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| Name | Class |
|---|---|
| Michael J. Fox Foundation for Parkinson's Research | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in NAB: Part A |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vanessa K Hinson, MD, PhD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | 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. Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Intent-to-treat sample of all patients randomized. | Posted | Mean | 95% Confidence Interval | summed-ranks | change from baseline and 10 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Vanessa Hinson | Medical University of South Carolina | 843-792-9115 | hinsonvk@musc.edu |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000069445 | Atomoxetine Hydrochloride |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Placebo | Drug |
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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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| BG001 | 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. Placebo |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | 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. Placebo |
|
|
|
| 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. | Intent-to-treat sample of all patients randomized. | Posted | Mean | Standard Deviation | units on a scale | 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. | Intent-to-treat sample of all patients randomized. | Posted | Mean | Standard Deviation | units on a scale | 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. | Intent-to-treat sample of all patients randomized. | Posted | Mean | Standard Deviation | units on a scale | 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. | Intent-to-treat sample of all patients randomized. | Posted | Mean | Standard Deviation | units on a scale | 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. | Intent-to-treat sample of all patients randomized. | Posted | Mean | Standard Deviation | units on a scale | 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. | Intent-to-treat sample of all patients randomized. | Posted | Mean | Standard Deviation | units on a scale | change from baseline and 10 weeks |
|
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| 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. | Intent-to-treat sample of all patients randomized. | Posted | Mean | Standard Deviation | units on a scale | change from baseline and 10 weeks |
|
|
|
| 0 |
| 15 |
| 4 |
| 15 |
| EG001 | 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. Placebo | 0 | 15 | 1 | 15 |
| Jitters | Nervous system disorders |
|
| Syncopal Episode | Cardiac disorders |
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| Nausea | Gastrointestinal disorders |
|
| Chest pain | Cardiac disorders | Systematic Assessment |
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| Decreased memory | Nervous system disorders | Systematic Assessment |
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| Hypertension | Cardiac disorders | Systematic Assessment |
|
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |