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Intergenerational Behavioral Intervention to Enhance Physical Activity in Older Adults at Risk for Alzheimer's Disease

The Healthy Aging Brain Study: A Remote Behavioral Intervention to Enhance Physical Activity in Older Adults.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06038643
Acronym
HABS
Enrollment
76
Registered
2023-09-15
Start date
2023-10-08
Completion date
2024-05-30
Last updated
2025-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Physical Inactivity

Keywords

Risk Factors, Disease Prevention, Alzheimer's Disease, Motivation

Brief summary

This is a four-week pilot randomized controlled trial of a behavioral intervention in older adults at risk for Alzheimer's disease. Older participants are a subgroup from the PREVENT-AD longitudinal cohort. We will test whether a four-week intergenerational social motivation using a technology-based platform (intervention group) enhances physical activity relative to a control group.

Detailed description

This study is a two-arm, single-site randomized controlled trial to test whether a four-week technology-based intergenerational social motivation intervention enhances physical activity in 60 cognitively unimpaired older adults with a first-degree history of Alzheimer's disease. These at-risk older adults will be recruited as a subgroup from a longitudinal cohort at McGill University, PREVENT-AD. At the outset, half of the participants will be randomized to the intergenerational social motivation condition (intervention group) and the other half will be randomized to the control group (1:1). A multimodal AD risk score based on older participants' already acquired AD biomarker, health and cognitive data will be used as strata for randomization to ensure equal assignment of high-risk participants to Intervention and control groups, using a permuted block method with random blocks. The primary outcome is an increase in step count as measured by accelerometer. Secondary outcomes are an increase in total physical activity, mood, generativity, cognition, and loneliness. After an initial visit consisting of behavioral testing and structural and functional MRI, participants in the intervention group will be paired with younger adults (14 to 40 years) to form intergenerational dyads. Younger adults are either a family member of the older adult or a younger adult recruited from the community. Participants in the intervention group will receive personalized, positive daily messages over a four-week period via their device using the 'Our Family Garden' technology platform. These daily messages combine (1) pro-social goals (donation to charity after reaching exercise goals), (2) intergenerational social engagement, and (3) positive personalized messages from their younger study partners. This study will have 6 visits over a 2-month period in addition to the four-week intervention period (3 months total). Cognitive and behavioral data will be collected at each visit and physical activity data will be collected over the intervention period. The primary endpoint is defined as the end of the initial period. Data collected are stored in one of three ways; (1) Physical activity monitoring data are extracted from their respective software packages and uploaded directly to a secure data storage environment at a high-performance computing facility. All pen-and-paper psychosocial and neuropsychological assessments are scored and entered in REDCap. Computerized psychosocial assessments are collected directly in REDCap and computerized neuropsychological assessments are entered in REDCap. TextMagic is used to distribute the daily intervention messages. Collected and anonymized survey data are stored on the web application behind an administrative login developed with Django, a high-level Python web framework. All data from REDCap will be exported to CSV files using the data de-identification feature for subsequent analysis with R and SPSS statistical analysis packages. After compiling all data across the 3 different data servers, data will be checked for completeness and correctness using frequency distributions (for missing data and out-of-range values). For the final dataset, the multiple imputations by chained equations (MICE) will be used to input missing values with 10 imputations.

Interventions

BEHAVIORALMotivational behavioural intervention and daily activities monitoring

Social motivation manipulation, self-transcendence daily messaging, and daily activities monitoring through accelerometry. Participants in this arm will have a study partner who receives daily feedback on the main participant's daily step count.

BEHAVIORALActive Control

Daily activities monitored through accelerometry.

Sponsors

Montreal Neurological Institute and Hospital
CollaboratorOTHER
McGill University
CollaboratorOTHER
National Institute on Aging (NIA)
CollaboratorNIH
Douglas Mental Health University Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Intervention model description

Intergenerational Social Motivation Behavioral Intervention using a Technology-based Platform Our research will test an innovative, technology-based, and readily scalable cross-generational social behavior intervention to enhance physical activity in at-risk older adults through a randomized controlled trial.

Eligibility

Sex/Gender
ALL
Age
60 Years to 95 Years
Healthy volunteers
Yes

Inclusion criteria

Main Participant Inclusion criteria: Men and women \> 60 years Who are current participants of the PREVENT-AD Longitudinal Cohort at McGill University. No contraindications to MRI Imaging. Normal cognition Not exercising more than 150 minutes of moderate-intensity exercise per week or sitting more than 8 hours per day AND responded yes to the question Do you want to increase your physical activity? Fluency in English or French Access to a computer or smartphone with internet Normal or corrected-to-normal vision based on the minimal 20/20 standard Ambulatory without significant increase in pain with walking or the assistance of walking devices Main Participant

Exclusion criteria

Primary care physician does not approve additional physical activity An inability to ambulate without the assistance of another person or severe pain Any unstable medical condition: * History of a psychiatric illness including schizophrenia or Attention Deficit Hyperactivity Disorder (ADHD). History of anxiety or depression accepted if stable on medication for at least 6 months * Current treatment for cancer - except non-melanoma skin cancer * Neurological condition (e.g., multiple sclerosis, Parkinson's disease, and stroke) * Current alcohol or substance abuse * Current treatment for congestive heart failure, angina, uncontrolled arrhythmia, Deep Venous Thrombosis (DVT) or other unstable cardiovascular condition * Myocardial infarction, coronary artery bypass grafting, angioplasty or other cardiac event in the past six months. Younger Adult Inclusion Criteria: * Can be identified as child or grandchild of participant (biological or adopted), 14 years or older. * Can be a young adult (18 years or older) who is not a relative of the main participant, in case a grandchild or child is not available. * Stable on antidepressants for more than 6 months. * In contact with the primary participant more than once per 12 months at baseline * Lives anywhere in Canada if 18 years and older, or anywhere accessible by mail in Quebec if 14 years and older but younger than 18 years. * Normal or corrected-to-normal vision based on the minimal 20/20 standard to complete the cognitive tasks * Able to speak, read, and write English or French * No diagnosis of neurological disease or unstable health condition Study Partner

Design outcomes

Primary

MeasureTime frameDescription
Total Step Count (Average Steps/Day)4-weekThis metric quantifies the change in the average number of steps taken each day, from the baseline period to the 4-week period. It is a marker of change in habitual ambulatory activity.

Secondary

MeasureTime frameDescription
Generativity - Achievement4 weeksThis questionnaire measures generativity, which refers to the concern or desire individuals have to contribute to the well-being and development of future generations. Generative evaluates the extent to which individuals are motivated by generative concerns, including the desire to impact others and future generations; the Achievement subscale specifically captures the orientation toward personal goal attainment, mastery, and the pursuit of success as expressions of generativity. Scores for the generative achievement subscale ranged between 6 and 36, with higher scores indicating greater generative achievement.
Test My Brain Digital Neuropsychology Toolkit - Backwards Digit Span4 weeksThe TestMyBrain Digital Neuropsychology Toolkit Backwards Digit Span assesses working memory by requiring individuals to recall sequences of numbers in reverse order. In the backward version, the participant is shown a series of numbers in increasing length and asked to recall the numbers in reverse order. This is a test of short-term memory and working memory. This test was adapted from the Wechsler Adult Intelligence Scales. Scores go from 1 to 10. Higher scores are better.
Loneliness4 weeksUniversity of California, Los Angeles (UCLA) Loneliness Scale. A higher average score indicates greater loneliness. Possible scores: min. 20, max. 80.
Modified Differential Emotions Scale (mDES) Positive Emotions4 weeksThe Modified Differential Emotions Scale (mDES) Positive Emotions subscale measures the intensity of positive emotional experiences such as joy, gratitude, love, and hope. Possible scores: min. 0, max. 80 A higher score indicates greater emotional intensity or frequency of the emotions assessed.
Generativity Desire4 weeksThe Generative Test measures generativity, which refers to the concern or desire individuals have to contribute to the well-being and development of future generations. The Desire subscale specifically assesses the emotional motivation and intrinsic longing to nurture, support, and positively impact others and future generations. Scores for the generative desire subscale ranged between 7 and 42, with higher scores indicating greater generative desire.
Test My Brain Digital Neuropsychology Toolkit - Choice Reaction Time4 weeksThe TestMyBrain Digital Neuropsychology Toolkit Choice Reaction Time task measures processing speed and attention by assessing how quickly individuals respond to different stimuli.
The Modified Differential Emotions Scale (mDES) Negative Emotions4 weeksThe Modified Differential Emotions Scale (mDES) Negative Emotions subscale measures the intensity of negative emotional experiences such as sadness, anger, fear, and shame. Possible scores: min. 0, max. 80 A higher score indicates greater emotional intensity or frequency of the emotions assessed.
Test My Brain Digital Neuropsychology Toolkit - Forward Digit Span4 weeksThe TestMyBrain Digital Neuropsychology Toolkit Forward Digit Span task measures short-term memory by requiring individuals to recall sequences of numbers in the order presented. In the forward version of TMB Digit Span, the participant is shown a series of numbers in increasing length and asked to recall the numbers in the order displayed. This is a test of short-term memory. This test was adapted from the Wechsler Adult Intelligence Scales. Scores go from 1 to 11. Higher scores are better.
Test My Brain Digital Neuropsychology Toolkit - Gradual Onset Continuous Performance C4 weeksThe TestMyBrain Digital Neuropsychology Toolkit Gradual Onset Continuous Performance Task measures sustained attention and inhibitory control by requiring individuals to detect target stimuli amid gradually changing non-targets. In this go/no-go test, the participant presses a button for each city image and withholds button presses for mountain images. This is a test of cognitive control, sustained attention, and response inhibition. Values can be from -1.5 to +1.5. Higher scores indicate better performance. The CPT.C score is a measure of response criterion, or how quickly and/or impulsively the participant tended to respond. Higher scores represent greater response impulsivity.
Test My Brain Digital Neuropsychology Toolkit - Gradual Onset Continuous Performance D4 weeksThe TestMyBrain Digital Neuropsychology Toolkit Gradual Onset Continuous Performance Task (D) assesses sustained attention and response inhibition by requiring individuals to monitor and respond to target stimuli within a dynamic visual stream. In this go/no-go test, the participant presses a button for each city image and withholds button presses for mountain images. This is a test of cognitive control, sustained attention, and response inhibition. The CPT.D score is a measure of discrimination performance, related to how accurately the participant was able to respond to mountains and scenes. Higher scores represent better performance. Values can be from 1 to 4. Higher scores indicate better performance.
Test My Brain Digital Neuropsychology Toolkit - Matrix Reasoning4 weeksThe TestMyBrain Digital Neuropsychology Toolkit Matrix Reasoning task measures abstract reasoning and fluid intelligence by requiring individuals to identify patterns and complete visual matrices. In Test my Brain Matrix Reasoning, the participant selects which smaller image completes the pattern in the larger image. This is a test of visual reasoning and general cognitive ability. This test was adapted from the Wechsler Adult Intelligence Scales. Scores go from 2 to 32. Higher scores are better.
Test My Brain Digital Neuropsychology Toolkit - Serial Reaction Time4 weeks.The TestMyBrain Digital Neuropsychology Toolkit Serial Reaction Time task measures implicit learning and motor sequence acquisition by assessing response speed to repeating and random stimulus patterns. In the TMB Serial Reaction Time task, higher scores in seconds (i.e., longer reaction times) indicate: Reduced processing speed Lower motor or attentional efficiency Weaker implicit sequence learning
Test My Brain Digital Neuropsychology Toolkit - Visual Paired Associates4 weeksThe TestMyBrain Digital Neuropsychology Toolkit Visual Paired Associates task measures associative memory by requiring individuals to learn and recall visual symbol pairs. In this test, the participant memorizes a set of picture pairs. Then, after completing TMB Digit Symbol Matching (90 sec), the participant selects which pictures were paired together. TMB Visual PA is a test of visual episodic memory. In TMB Digit SM, the participant matches as many number/symbol pairs as possible in 90 seconds. This is a test of processing speed. Scores go from 4 to 23. Higher scores are better.
Test My Brain Digital Neuropsychology Toolkit - Digit Symbol Matching4 weeksThe TestMyBrain Digital Neuropsychology Toolkit Digit Symbol Matching task measures processing speed, attention, and visual-motor coordination by requiring rapid matching of symbols to corresponding numbers.

Countries

Canada

Participant flow

Participants by arm

ArmCount
Intervention
Social motivation intervention, self-transcendence daily messages, and daily accelerometry. Motivational behavioural intervention and daily activities monitoring: Social motivation manipulation, self-transcendence daily messaging, and daily activities monitoring through accelerometry. Participants in this arm will have a study partner who receives daily feedback on the main participant's daily step count.
26
Active Control
Daily accelerometry. Active Control: Daily activities monitored through accelerometry.
36
Total62

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyExcluded (not longer fulfilled enrollment criteria)10
Overall StudyWithdrawal by Subject94

Baseline characteristics

CharacteristicActive ControlTotalIntervention
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
32 Participants54 Participants22 Participants
Age, Categorical
Between 18 and 65 years
4 Participants8 Participants4 Participants
Age, Continuous70.97 years
STANDARD_DEVIATION 5.36
70.48 years
STANDARD_DEVIATION 4.95
69.81 years
STANDARD_DEVIATION 4.32
Alzheimer's Disease Risk
Higher Risk
17 Participants25 Participants8 Participants
Alzheimer's Disease Risk
Lower Risk
19 Participants37 Participants18 Participants
APOE4 genotype
APOE4 carriers
16 Participants24 Participants8 Participants
APOE4 genotype
APOE4 non-carriers
20 Participants38 Participants18 Participants
Body Mass Index26.48 kg/m²
STANDARD_DEVIATION 4.56
26.86 kg/m²
STANDARD_DEVIATION 4.74
27.39 kg/m²
STANDARD_DEVIATION 5.03
Diastolic Blood Pressure74.42 mmHg
STANDARD_DEVIATION 6.58
74.53 mmHg
STANDARD_DEVIATION 7.21
74.69 mmHg
STANDARD_DEVIATION 8.14
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
36 Participants62 Participants26 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Language
English
5 Participants9 Participants4 Participants
Language
French
31 Participants53 Participants22 Participants
Mild Cognitive Impairment
Cognitively Unimpaired
30 Participants50 Participants20 Participants
Mild Cognitive Impairment
Mild Cognitive Impairment
6 Participants12 Participants6 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants1 Participants1 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
36 Participants61 Participants25 Participants
Region of Enrollment
Canada
36 participants62 participants26 participants
Sex: Female, Male
Female
29 Participants44 Participants15 Participants
Sex: Female, Male
Male
7 Participants18 Participants11 Participants
Steps per day3881.07 Steps/day
STANDARD_DEVIATION 2978.81
4025.20 Steps/day
STANDARD_DEVIATION 3051.94
4224.77 Steps/day
STANDARD_DEVIATION 3149.72
Systolic Blood Pressure128.22 mmHg
STANDARD_DEVIATION 14.79
127.21 mmHg
STANDARD_DEVIATION 15.38
125.81 mmHg
STANDARD_DEVIATION 16.36
Test my Brain Backwards Digit Span4.94 Score on a scale
STANDARD_DEVIATION 1.76
5.08 Score on a scale
STANDARD_DEVIATION 1.81
5.28 Score on a scale
STANDARD_DEVIATION 1.88
Test my Brain Digit Symbol Matching35.53 Score on a scale
STANDARD_DEVIATION 8.85
35.72 Score on a scale
STANDARD_DEVIATION 8.06
36 Score on a scale
STANDARD_DEVIATION 6.95
Test my Brain Forward Digit Span6.0 Score on a scale
STANDARD_DEVIATION 1.99
6.35 Score on a scale
STANDARD_DEVIATION 1.86
6.84 Score on a scale
STANDARD_DEVIATION 1.57
Test my Brain Gradual Onset Continuous Performance Test (C)0.33 Score on a scale
STANDARD_DEVIATION 0.43
0.35 Score on a scale
STANDARD_DEVIATION 0.43
0.38 Score on a scale
STANDARD_DEVIATION 0.43
Test my Brain Matrix Reasoning21.14 Score on a scale
STANDARD_DEVIATION 6.8
21.25 Score on a scale
STANDARD_DEVIATION 7.17
21.4 Score on a scale
STANDARD_DEVIATION 7.8
Test my Brain Visual Paired Associates Matching14.9 Score on a scale
STANDARD_DEVIATION 4.3
14.73 Score on a scale
STANDARD_DEVIATION 4.3
14.5 Score on a scale
STANDARD_DEVIATION 4.3
TMB Choice Reaction Time1304.72 seconds
STANDARD_DEVIATION 639.63
1265.42 seconds
STANDARD_DEVIATION 532.66
1208.83 seconds
STANDARD_DEVIATION 327.14
TMB Gradual Onset Continuous Performance Test (D)2.58 scores on a scale
STANDARD_DEVIATION 0.96
2.64 scores on a scale
STANDARD_DEVIATION 0.88
2.71 scores on a scale
STANDARD_DEVIATION 0.77
TMB Serial Reaction Time388.13 seconds
STANDARD_DEVIATION 103.15
378.54 seconds
STANDARD_DEVIATION 92.6
364.73 seconds
STANDARD_DEVIATION 74.73
Years of Education15.97 years
STANDARD_DEVIATION 3.55
16.02 years
STANDARD_DEVIATION 3.33
16.08 years
STANDARD_DEVIATION 3.07

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 360 / 40
other
Total, other adverse events
0 / 360 / 40
serious
Total, serious adverse events
0 / 360 / 40

Outcome results

Primary

Total Step Count (Average Steps/Day)

This metric quantifies the change in the average number of steps taken each day, from the baseline period to the 4-week period. It is a marker of change in habitual ambulatory activity.

Time frame: 4-week

Population: Participants included in the analysis were those who completed the study.

ArmMeasureValue (MEAN)Dispersion
InterventionTotal Step Count (Average Steps/Day)5648.91 Steps/dayStandard Deviation 4033.49
Active ControlTotal Step Count (Average Steps/Day)3809.62 Steps/dayStandard Deviation 2833.25
p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary

Generativity - Achievement

This questionnaire measures generativity, which refers to the concern or desire individuals have to contribute to the well-being and development of future generations. Generative evaluates the extent to which individuals are motivated by generative concerns, including the desire to impact others and future generations; the Achievement subscale specifically captures the orientation toward personal goal attainment, mastery, and the pursuit of success as expressions of generativity. Scores for the generative achievement subscale ranged between 6 and 36, with higher scores indicating greater generative achievement.

Time frame: 4 weeks

Population: Participants included in the analysis were those who completed the Generativity questionnaire.

ArmMeasureValue (MEAN)Dispersion
InterventionGenerativity - Achievement25.09 scoreStandard Deviation 5.18
Active ControlGenerativity - Achievement22.58 scoreStandard Deviation 5.88
Secondary

Generativity Desire

The Generative Test measures generativity, which refers to the concern or desire individuals have to contribute to the well-being and development of future generations. The Desire subscale specifically assesses the emotional motivation and intrinsic longing to nurture, support, and positively impact others and future generations. Scores for the generative desire subscale ranged between 7 and 42, with higher scores indicating greater generative desire.

Time frame: 4 weeks

Population: Participants included in the analysis had completed the Generativity questionnaire.

ArmMeasureValue (MEAN)Dispersion
InterventionGenerativity Desire31.67 scoreStandard Deviation 6.13
Active ControlGenerativity Desire29.72 scoreStandard Deviation 7.05
Secondary

Loneliness

University of California, Los Angeles (UCLA) Loneliness Scale. A higher average score indicates greater loneliness. Possible scores: min. 20, max. 80.

Time frame: 4 weeks

ArmMeasureValue (MEAN)Dispersion
InterventionLoneliness53.71 scoreStandard Deviation 23.89
Active ControlLoneliness44.87 scoreStandard Deviation 19.25
Secondary

Modified Differential Emotions Scale (mDES) Positive Emotions

The Modified Differential Emotions Scale (mDES) Positive Emotions subscale measures the intensity of positive emotional experiences such as joy, gratitude, love, and hope. Possible scores: min. 0, max. 80 A higher score indicates greater emotional intensity or frequency of the emotions assessed.

Time frame: 4 weeks

ArmMeasureValue (MEAN)Dispersion
InterventionModified Differential Emotions Scale (mDES) Positive Emotions3.38 scoreStandard Deviation 0.69
Active ControlModified Differential Emotions Scale (mDES) Positive Emotions3.40 scoreStandard Deviation 0.75
Secondary

Test My Brain Digital Neuropsychology Toolkit - Backwards Digit Span

The TestMyBrain Digital Neuropsychology Toolkit Backwards Digit Span assesses working memory by requiring individuals to recall sequences of numbers in reverse order. In the backward version, the participant is shown a series of numbers in increasing length and asked to recall the numbers in reverse order. This is a test of short-term memory and working memory. This test was adapted from the Wechsler Adult Intelligence Scales. Scores go from 1 to 10. Higher scores are better.

Time frame: 4 weeks

Population: The population included in the analysis were those who completed the Test My Brain Backward Digit Span subtest.

ArmMeasureValue (MEAN)Dispersion
InterventionTest My Brain Digital Neuropsychology Toolkit - Backwards Digit Span6.58 scoreStandard Deviation 1.53
Active ControlTest My Brain Digital Neuropsychology Toolkit - Backwards Digit Span4.89 scoreStandard Deviation 1.83
Comparison: We conducted one-way analyses of covariance (ANCOVAs) to assess the effect of group (intervention vs. control) on post-intervention secondary outcomes, including cognition (Test My Brain Digital Neuropsychology Toolkit). Covariates in all models included age, sex, years of education, APOE4 status, and baseline scores.p-value: <0.01ANCOVA
Secondary

Test My Brain Digital Neuropsychology Toolkit - Choice Reaction Time

The TestMyBrain Digital Neuropsychology Toolkit Choice Reaction Time task measures processing speed and attention by assessing how quickly individuals respond to different stimuli.

Time frame: 4 weeks

Population: The population included in the analysis was those who completed the Test My Brain Choice Reaction Time.

ArmMeasureValue (MEAN)Dispersion
InterventionTest My Brain Digital Neuropsychology Toolkit - Choice Reaction Time1293.08 secondsStandard Deviation 722.89
Active ControlTest My Brain Digital Neuropsychology Toolkit - Choice Reaction Time1136.67 secondsStandard Deviation 389.61
Secondary

Test My Brain Digital Neuropsychology Toolkit - Digit Symbol Matching

The TestMyBrain Digital Neuropsychology Toolkit Digit Symbol Matching task measures processing speed, attention, and visual-motor coordination by requiring rapid matching of symbols to corresponding numbers.

Time frame: 4 weeks

Population: Participants included in the analysis had completed the Test My Brain Digit Symbol Matching subtest.

ArmMeasureValue (MEAN)Dispersion
InterventionTest My Brain Digital Neuropsychology Toolkit - Digit Symbol Matching38.81 scoreStandard Deviation 7.14
Active ControlTest My Brain Digital Neuropsychology Toolkit - Digit Symbol Matching36.83 scoreStandard Deviation 7.85
Secondary

Test My Brain Digital Neuropsychology Toolkit - Forward Digit Span

The TestMyBrain Digital Neuropsychology Toolkit Forward Digit Span task measures short-term memory by requiring individuals to recall sequences of numbers in the order presented. In the forward version of TMB Digit Span, the participant is shown a series of numbers in increasing length and asked to recall the numbers in the order displayed. This is a test of short-term memory. This test was adapted from the Wechsler Adult Intelligence Scales. Scores go from 1 to 11. Higher scores are better.

Time frame: 4 weeks

Population: The population included in the analysis was those who completed the Forward Digit Span.

ArmMeasureValue (MEAN)Dispersion
InterventionTest My Brain Digital Neuropsychology Toolkit - Forward Digit Span6.91 scoreStandard Deviation 1.57
Active ControlTest My Brain Digital Neuropsychology Toolkit - Forward Digit Span6.18 scoreStandard Deviation 1.81
Secondary

Test My Brain Digital Neuropsychology Toolkit - Gradual Onset Continuous Performance C

The TestMyBrain Digital Neuropsychology Toolkit Gradual Onset Continuous Performance Task measures sustained attention and inhibitory control by requiring individuals to detect target stimuli amid gradually changing non-targets. In this go/no-go test, the participant presses a button for each city image and withholds button presses for mountain images. This is a test of cognitive control, sustained attention, and response inhibition. Values can be from -1.5 to +1.5. Higher scores indicate better performance. The CPT.C score is a measure of response criterion, or how quickly and/or impulsively the participant tended to respond. Higher scores represent greater response impulsivity.

Time frame: 4 weeks

Population: The population included in the analysis was those who completed the Test My Brain Gradual Onset Continuous Performance C subtest.

ArmMeasureValue (MEAN)Dispersion
InterventionTest My Brain Digital Neuropsychology Toolkit - Gradual Onset Continuous Performance C0.45 scoreStandard Deviation 0.25
Active ControlTest My Brain Digital Neuropsychology Toolkit - Gradual Onset Continuous Performance C0.40 scoreStandard Deviation 0.36
Secondary

Test My Brain Digital Neuropsychology Toolkit - Gradual Onset Continuous Performance D

The TestMyBrain Digital Neuropsychology Toolkit Gradual Onset Continuous Performance Task (D) assesses sustained attention and response inhibition by requiring individuals to monitor and respond to target stimuli within a dynamic visual stream. In this go/no-go test, the participant presses a button for each city image and withholds button presses for mountain images. This is a test of cognitive control, sustained attention, and response inhibition. The CPT.D score is a measure of discrimination performance, related to how accurately the participant was able to respond to mountains and scenes. Higher scores represent better performance. Values can be from 1 to 4. Higher scores indicate better performance.

Time frame: 4 weeks

Population: The population included in the analysis was those who completed the Test My Brain Gradual Onset Continuous Performance D subtest.

ArmMeasureValue (MEAN)Dispersion
InterventionTest My Brain Digital Neuropsychology Toolkit - Gradual Onset Continuous Performance D2.80 scoreStandard Deviation 0.65
Active ControlTest My Brain Digital Neuropsychology Toolkit - Gradual Onset Continuous Performance D2.87 scoreStandard Deviation 0.91
Secondary

Test My Brain Digital Neuropsychology Toolkit - Matrix Reasoning

The TestMyBrain Digital Neuropsychology Toolkit Matrix Reasoning task measures abstract reasoning and fluid intelligence by requiring individuals to identify patterns and complete visual matrices. In Test my Brain Matrix Reasoning, the participant selects which smaller image completes the pattern in the larger image. This is a test of visual reasoning and general cognitive ability. This test was adapted from the Wechsler Adult Intelligence Scales. Scores go from 2 to 32. Higher scores are better.

Time frame: 4 weeks

Population: The population included in the analysis was those who completed the Test My Brain Matrix Reasoning.

ArmMeasureValue (MEAN)Dispersion
InterventionTest My Brain Digital Neuropsychology Toolkit - Matrix Reasoning22.18 scoreStandard Deviation 6.52
Active ControlTest My Brain Digital Neuropsychology Toolkit - Matrix Reasoning22.58 scoreStandard Deviation 6.04
Secondary

Test My Brain Digital Neuropsychology Toolkit - Serial Reaction Time

The TestMyBrain Digital Neuropsychology Toolkit Serial Reaction Time task measures implicit learning and motor sequence acquisition by assessing response speed to repeating and random stimulus patterns. In the TMB Serial Reaction Time task, higher scores in seconds (i.e., longer reaction times) indicate: Reduced processing speed Lower motor or attentional efficiency Weaker implicit sequence learning

Time frame: 4 weeks.

Population: The population included in the analysis was those who completed the Test My Brain Serial Reaction Time.

ArmMeasureValue (MEAN)Dispersion
InterventionTest My Brain Digital Neuropsychology Toolkit - Serial Reaction Time333.24 secondsStandard Deviation 60.57
Active ControlTest My Brain Digital Neuropsychology Toolkit - Serial Reaction Time384.62 secondsStandard Deviation 96.47
Secondary

Test My Brain Digital Neuropsychology Toolkit - Visual Paired Associates

The TestMyBrain Digital Neuropsychology Toolkit Visual Paired Associates task measures associative memory by requiring individuals to learn and recall visual symbol pairs. In this test, the participant memorizes a set of picture pairs. Then, after completing TMB Digit Symbol Matching (90 sec), the participant selects which pictures were paired together. TMB Visual PA is a test of visual episodic memory. In TMB Digit SM, the participant matches as many number/symbol pairs as possible in 90 seconds. This is a test of processing speed. Scores go from 4 to 23. Higher scores are better.

Time frame: 4 weeks

Population: The population included in the analysis was those who completed the Test My Brain Visual Paired Associates.

ArmMeasureValue (MEAN)Dispersion
InterventionTest My Brain Digital Neuropsychology Toolkit - Visual Paired Associates16.2 scoreStandard Deviation 4.41
Active ControlTest My Brain Digital Neuropsychology Toolkit - Visual Paired Associates16.3 scoreStandard Deviation 3.93
Secondary

The Modified Differential Emotions Scale (mDES) Negative Emotions

The Modified Differential Emotions Scale (mDES) Negative Emotions subscale measures the intensity of negative emotional experiences such as sadness, anger, fear, and shame. Possible scores: min. 0, max. 80 A higher score indicates greater emotional intensity or frequency of the emotions assessed.

Time frame: 4 weeks

ArmMeasureValue (MEAN)Dispersion
InterventionThe Modified Differential Emotions Scale (mDES) Negative Emotions1.18 scoreStandard Deviation 0.27
Active ControlThe Modified Differential Emotions Scale (mDES) Negative Emotions1.31 scoreStandard Deviation 0.37

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026