Trial Outcomes & Findings for Improving Neurological Health in Aging Via Neuroplasticity-based Computerized Exercise (NCT NCT04149457)
NCT ID: NCT04149457
Last Updated: 2026-07-13
Results Overview
Change from baseline and 3 months (post-intervention) for the 18F-fluoroethoxybenzovesamicol (FEOBV) standardized uptake value ratio (SUVR) in the Anterior Cingulate Cortex as measured through Positron Emission Tomography (PET) ligand imaging. Higher score is better.
COMPLETED
NA
93 participants
At 3 months (post-intervention)
2026-07-13
Participant Flow
One participant was withdrawn by the investigator prior to the start of the intervention.
Participant milestones
| Measure |
Experimental Treatment (Speeded Training)
Computerized plasticity-based adaptive cognitive training requiring a total maximum of 70 treatment sessions, up to 7 sessions per week, 30 minutes per session.
Computerized Plasticity-Based Adaptive Cognitive Training: Thirty minutes of training on computerized exercises that targets visual processing speed, memory, attention and alertness.
|
Active Comparator (Non-Speeded Training)
Commercially available computerized training requiring a total maximum of 70 treatment sessions, up to 7 sessions per week, 30 minutes per session.
Commercially available computerized training: Thirty minutes of training on computerized, casual video games.
|
|---|---|---|
|
Overall Study
STARTED
|
46
|
46
|
|
Overall Study
COMPLETED
|
41
|
41
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
Reasons for withdrawal
| Measure |
Experimental Treatment (Speeded Training)
Computerized plasticity-based adaptive cognitive training requiring a total maximum of 70 treatment sessions, up to 7 sessions per week, 30 minutes per session.
Computerized Plasticity-Based Adaptive Cognitive Training: Thirty minutes of training on computerized exercises that targets visual processing speed, memory, attention and alertness.
|
Active Comparator (Non-Speeded Training)
Commercially available computerized training requiring a total maximum of 70 treatment sessions, up to 7 sessions per week, 30 minutes per session.
Commercially available computerized training: Thirty minutes of training on computerized, casual video games.
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
4
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Improving Neurological Health in Aging Via Neuroplasticity-based Computerized Exercise
Baseline characteristics by cohort
| Measure |
Experimental Treatment (Speeded Training)
n=46 Participants
Computerized plasticity-based adaptive cognitive training requiring a total maximum of 70 treatment sessions, up to 7 sessions per week, 30 minutes per session.
Computerized Plasticity-Based Adaptive Cognitive Training: Thirty minutes of training on computerized exercises that targets visual processing speed, memory, attention and alertness.
|
Active Comparator (Non-Speeded Training)
n=46 Participants
Commercially available computerized training requiring a total maximum of 70 treatment sessions, up to 7 sessions per week, 30 minutes per session.
Commercially available computerized training: Thirty minutes of training on computerized, casual video games.
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72.76 years
STANDARD_DEVIATION 5.25 • n=20 Participants
|
71.04 years
STANDARD_DEVIATION 4.32 • n=20 Participants
|
71.90 years
STANDARD_DEVIATION 4.85 • n=40 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=20 Participants
|
32 Participants
n=20 Participants
|
61 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=20 Participants
|
14 Participants
n=20 Participants
|
31 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
45 Participants
n=20 Participants
|
46 Participants
n=20 Participants
|
91 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=20 Participants
|
44 Participants
n=20 Participants
|
88 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Education
|
16.28 years
STANDARD_DEVIATION 3.53 • n=20 Participants
|
16.63 years
STANDARD_DEVIATION 3.30 • n=20 Participants
|
16.45 years
STANDARD_DEVIATION 3.40 • n=40 Participants
|
|
Native Language - English
|
17 participants
n=20 Participants
|
16 participants
n=20 Participants
|
33 participants
n=40 Participants
|
|
Montreal Cognitive Assessment (MoCA) Total Score
|
26.37 score on a scale
STANDARD_DEVIATION 1.83 • n=20 Participants
|
25.98 score on a scale
STANDARD_DEVIATION 1.84 • n=20 Participants
|
26.17 score on a scale
STANDARD_DEVIATION 1.83 • n=40 Participants
|
|
Geriatric Depression Scale - Short Form (GDS-SF) Total Score
|
1.24 score on a scale
STANDARD_DEVIATION 1.85 • n=20 Participants
|
1.52 score on a scale
STANDARD_DEVIATION 1.91 • n=20 Participants
|
1.38 score on a scale
STANDARD_DEVIATION 1.87 • n=40 Participants
|
PRIMARY outcome
Timeframe: At 3 months (post-intervention)Change from baseline and 3 months (post-intervention) for the 18F-fluoroethoxybenzovesamicol (FEOBV) standardized uptake value ratio (SUVR) in the Anterior Cingulate Cortex as measured through Positron Emission Tomography (PET) ligand imaging. Higher score is better.
Outcome measures
| Measure |
Experimental Treatment (Speeded Training)
n=41 Participants
Computerized plasticity-based adaptive cognitive training requiring a total maximum of 70 treatment sessions, up to 7 sessions per week, 30 minutes per session.
Computerized Plasticity-Based Adaptive Cognitive Training: Thirty minutes of training on computerized exercises that targets visual processing speed, memory, attention and alertness.
|
Active Comparator (Non-Speeded Training)
n=41 Participants
Commercially available computerized training requiring a total maximum of 70 treatment sessions, up to 7 sessions per week, 30 minutes per session.
Commercially available computerized training: Thirty minutes of training on computerized, casual video games.
|
|---|---|---|
|
Change Mean in FEOBV SUVR (Standardized Uptake Value Ratio) Through PET Imaging in the Anterior Cingulate Cortex
|
0.044 Standard Uptake Value Ratio
Interval 0.006 to 82.0
|
0.014 Standard Uptake Value Ratio
Interval -0.026 to 0.054
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At 3 months (post-intervention) and at 6 months (follow-up)The EXAMINER (Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research) is a computer-based battery of executive function tests yielding a single Executive Composite score across three subtests (Flanker, Anti-Saccades, Set-Shifting). The Executive Composite is a latent trait estimate using Empirical Bayes scoring from item-response theory and is therefore unitless and unbounded. For reference, validation studies report mean scores of 0.70 in healthy adults, 0.29 in patients with mild cognitive impairment, and -0.20 in patients with Alzheimer's disease. This outcome reports change in Executive Composite Score from baseline, calculated as the score at 3 months minus baseline and the score at 6 months minus baseline. Higher values indicate better executive functioning.
Outcome measures
| Measure |
Experimental Treatment (Speeded Training)
n=41 Participants
Computerized plasticity-based adaptive cognitive training requiring a total maximum of 70 treatment sessions, up to 7 sessions per week, 30 minutes per session.
Computerized Plasticity-Based Adaptive Cognitive Training: Thirty minutes of training on computerized exercises that targets visual processing speed, memory, attention and alertness.
|
Active Comparator (Non-Speeded Training)
n=41 Participants
Commercially available computerized training requiring a total maximum of 70 treatment sessions, up to 7 sessions per week, 30 minutes per session.
Commercially available computerized training: Thirty minutes of training on computerized, casual video games.
|
|---|---|---|
|
Change Mean in EXAMINER Executive Composite Score
At 3 months
|
0.132 score on a scale
Interval -0.091 to 0.358
|
0.091 score on a scale
Interval -0.131 to 0.314
|
|
Change Mean in EXAMINER Executive Composite Score
At 6 months
|
0.166 score on a scale
Interval -0.075 to 0.411
|
0.163 score on a scale
Interval -0.058 to 0.385
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At 3 months (post-intervention) and at 6 months (follow-up)This is a computerized assessment that serves as a positive control for task learning. Raw scores are defined as the exposure duration at approximately 80% criterion accuracy in milliseconds accuracy in identification of central and peripheral targets. The best possible raw score is 32 milliseconds, and the worst possible score is 3162 milliseconds. Change was calculated as the score at 3 months minus the score at baseline, and as the score at 6 months minus the score at baseline. Lower values in milliseconds reflect better Useful Field of View performance.
Outcome measures
| Measure |
Experimental Treatment (Speeded Training)
n=41 Participants
Computerized plasticity-based adaptive cognitive training requiring a total maximum of 70 treatment sessions, up to 7 sessions per week, 30 minutes per session.
Computerized Plasticity-Based Adaptive Cognitive Training: Thirty minutes of training on computerized exercises that targets visual processing speed, memory, attention and alertness.
|
Active Comparator (Non-Speeded Training)
n=41 Participants
Commercially available computerized training requiring a total maximum of 70 treatment sessions, up to 7 sessions per week, 30 minutes per session.
Commercially available computerized training: Thirty minutes of training on computerized, casual video games.
|
|---|---|---|
|
Change Mean Score in Useful Field of View (UFOV) Assessment
At 3 months
|
1.703 milliseconds
Interval 1.39 to 2.021
|
0.174 milliseconds
Interval -0.166 to 0.512
|
|
Change Mean Score in Useful Field of View (UFOV) Assessment
At 6 months
|
1.666 milliseconds
Interval 1.352 to 1.986
|
0.486 milliseconds
Interval 0.245 to 0.726
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At 3 months (post-intervention) and at 6 months (follow-up)This is a computerized assessment that serves as a positive control for task learning. A single target frequency level required for users to achieve at least 80% accuracy in target and foil identification for a pre-specified target image presented among similar foil images. Target frequency level is recorded as an integer ranging from 1 to 7, where 1 corresponded to the easiest condition (40% target frequency among foils) and 7 represented the most challenging condition (10% target frequency among foils). Change was calculated as the score at 3 months minus the score at baseline, and as the score at 6 months minus the score at baseline. Higher scores indicate better performance.
Outcome measures
| Measure |
Experimental Treatment (Speeded Training)
n=41 Participants
Computerized plasticity-based adaptive cognitive training requiring a total maximum of 70 treatment sessions, up to 7 sessions per week, 30 minutes per session.
Computerized Plasticity-Based Adaptive Cognitive Training: Thirty minutes of training on computerized exercises that targets visual processing speed, memory, attention and alertness.
|
Active Comparator (Non-Speeded Training)
n=41 Participants
Commercially available computerized training requiring a total maximum of 70 treatment sessions, up to 7 sessions per week, 30 minutes per session.
Commercially available computerized training: Thirty minutes of training on computerized, casual video games.
|
|---|---|---|
|
Change Mean Target Frequency Level in Tonic and Phasic Alertness (TAPAT) Assessment
At 3 months
|
1.066 Target frequency level
Interval 0.763 to 1.363
|
0.171 Target frequency level
Interval -0.14 to 0.481
|
|
Change Mean Target Frequency Level in Tonic and Phasic Alertness (TAPAT) Assessment
At 6 months
|
1.179 Target frequency level
Interval 0.918 to 1.435
|
0.294 Target frequency level
Interval -0.002 to 0.585
|
Adverse Events
Experimental Treatment (Speeded Training)
Active Comparator (Non-Speeded Training)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Experimental Treatment (Speeded Training)
n=46 participants at risk
Computerized plasticity-based adaptive cognitive training requiring a total maximum of 70 treatment sessions, up to 7 sessions per week, 30 minutes per session.
Computerized Plasticity-Based Adaptive Cognitive Training: Thirty minutes of training on computerized exercises that targets visual processing speed, memory, attention and alertness.
|
Active Comparator (Non-Speeded Training)
n=46 participants at risk
Commercially available computerized training requiring a total maximum of 70 treatment sessions, up to 7 sessions per week, 30 minutes per session.
Commercially available computerized training: Thirty minutes of training on computerized, casual video games.
|
|---|---|---|
|
Gastrointestinal disorders
mild dry mouth
|
0.00%
0/46 • At 3 months (post-intervention) and at 6 months (follow-up)
|
2.2%
1/46 • Number of events 1 • At 3 months (post-intervention) and at 6 months (follow-up)
|
|
Gastrointestinal disorders
mild strange sensation in the mouth
|
0.00%
0/46 • At 3 months (post-intervention) and at 6 months (follow-up)
|
2.2%
1/46 • Number of events 1 • At 3 months (post-intervention) and at 6 months (follow-up)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place