Trial Outcomes & Findings for Atomoxetine Treatment for Cognitive Impairment in Parkinson's Disease (ATM-Cog) (NCT NCT01738191)
NCT ID: NCT01738191
Last Updated: 2018-08-23
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
change from baseline and 10 weeks
Results posted on
2018-08-23
Participant Flow
Participant milestones
| Measure |
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.
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
11
|
14
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
1
|
Baseline Characteristics
Atomoxetine Treatment for Cognitive Impairment in Parkinson's Disease (ATM-Cog)
Baseline characteristics by cohort
| Measure |
Atomoxetine
n=15 Participants
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.
|
Placebo
n=15 Participants
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
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.9 years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
66.7 years
STANDARD_DEVIATION 7.7 • n=7 Participants
|
66.8 years
STANDARD_DEVIATION 7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: change from baseline and 10 weeksPopulation: Intent-to-treat sample of all patients randomized.
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).
Outcome measures
| Measure |
Atomoxetine
n=15 Participants
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.
|
Placebo
n=15 Participants
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
|
|---|---|---|
|
The Global Statistical Test Combined Information on Change From Baseline on a Battery of Standardized Executive Function Tests
|
99.5 summed-ranks
Interval 73.1 to 126.0
|
117.5 summed-ranks
Interval 98.5 to 136.4
|
SECONDARY outcome
Timeframe: change from baseline and 10 weeksPopulation: Intent-to-treat sample of all patients randomized.
Paced Auditory Serial Addition Test 3-second interstimulus interval \| Z-score\| age \& education normed\| range -5 to +5 Higher scores mean a better outcome.
Outcome measures
| Measure |
Atomoxetine
n=15 Participants
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.
|
Placebo
n=15 Participants
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
|
|---|---|---|
|
Change in PASAT
|
-0.96 units on a scale
Standard Deviation 1.96
|
0.42 units on a scale
Standard Deviation 1.22
|
SECONDARY outcome
Timeframe: change from baseline and 10 weeksPopulation: Intent-to-treat sample of all patients randomized.
Neuropsychological Assessment Battery Numbers \& Letters A Efficiency \| T-score\| age \& education normed\| range 19-70 Higher scores mean a better outcome.
Outcome measures
| Measure |
Atomoxetine
n=15 Participants
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.
|
Placebo
n=15 Participants
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
|
|---|---|---|
|
Change in NAB: Part A
|
-0.71 units on a scale
Standard Deviation 1.05
|
-0.23 units on a scale
Standard Deviation 1.07
|
SECONDARY outcome
Timeframe: change from baseline and 10 weeksPopulation: Intent-to-treat sample of all patients randomized.
Neuropsychological Assessment Battery Numbers \& Letters D Efficiency \| T-score\| age \& education normed\| range 19-70 Higher scores mean a better outcome.
Outcome measures
| Measure |
Atomoxetine
n=15 Participants
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.
|
Placebo
n=15 Participants
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
|
|---|---|---|
|
Change in NAB: Part D
|
-0.35 units on a scale
Standard Deviation 1.31
|
-0.11 units on a scale
Standard Deviation 0.75
|
SECONDARY outcome
Timeframe: change from baseline and 10 weeksPopulation: Intent-to-treat sample of all patients randomized.
Delis-Kaplan Executive Function System Color-Word Inhibition Time \| Scaled \| age normed\| range 1-16 Higher scores mean a better outcome.
Outcome measures
| Measure |
Atomoxetine
n=15 Participants
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.
|
Placebo
n=15 Participants
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
|
|---|---|---|
|
Change in D-KEFS: Inhibition Time
|
-0.77 units on a scale
Standard Deviation 1.4
|
-0.3 units on a scale
Standard Deviation 1.17
|
SECONDARY outcome
Timeframe: change from baseline and 10 weeksPopulation: Intent-to-treat sample of all patients randomized.
Delis-Kaplan Executive Function System Color-Word Inhibition/Switching \| Scaled \| age normed\| range 1-16 Higher scores mean a better outcome.
Outcome measures
| Measure |
Atomoxetine
n=15 Participants
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.
|
Placebo
n=15 Participants
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
|
|---|---|---|
|
Change in D-KEFS: Inhibition-Switching Time
|
-0.87 units on a scale
Standard Deviation 1.63
|
-0.2 units on a scale
Standard Deviation 1.63
|
SECONDARY outcome
Timeframe: change from baseline and 10 weeksPopulation: Intent-to-treat sample of all patients randomized.
Delis-Kaplan Executive Function System Trail Making Number/Letter Switching \| Scaled \| age normed\| range 1-16 Higher scores mean a better outcome.
Outcome measures
| Measure |
Atomoxetine
n=15 Participants
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.
|
Placebo
n=15 Participants
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
|
|---|---|---|
|
Change in D-KEFS: Number-Letter Switching Time
|
-0.9 units on a scale
Standard Deviation 1.33
|
-0.67 units on a scale
Standard Deviation 1.43
|
SECONDARY outcome
Timeframe: change from baseline and 10 weeksPopulation: Intent-to-treat sample of all patients randomized.
Wechsler Adult Intelligence Scale, fourth edition Digit Span \| Scaled \| age\| 1-16 Higher scores mean a better outcome.
Outcome measures
| Measure |
Atomoxetine
n=15 Participants
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.
|
Placebo
n=15 Participants
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
|
|---|---|---|
|
Change in WAIS-IV: Digit Span
|
-0.17 units on a scale
Standard Deviation 0.8
|
0 units on a scale
Standard Deviation 0.67
|
Adverse Events
Atomoxetine
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Atomoxetine
n=15 participants at risk
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.
|
Placebo
n=15 participants at risk
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
|
|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
6.7%
1/15 • Number of events 1
|
6.7%
1/15 • Number of events 1
|
|
Nervous system disorders
Jitters
|
20.0%
3/15 • Number of events 3
|
6.7%
1/15 • Number of events 3
|
|
Cardiac disorders
Syncopal Episode
|
6.7%
1/15 • Number of events 2
|
0.00%
0/15
|
|
Gastrointestinal disorders
Nausea
|
6.7%
1/15 • Number of events 1
|
0.00%
0/15
|
|
Cardiac disorders
Chest pain
|
6.7%
1/15 • Number of events 1
|
0.00%
0/15
|
|
Nervous system disorders
Decreased memory
|
0.00%
0/15
|
6.7%
1/15 • Number of events 3
|
|
Cardiac disorders
Hypertension
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
Additional Information
Dr. Vanessa Hinson
Medical University of South Carolina
Phone: 843-792-9115
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place