Trial Outcomes & Findings for Remediation of Age-related Cognitive Decline: Vortioxetine and Cognitive Training (NCT NCT03272711)
NCT ID: NCT03272711
Last Updated: 2020-01-14
Results Overview
Total fluid cognitive score from the NIH Toolbox as well as the speed of cognitive improvement The study utilized five cognitive tests from the NIH Toolbox Cognitive Battery that measured "fluid" cognition-the capacity for new learning and information processing. A higher score indicates indicates better performance on these tests. A total fluid cognitive score at or near 100 indicates ability that is average compared with others nationally. Scores around 115 suggest above-average fluid cognitive ability, while scores around 130 suggest superior ability. Conversely, a score around 85 suggests below-average fluid cognitive ability, and a score in the range of 70 or below suggests significant impairment.
COMPLETED
PHASE4
129 participants
Randomization (0 weeks), 4 weeks
2020-01-14
Participant Flow
Twenty-nine participants were not assigned to a group. Twenty did not meet eligibility criteria for randomization, 8 individuals declined to participate further and one person was a pilot participant.
Participant milestones
| Measure |
Vortioxetine Plus Cognitive Training
Vortioxetine (10 mg) plus cognitive training 5 times weekly for 30 minutes a day
Vortioxetine 10 mg
Cognitive training program: Online training program, 30 minutes a day, 5 times a week
|
Placebo Plus Cognitive Training
Placebo plus cognitive training 5 times weekly for 30 minutes a day
Cognitive training program: Online training program, 30 minutes a day, 5 times a week
|
|---|---|---|
|
Overall Study
STARTED
|
51
|
49
|
|
Overall Study
COMPLETED
|
44
|
41
|
|
Overall Study
NOT COMPLETED
|
7
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Remediation of Age-related Cognitive Decline: Vortioxetine and Cognitive Training
Baseline characteristics by cohort
| Measure |
Vortioxetine Plus Cognitive Training
n=51 Participants
Vortioxetine (10 mg) plus cognitive training 5 times weekly for 30 minutes a day
Vortioxetine 10 mg
Cognitive training program: Online training program, 30 minutes a day, 5 times a week
|
Placebo Plus Cognitive Training
n=49 Participants
Placebo plus cognitive training 5 times weekly for 30 minutes a day
Cognitive training program: Online training program, 30 minutes a day, 5 times a week
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.68 years
STANDARD_DEVIATION 4.77 • n=5 Participants
|
71.88 years
STANDARD_DEVIATION 5.3 • n=7 Participants
|
71.78 years
STANDARD_DEVIATION 5.01 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
50 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 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
|
51 participants
n=5 Participants
|
49 participants
n=7 Participants
|
100 participants
n=5 Participants
|
|
Years of Schooling
|
16.80 years
STANDARD_DEVIATION 2.48 • n=5 Participants
|
16.63 years
STANDARD_DEVIATION 3.24 • n=7 Participants
|
16.72 years
STANDARD_DEVIATION 2.87 • n=5 Participants
|
PRIMARY outcome
Timeframe: Randomization (0 weeks), 4 weeksTotal fluid cognitive score from the NIH Toolbox as well as the speed of cognitive improvement The study utilized five cognitive tests from the NIH Toolbox Cognitive Battery that measured "fluid" cognition-the capacity for new learning and information processing. A higher score indicates indicates better performance on these tests. A total fluid cognitive score at or near 100 indicates ability that is average compared with others nationally. Scores around 115 suggest above-average fluid cognitive ability, while scores around 130 suggest superior ability. Conversely, a score around 85 suggests below-average fluid cognitive ability, and a score in the range of 70 or below suggests significant impairment.
Outcome measures
| Measure |
Vortioxetine Plus Cognitive Training
n=51 Participants
Vortioxetine (10 mg) plus cognitive training 5 times weekly for 30 minutes a day
Vortioxetine 10 mg
Cognitive training program: Online training program, 30 minutes a day, 5 times a week
|
Placebo Plus Cognitive Training
n=49 Participants
Placebo plus cognitive training 5 times weekly for 30 minutes a day
Cognitive training program: Online training program, 30 minutes a day, 5 times a week
|
|---|---|---|
|
Change in Total Fluid Cognitive Score
Change in Total Fluid Cognitive Score
|
6.14 score on a scale
Standard Deviation 7.80
|
3.71 score on a scale
Standard Deviation 7.27
|
|
Change in Total Fluid Cognitive Score
Week 4 Total Fluid Cogntive Score
|
106.06 score on a scale
Standard Deviation 17.06
|
105.85 score on a scale
Standard Deviation 12.38
|
SECONDARY outcome
Timeframe: Randomization (0 weeks), 4 week, 12 week, 26 weekTotal fluid cognitive score from the NIH Toolbox as well as the speed of cognitive improvement The study utilized five cognitive tests from the NIH Toolbox Cognitive Battery that measured "fluid" cognition-the capacity for new learning and information processing. A higher score indicates indicates better performance on these tests. A total fluid cognitive score at or near 100 indicates ability that is average compared with others nationally. Scores around 115 suggest above-average fluid cognitive ability, while scores around 130 suggest superior ability. Conversely, a score around 85 suggests below-average fluid cognitive ability, and a score in the range of 70 or below suggests significant impairment.
Outcome measures
| Measure |
Vortioxetine Plus Cognitive Training
n=51 Participants
Vortioxetine (10 mg) plus cognitive training 5 times weekly for 30 minutes a day
Vortioxetine 10 mg
Cognitive training program: Online training program, 30 minutes a day, 5 times a week
|
Placebo Plus Cognitive Training
n=49 Participants
Placebo plus cognitive training 5 times weekly for 30 minutes a day
Cognitive training program: Online training program, 30 minutes a day, 5 times a week
|
|---|---|---|
|
Change in Total Fluid Cognitive Score
Change at Week 4
|
6.14 score on a scale
Standard Deviation 7.8
|
3.71 score on a scale
Standard Deviation 7.27
|
|
Change in Total Fluid Cognitive Score
Change at Week 12
|
8.24 score on a scale
Standard Deviation 7.82
|
3.93 score on a scale
Standard Deviation 6.70
|
|
Change in Total Fluid Cognitive Score
Change at Week 26
|
7.55 score on a scale
Standard Deviation 7.95
|
6.05 score on a scale
Standard Deviation 8.26
|
|
Change in Total Fluid Cognitive Score
Total Fluid Cognitive Score at Week 4
|
106.06 score on a scale
Standard Deviation 17.06
|
105.85 score on a scale
Standard Deviation 12.38
|
|
Change in Total Fluid Cognitive Score
Total Fluid Cognitive Score at Week 12
|
108.12 score on a scale
Standard Deviation 16.34
|
105.57 score on a scale
Standard Deviation 12.31
|
|
Change in Total Fluid Cognitive Score
Total Fluid Cognitive Score at Week 26
|
106.98 score on a scale
Standard Deviation 17.19
|
107.51 score on a scale
Standard Deviation 11.44
|
SECONDARY outcome
Timeframe: Randomization (0 weeks), 26 weeksParticipant function assessed using the UCSD Performance-Based Skills Assessment (UPSA). A validated test that required participants to demonstrate their competence to perform everyday functioning tasks in domains such as comprehension, planning, finances, transportation and communication. A higher scores indicates a better outcome. Scores can range from a minimum of 0 to a maximum of 100.
Outcome measures
| Measure |
Vortioxetine Plus Cognitive Training
n=51 Participants
Vortioxetine (10 mg) plus cognitive training 5 times weekly for 30 minutes a day
Vortioxetine 10 mg
Cognitive training program: Online training program, 30 minutes a day, 5 times a week
|
Placebo Plus Cognitive Training
n=49 Participants
Placebo plus cognitive training 5 times weekly for 30 minutes a day
Cognitive training program: Online training program, 30 minutes a day, 5 times a week
|
|---|---|---|
|
Participant Function
Change in UPSA Score
|
2.91 score on a scale
Standard Deviation 7.26
|
1.66 score on a scale
Standard Deviation 8.73
|
|
Participant Function
Total UPSA Score at Week 26
|
84.50 score on a scale
Standard Deviation 8.80
|
82.44 score on a scale
Standard Deviation 8.59
|
Adverse Events
Vortioxetine Plus Cognitive Training
Placebo Plus Cognitive Training
Serious adverse events
| Measure |
Vortioxetine Plus Cognitive Training
n=51 participants at risk
Vortioxetine (10 mg) plus cognitive training 5 times weekly for 30 minutes a day
Vortioxetine 10 mg
Cognitive training program: Online training program, 30 minutes a day, 5 times a week
|
Placebo Plus Cognitive Training
n=49 participants at risk
Placebo plus cognitive training 5 times weekly for 30 minutes a day
Cognitive training program: Online training program, 30 minutes a day, 5 times a week
|
|---|---|---|
|
Cardiac disorders
Worsening of Coronary Artery Disease
|
0.00%
0/51 • 26 weeks
|
2.0%
1/49 • Number of events 1 • 26 weeks
|
|
Infections and infestations
Hospitalization for Bacterial Infection
|
0.00%
0/51 • 26 weeks
|
2.0%
1/49 • Number of events 1 • 26 weeks
|
Other adverse events
| Measure |
Vortioxetine Plus Cognitive Training
n=51 participants at risk
Vortioxetine (10 mg) plus cognitive training 5 times weekly for 30 minutes a day
Vortioxetine 10 mg
Cognitive training program: Online training program, 30 minutes a day, 5 times a week
|
Placebo Plus Cognitive Training
n=49 participants at risk
Placebo plus cognitive training 5 times weekly for 30 minutes a day
Cognitive training program: Online training program, 30 minutes a day, 5 times a week
|
|---|---|---|
|
Gastrointestinal disorders
nausea
|
29.4%
15/51 • 26 weeks
|
4.1%
2/49 • 26 weeks
|
|
General disorders
viral illness
|
17.6%
9/51 • 26 weeks
|
16.3%
8/49 • 26 weeks
|
|
Skin and subcutaneous tissue disorders
Rashes or pruritis
|
9.8%
5/51 • 26 weeks
|
6.1%
3/49 • 26 weeks
|
|
Gastrointestinal disorders
Constipation
|
7.8%
4/51 • 26 weeks
|
2.0%
1/49 • 26 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
5.9%
3/51 • 26 weeks
|
6.1%
3/49 • 26 weeks
|
|
General disorders
Dizziness
|
5.9%
3/51 • 26 weeks
|
0.00%
0/49 • 26 weeks
|
|
General disorders
Musculoskeletal aches
|
5.9%
3/51 • 26 weeks
|
6.1%
3/49 • 26 weeks
|
|
General disorders
Dental infectkons/aches
|
5.9%
3/51 • 26 weeks
|
2.0%
1/49 • 26 weeks
|
|
Gastrointestinal disorders
Vomiting
|
3.9%
2/51 • 26 weeks
|
0.00%
0/49 • 26 weeks
|
Additional Information
Dr. Eric Lenze
Washington University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place