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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

93 participants

Primary outcome timeframe

At 3 months (post-intervention)

Results posted on

2026-07-13

Participant Flow

One participant was withdrawn by the investigator prior to the start of the intervention.

Participant milestones

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

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

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

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

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

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

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)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Active Comparator (Non-Speeded Training)

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

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

Mouna Attarha, PhD

Posit Science Corporation

Phone: Phone: 415-394-3100

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place