education normed| range -5 to +5 Higher scores mean a better outcome.
Time Frame
change from baseline and 10 weeks
Title
Change in NAB: Part A
Description
Neuropsychological Assessment Battery Numbers & Letters A Efficiency | T-score| age & education normed| range 19-70 Higher scores mean a better outcome.
Time Frame
change from baseline and 10 weeks
Title
Change in NAB: Part D
Description
Neuropsychological Assessment Battery Numbers & Letters D Efficiency | T-score| age & education normed| range 19-70 Higher scores mean a better outcome.
Time Frame
change from baseline and 10 weeks
Title
Change in D-KEFS: Inhibition Time
Description
Delis-Kaplan Executive Function System Color-Word Inhibition Time | Scaled | age normed| range 1-16 Higher scores mean a better outcome.
Time Frame
change from baseline and 10 weeks
Title
Change in D-KEFS: Inhibition-Switching Time
Description
Delis-Kaplan Executive Function System Color-Word Inhibition/Switching | Scaled | age normed| range 1-16 Higher scores mean a better outcome.
Time Frame
change from baseline and 10 weeks
Title
Change in D-KEFS: Number-Letter Switching Time
Description
Delis-Kaplan Executive Function System Trail Making Number/Letter Switching | Scaled | age normed| range 1-16 Higher scores mean a better outcome.
Time Frame
change from baseline and 10 weeks
Title
Change in WAIS-IV: Digit Span
Description
Wechsler Adult Intelligence Scale, fourth edition Digit Span | Scaled | age| 1-16 Higher scores mean a better outcome.
Time Frame
change from baseline and 10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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 <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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vanessa K Hinson, MD, PhD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

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

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