Trial Outcomes & Findings for Cognitive Training and Practice Effects in Mild Cognitive Impairment (NCT NCT02301546)
NCT ID: NCT02301546
Last Updated: 2020-06-09
Results Overview
This is a composite of six subtests of the Repeatable Battery for the Assessment of Neuropsychological Status. It is a standard score (mean=100, standard deviation=15), with a range of approximately 45 - 145, with higher scores indicating better outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
197 participants
Primary outcome timeframe
13 weeks
Results posted on
2020-06-09
Participant Flow
51 individuals were enrolled in the study but were withdrawn by the research team because they did not meet criteria for amnestic Mild Cognitive Impairment on objective testing.
Participant milestones
| Measure |
Experimental Cognitive Training
Participants will use experimental computerized cognitive training exercises, 1 hour per day, 3 - 5 days per week, for 13 weeks.
computerized cognitive exercises: Each group will perform computerized cognitive exercises, 1 hour per day, 3 - 5 days per week, for 13 weeks. The experimental group will use exercises shown to improve cognition, whereas the comparator group will use exercises without clear beneficial findings.
|
Control Cognitive Exercises
Participants will use control computerized cognitive activities, 1 hour per day, 3 - 5 days per week, for 13 weeks.
computerized cognitive exercises: Each group will perform computerized cognitive exercises, 1 hour per day, 3 - 5 days per week, for 13 weeks. The experimental group will use exercises shown to improve cognition, whereas the comparator group will use exercises without clear beneficial findings.
|
|---|---|---|
|
Short-term Effectiveness (~13 Weeks)
STARTED
|
73
|
73
|
|
Short-term Effectiveness (~13 Weeks)
COMPLETED
|
55
|
58
|
|
Short-term Effectiveness (~13 Weeks)
NOT COMPLETED
|
18
|
15
|
|
Long Term Effectiveness (~1 Year)
STARTED
|
55
|
58
|
|
Long Term Effectiveness (~1 Year)
COMPLETED
|
43
|
51
|
|
Long Term Effectiveness (~1 Year)
NOT COMPLETED
|
12
|
7
|
Reasons for withdrawal
| Measure |
Experimental Cognitive Training
Participants will use experimental computerized cognitive training exercises, 1 hour per day, 3 - 5 days per week, for 13 weeks.
computerized cognitive exercises: Each group will perform computerized cognitive exercises, 1 hour per day, 3 - 5 days per week, for 13 weeks. The experimental group will use exercises shown to improve cognition, whereas the comparator group will use exercises without clear beneficial findings.
|
Control Cognitive Exercises
Participants will use control computerized cognitive activities, 1 hour per day, 3 - 5 days per week, for 13 weeks.
computerized cognitive exercises: Each group will perform computerized cognitive exercises, 1 hour per day, 3 - 5 days per week, for 13 weeks. The experimental group will use exercises shown to improve cognition, whereas the comparator group will use exercises without clear beneficial findings.
|
|---|---|---|
|
Short-term Effectiveness (~13 Weeks)
Withdrawal by Subject
|
7
|
8
|
|
Short-term Effectiveness (~13 Weeks)
non-compliant
|
10
|
7
|
|
Short-term Effectiveness (~13 Weeks)
screen fail
|
1
|
0
|
|
Long Term Effectiveness (~1 Year)
Lost to Follow-up
|
3
|
3
|
|
Long Term Effectiveness (~1 Year)
Death
|
2
|
0
|
|
Long Term Effectiveness (~1 Year)
Withdrawal by Subject
|
6
|
2
|
|
Long Term Effectiveness (~1 Year)
moved away
|
1
|
2
|
Baseline Characteristics
Cognitive Training and Practice Effects in Mild Cognitive Impairment
Baseline characteristics by cohort
| Measure |
Experimental Cognitive Training
n=55 Participants
Participants will use experimental computerized cognitive training exercises, 1 hour per day, 3 - 5 days per week, for 13 weeks.
computerized cognitive exercises: Each group will perform computerized cognitive exercises, 1 hour per day, 3 - 5 days per week, for 13 weeks. The experimental group will use exercises shown to improve cognition, whereas the comparator group will use exercises without clear beneficial findings.
|
Control Cognitive Exercises
n=58 Participants
Participants will use control computerized cognitive activities, 1 hour per day, 3 - 5 days per week, for 13 weeks.
computerized cognitive exercises: Each group will perform computerized cognitive exercises, 1 hour per day, 3 - 5 days per week, for 13 weeks. The experimental group will use exercises shown to improve cognition, whereas the comparator group will use exercises without clear beneficial findings.
|
Total
n=113 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
74.9 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
75.0 years
STANDARD_DEVIATION 5.8 • n=7 Participants
|
75.0 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
62 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 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
|
54 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
111 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
|
55 participants
n=5 Participants
|
58 participants
n=7 Participants
|
113 participants
n=5 Participants
|
|
one week practice effects
|
-0.4 z-score units
STANDARD_DEVIATION 0.7 • n=5 Participants
|
-0.4 z-score units
STANDARD_DEVIATION 0.7 • n=7 Participants
|
-0.4 z-score units
STANDARD_DEVIATION 0.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: 13 weeksPopulation: Mixed effects model
This is a composite of six subtests of the Repeatable Battery for the Assessment of Neuropsychological Status. It is a standard score (mean=100, standard deviation=15), with a range of approximately 45 - 145, with higher scores indicating better outcome.
Outcome measures
| Measure |
Experimental Cognitive Training
n=55 Participants
Participants will use experimental computerized cognitive training exercises, 1 hour per day, 3 - 5 days per week, for 13 weeks.
computerized cognitive exercises: Each group will perform computerized cognitive exercises, 1 hour per day, 3 - 5 days per week, for 13 weeks. The experimental group will use exercises shown to improve cognition, whereas the comparator group will use exercises without clear beneficial findings.
|
Control Cognitive Exercises
n=58 Participants
Participants will use control computerized cognitive activities, 1 hour per day, 3 - 5 days per week, for 13 weeks.
computerized cognitive exercises: Each group will perform computerized cognitive exercises, 1 hour per day, 3 - 5 days per week, for 13 weeks. The experimental group will use exercises shown to improve cognition, whereas the comparator group will use exercises without clear beneficial findings.
|
|---|---|---|
|
Auditory Memory Attention Index
|
89.0 standard score units
Standard Deviation 13.1
|
94.3 standard score units
Standard Deviation 12.1
|
Adverse Events
Experimental Cognitive Training
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Control Cognitive Exercises
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place