Trial Outcomes & Findings for Cog-VACCINE: Cognitive Training in Patients With Vascular Cognitive Impairment, no Dementia (NCT NCT02640716)
NCT ID: NCT02640716
Last Updated: 2020-07-23
Results Overview
The study uses MoCA to assess changes in the global cognitive function after an intervention of cognitive training. Baseline and 7-week were the two relevant time points used in the calculation. The score of MoCA ranges from 0 to 30, and higher scores mean a better outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
Baseline and 7 weeks
Results posted on
2020-07-23
Participant Flow
Participant milestones
| Measure |
Training Group
Intervention: Multi-domain adaptive internet-based training program, including processing speed, attention, long-term memory, working memory, flexibility, calculation, and problem solving. 5 x 30 minutes per week, for 7 weeks.
multi-domain internet-based adaptive training program: The cognitive training will be a multi-domain adaptive training program, including processing speed, attention, long-term memory, working memory, flexibility, calculation, and problem solving. Specific training paradigms include a time perception task, visual search task, attention blink, delayed mapping task, attention span task, Go-No go task, Stroop task, task switching, and name-face match task, among others. To maintain task difficulty, the tasks will be grouped based on the task difficulty in each domain. Furthermore, each task will have various difficulty levels.
|
Control Group
Intervention: placebo program: a fixed, primary difficulty level task. 5 x 30 minutes per week, for 7 weeks.
placebo program: For the control group, tasks for processing speed and attention are included. Importantly, a fixed, primary difficulty level for all participants in the control group is set.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
Training Completion
|
27
|
27
|
|
Overall Study
COMPLETED
|
23
|
21
|
|
Overall Study
NOT COMPLETED
|
7
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Training Group
n=30 Participants
Intervention: Multi-domain adaptive internet-based training program, including processing speed, attention, long-term memory, working memory, flexibility, calculation, and problem solving. 5 x 30 minutes per week, for 7 weeks.
multi-domain internet-based adaptive training program: The cognitive training will be a multi-domain adaptive training program, including processing speed, attention, long-term memory, working memory, flexibility, calculation, and problem solving. Specific training paradigms include a time perception task, visual search task, attention blink, delayed mapping task, attention span task, Go-No go task, Stroop task, task switching, and name-face match task, among others. To maintain task difficulty, the tasks will be grouped based on the task difficulty in each domain. Furthermore, each task will have various difficulty levels.
|
Control Group
n=30 Participants
Intervention: placebo program: a fixed, primary difficulty level task. 5 x 30 minutes per week, for 7 weeks.
placebo program: For the control group, tasks for processing speed and attention are included. Importantly, a fixed, primary difficulty level for all participants in the control group is set.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.9 years
STANDARD_DEVIATION 7.9 • n=30 Participants
|
64.9 years
STANDARD_DEVIATION 6.6 • n=30 Participants
|
64.4 years
STANDARD_DEVIATION 6.5 • n=60 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=30 Participants
|
8 Participants
n=30 Participants
|
20 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=30 Participants
|
22 Participants
n=30 Participants
|
40 Participants
n=60 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
China
|
30 participants
n=30 Participants
|
30 participants
n=30 Participants
|
60 participants
n=60 Participants
|
|
Montreal Cognitive Assessment (MoCA)
|
21.9 units on a scale
STANDARD_DEVIATION 3.8 • n=30 Participants
|
21.2 units on a scale
STANDARD_DEVIATION 3.8 • n=30 Participants
|
21.5 units on a scale
STANDARD_DEVIATION 3.8 • n=60 Participants
|
|
Trail Making Test B-A (TMT B-A)
|
74.0 second
STANDARD_DEVIATION 56.6 • n=30 Participants
|
77.0 second
STANDARD_DEVIATION 65.3 • n=30 Participants
|
75.5 second
STANDARD_DEVIATION 60.5 • n=60 Participants
|
PRIMARY outcome
Timeframe: Baseline and 7 weeksThe study uses MoCA to assess changes in the global cognitive function after an intervention of cognitive training. Baseline and 7-week were the two relevant time points used in the calculation. The score of MoCA ranges from 0 to 30, and higher scores mean a better outcome.
Outcome measures
| Measure |
Training Group
n=30 Participants
Intervention: Multi-domain adaptive internet-based training program, including processing speed, attention, long-term memory, working memory, flexibility, calculation, and problem solving. 5 x 30 minutes per week, for 7 weeks.
multi-domain internet-based adaptive training program: The cognitive training will be a multi-domain adaptive training program, including processing speed, attention, long-term memory, working memory, flexibility, calculation, and problem solving. Specific training paradigms include a time perception task, visual search task, attention blink, delayed mapping task, attention span task, Go-No go task, Stroop task, task switching, and name-face match task, among others. To maintain task difficulty, the tasks will be grouped based on the task difficulty in each domain. Furthermore, each task will have various difficulty levels.
|
Control Group
n=30 Participants
Intervention: placebo program: a fixed, primary difficulty level task. 5 x 30 minutes per week, for 7 weeks.
placebo program: For the control group, tasks for processing speed and attention are included. Importantly, a fixed, primary difficulty level for all participants in the control group is set.
|
|---|---|---|
|
Estimated Mean Change of the Montreal Cognitive Assessment (MoCA)
|
3.356 score on a scale
Interval 1.467 to 5.244
|
-0.085 score on a scale
Interval -2.062 to 1.892
|
PRIMARY outcome
Timeframe: Baseline and 7 weeksThe Trail Making Test is a commonly used neuropsychological test of visual attention and task-switching. In two timed tasks, subjects are asked to first connect numbers (Test A), then alternating numbers and letters (Test B), in sequential order as quickly as possible. Completion times, relating to cognitive processing speed and executive function (respectively) are represented as a difference (B-A). The Trail Making Test is a commonly used neuropsychological test of visual attention and task-switching. In two timed tasks, subjects are asked to first connect numbers (Test A), then alternating numbers and letters (Test B), in sequential order as quickly as possible. Completion times, relating to cognitive processing speed and executive function (respectively) are represented as a difference (B-A). The change from baseline at week 7 in the B-A difference is reported as a primar
Outcome measures
| Measure |
Training Group
n=30 Participants
Intervention: Multi-domain adaptive internet-based training program, including processing speed, attention, long-term memory, working memory, flexibility, calculation, and problem solving. 5 x 30 minutes per week, for 7 weeks.
multi-domain internet-based adaptive training program: The cognitive training will be a multi-domain adaptive training program, including processing speed, attention, long-term memory, working memory, flexibility, calculation, and problem solving. Specific training paradigms include a time perception task, visual search task, attention blink, delayed mapping task, attention span task, Go-No go task, Stroop task, task switching, and name-face match task, among others. To maintain task difficulty, the tasks will be grouped based on the task difficulty in each domain. Furthermore, each task will have various difficulty levels.
|
Control Group
n=30 Participants
Intervention: placebo program: a fixed, primary difficulty level task. 5 x 30 minutes per week, for 7 weeks.
placebo program: For the control group, tasks for processing speed and attention are included. Importantly, a fixed, primary difficulty level for all participants in the control group is set.
|
|---|---|---|
|
Estimated Mean Change of the Trail Making Test (TMT) B-A
|
-5.958 second
Interval -38.558 to 26.642
|
-10.702 second
Interval -45.259 to 23.856
|
SECONDARY outcome
Timeframe: Baseline and 7 weeksThe left hippocampal volume on structural Magnetic Resonance Imaging (MRI) was measured by voxel-based morphometrics. The estimated mean changes in left hippocampal volume from baseline at week 7 is reported.
Outcome measures
| Measure |
Training Group
n=30 Participants
Intervention: Multi-domain adaptive internet-based training program, including processing speed, attention, long-term memory, working memory, flexibility, calculation, and problem solving. 5 x 30 minutes per week, for 7 weeks.
multi-domain internet-based adaptive training program: The cognitive training will be a multi-domain adaptive training program, including processing speed, attention, long-term memory, working memory, flexibility, calculation, and problem solving. Specific training paradigms include a time perception task, visual search task, attention blink, delayed mapping task, attention span task, Go-No go task, Stroop task, task switching, and name-face match task, among others. To maintain task difficulty, the tasks will be grouped based on the task difficulty in each domain. Furthermore, each task will have various difficulty levels.
|
Control Group
n=30 Participants
Intervention: placebo program: a fixed, primary difficulty level task. 5 x 30 minutes per week, for 7 weeks.
placebo program: For the control group, tasks for processing speed and attention are included. Importantly, a fixed, primary difficulty level for all participants in the control group is set.
|
|---|---|---|
|
Estimated Mean Changes in Left Hippocampal Volume
|
-105.673 Cubic millimeter
Interval -287.585 to 76.239
|
-70.266 Cubic millimeter
Interval -269.43 to 128.899
|
SECONDARY outcome
Timeframe: Baseline and 7 weeksThe right hippocampal volume on structural Magnetic Resonance Imaging (MRI) was measured by voxel-based morphometrics. The estimated mean change in right hippocampal volume from baseline at week 7 is reported.
Outcome measures
| Measure |
Training Group
n=30 Participants
Intervention: Multi-domain adaptive internet-based training program, including processing speed, attention, long-term memory, working memory, flexibility, calculation, and problem solving. 5 x 30 minutes per week, for 7 weeks.
multi-domain internet-based adaptive training program: The cognitive training will be a multi-domain adaptive training program, including processing speed, attention, long-term memory, working memory, flexibility, calculation, and problem solving. Specific training paradigms include a time perception task, visual search task, attention blink, delayed mapping task, attention span task, Go-No go task, Stroop task, task switching, and name-face match task, among others. To maintain task difficulty, the tasks will be grouped based on the task difficulty in each domain. Furthermore, each task will have various difficulty levels.
|
Control Group
n=30 Participants
Intervention: placebo program: a fixed, primary difficulty level task. 5 x 30 minutes per week, for 7 weeks.
placebo program: For the control group, tasks for processing speed and attention are included. Importantly, a fixed, primary difficulty level for all participants in the control group is set.
|
|---|---|---|
|
Estimated Mean Change in Right Hippocampal Volume
|
-0.276 Cubic millimeter
Interval -185.672 to 185.119
|
-103.716 Cubic millimeter
Interval -316.408 to 108.975
|
SECONDARY outcome
Timeframe: Baseline and 7 weeksThe white matter microstructure was measured by diffusion tensor imaging (DTI) . The whole-brain average fractional anisotropy (FA) was calculated to show brain white matter integrity. The change of whole-brain average FA from baseline at week 7 is reported. Fractional anisotropy (FA) is a scalar value between zero and one that describes the degree of anisotropy of a diffusion process. A value of zero means that diffusion is isotropic, i.e. it is unrestricted (or equally restricted) in all directions.
Outcome measures
| Measure |
Training Group
n=30 Participants
Intervention: Multi-domain adaptive internet-based training program, including processing speed, attention, long-term memory, working memory, flexibility, calculation, and problem solving. 5 x 30 minutes per week, for 7 weeks.
multi-domain internet-based adaptive training program: The cognitive training will be a multi-domain adaptive training program, including processing speed, attention, long-term memory, working memory, flexibility, calculation, and problem solving. Specific training paradigms include a time perception task, visual search task, attention blink, delayed mapping task, attention span task, Go-No go task, Stroop task, task switching, and name-face match task, among others. To maintain task difficulty, the tasks will be grouped based on the task difficulty in each domain. Furthermore, each task will have various difficulty levels.
|
Control Group
n=30 Participants
Intervention: placebo program: a fixed, primary difficulty level task. 5 x 30 minutes per week, for 7 weeks.
placebo program: For the control group, tasks for processing speed and attention are included. Importantly, a fixed, primary difficulty level for all participants in the control group is set.
|
|---|---|---|
|
Estimated Mean Change in Brain White Matter Integrity
|
-0.008 units on a scale
Interval -0.031 to 0.014
|
0.004 units on a scale
Interval -0.015 to 0.023
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 6 monthsThe participants will be followed up 6 months after recruitment. The training is not mandatory after 7 weeks, but the training details will be acquired from the online system. The change from baseline at month 6 in the MoCA difference is reported. The score of Moca ranges from 0 to 30, and higher scores mean a better outcome.
Outcome measures
| Measure |
Training Group
n=30 Participants
Intervention: Multi-domain adaptive internet-based training program, including processing speed, attention, long-term memory, working memory, flexibility, calculation, and problem solving. 5 x 30 minutes per week, for 7 weeks.
multi-domain internet-based adaptive training program: The cognitive training will be a multi-domain adaptive training program, including processing speed, attention, long-term memory, working memory, flexibility, calculation, and problem solving. Specific training paradigms include a time perception task, visual search task, attention blink, delayed mapping task, attention span task, Go-No go task, Stroop task, task switching, and name-face match task, among others. To maintain task difficulty, the tasks will be grouped based on the task difficulty in each domain. Furthermore, each task will have various difficulty levels.
|
Control Group
n=30 Participants
Intervention: placebo program: a fixed, primary difficulty level task. 5 x 30 minutes per week, for 7 weeks.
placebo program: For the control group, tasks for processing speed and attention are included. Importantly, a fixed, primary difficulty level for all participants in the control group is set.
|
|---|---|---|
|
Estimated Mean Change of MoCA
|
2.224 score on a scale
Interval 0.256 to 4.192
|
1.358 score on a scale
Interval -0.899 to 3.614
|
Adverse Events
Training Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Yi Tang
Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China
Phone: +86 10 83199456
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place