Trial Outcomes & Findings for Software Treatment for Actively Reducing Severity of ADHD as Adjunctive Treatment to Stimulant (NCT NCT03649074)
NCT ID: NCT03649074
Last Updated: 2023-08-09
Results Overview
The Impairment Rating Scale (IRS) is a parent-rated scale that assesses individualized areas of impairment for a child participant and asks parents to make a rating of how significantly these problems impact functioning across a range of domains (social, family, school, self-esteem). Parents describe the primary areas of difficulty for each child and then provide a rating (via a Visual Analog Scale) of how much the difficulties affect the different areas of functioning ranging from (1) "no problem; definitely does not need treatment or special services" to (7) "extreme problem; definitely needs treatment or special services." The total IRS is 8 items, the 8th rating overall impairment. A negative change indicated a decrease in overall impairment.
COMPLETED
NA
206 participants
Day 0 to Day 28
2023-08-09
Participant Flow
Participant milestones
| Measure |
AKL-T01 - Stimulant Cohort
Stable (adherence to a prescribed medication schedule) on a stimulant medication, but are inadequately managed by the stimulant (in the opinion of the investigator). The stimulant is managed by their own physician for at least 30 days before baseline.
|
AKL-T01 - No-Stimulant Cohort
Stable without any stimulant medication for at least 30 days before the baseline.
|
|---|---|---|
|
Overall Study
STARTED
|
130
|
76
|
|
Overall Study
COMPLETED
|
124
|
71
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
Reasons for withdrawal
| Measure |
AKL-T01 - Stimulant Cohort
Stable (adherence to a prescribed medication schedule) on a stimulant medication, but are inadequately managed by the stimulant (in the opinion of the investigator). The stimulant is managed by their own physician for at least 30 days before baseline.
|
AKL-T01 - No-Stimulant Cohort
Stable without any stimulant medication for at least 30 days before the baseline.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
|
Overall Study
Withdrawn by Parent/Guardian
|
1
|
2
|
|
Overall Study
Other
|
1
|
0
|
Baseline Characteristics
Software Treatment for Actively Reducing Severity of ADHD as Adjunctive Treatment to Stimulant
Baseline characteristics by cohort
| Measure |
AKL-T01 - Stimulant Cohort
n=130 Participants
Stable (adherence to a prescribed medication schedule) on a stimulant medication, but are inadequately managed by the stimulant (in the opinion of the investigator). The stimulant is managed by their own physician for at least 30 days before baseline.
|
AKL-T01 - No-Stimulant Cohort
n=76 Participants
Stable without any stimulant medication for at least 30 days before the baseline.
|
Total
n=206 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
10.6 years
STANDARD_DEVIATION 1.75 • n=5 Participants
|
10.5 years
STANDARD_DEVIATION 1.82 • n=7 Participants
|
10.6 years
STANDARD_DEVIATION 1.77 • n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
98 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
154 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
106 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
163 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
21 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
130 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
206 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 to Day 28Population: Participants in the ITT (all participants who received a device) for whom both Day 0 and Day 28 data was able to be collected in full. For the IRS, this population included all participants for whom the eighth item of the questionnaire was completed. In the Stimulant cohort, two participants had the eighth item incomplete.
The Impairment Rating Scale (IRS) is a parent-rated scale that assesses individualized areas of impairment for a child participant and asks parents to make a rating of how significantly these problems impact functioning across a range of domains (social, family, school, self-esteem). Parents describe the primary areas of difficulty for each child and then provide a rating (via a Visual Analog Scale) of how much the difficulties affect the different areas of functioning ranging from (1) "no problem; definitely does not need treatment or special services" to (7) "extreme problem; definitely needs treatment or special services." The total IRS is 8 items, the 8th rating overall impairment. A negative change indicated a decrease in overall impairment.
Outcome measures
| Measure |
AKL-T01 - Stimulant Cohort
n=128 Participants
AKL-T01, or EVO Multi, is a digital intervention that requires the subject to navigate a character through a game-like space, while collecting objects, in a fixed period of time.
The Stimulant Cohort included participants who were stable on a stimulant medication prior to enrollment and throughout the study.
|
|---|---|
|
Impairment Rating Scale, Overall Impairment (Change From Baseline to Posttreatment) in Cohort 1: Stimulant
|
-0.7 score on a scale
Standard Deviation 1.04
|
PRIMARY outcome
Timeframe: Day 0 to Day 28Population: Participants in the ITT (all participants who received a device) for whom both Day 0 and Day 28 data was able to be collected in full. For the IRS, this population included all participants for whom the eighth item of the questionnaire was completed. In the No-Stimulant cohort, two participants had the eighth item incomplete.
The Impairment Rating Scale (IRS) is a parent-rated scale that assesses individualized areas of impairment for a child participant and asks parents to make a rating of how significantly these problems impact functioning across a range of domains (social, family, school, self-esteem). Parents describe the primary areas of difficulty for each child and then provide a rating (via a Visual Analog Scale) of how much the difficulties affect the different areas of functioning ranging from (1) "no problem; definitely does not need treatment or special services" to (7) "extreme problem; definitely needs treatment or special services." The total IRS is 8 items, the 8th rating overall impairment. A negative change indicated a decrease in overall impairment.
Outcome measures
| Measure |
AKL-T01 - Stimulant Cohort
n=74 Participants
AKL-T01, or EVO Multi, is a digital intervention that requires the subject to navigate a character through a game-like space, while collecting objects, in a fixed period of time.
The Stimulant Cohort included participants who were stable on a stimulant medication prior to enrollment and throughout the study.
|
|---|---|
|
Impairment Rating Scale, Overall Impairment (Change From Baseline to Posttreatment) in Cohort 2: Non-Stimulant
|
-0.5 score on a scale
Standard Deviation 0.89
|
SECONDARY outcome
Timeframe: Day 0 to Day 28Population: Participants in the ITT (all participants who received a device) Stimulant Cohort from whom both Day 0 and Day 28 data was collected in full. For the ADHD-RS, this includes all participants for whom all 18 items were completed. In the Stimulant cohort, two participants were missing a response for at least one item of the ADHD-RS.
The ADHD-RS-IV is an 18-item, clinician-administered questionnaire for which a parent respondent rates the frequency of occurrence of ADHD symptoms and behaviors as defined by criteria outlined for ADHD in the DSM-IV. Each item is scored on a 4-point scale ranging from 0 (rarely or never) to 3 (very often) with total scores ranging from 0-54. A higher score indicates more severe ADHD symptoms and behaviors. A negative change in total score indicates improvement from Day 0 to Day 28.
Outcome measures
| Measure |
AKL-T01 - Stimulant Cohort
n=128 Participants
AKL-T01, or EVO Multi, is a digital intervention that requires the subject to navigate a character through a game-like space, while collecting objects, in a fixed period of time.
The Stimulant Cohort included participants who were stable on a stimulant medication prior to enrollment and throughout the study.
|
|---|---|
|
ADHD-RS Total (Change From Baseline to Posttreatment) - Cohort 1: Stimulant
|
-6.1 score on a scale
Standard Deviation 7.18
|
SECONDARY outcome
Timeframe: Day 0 to Day 28Population: Participants in the ITT (all participants who received a device) No-Stimulant Cohort from whom both Day 0 and Day 28 data was collected in full. For the ADHD-RS, this includes all participants for whom all 18 items were completed. In the No-Stimulant cohort, two participants were missing a response for at least one item of the ADHD-RS.
The ADHD-RS-IV is an 18-item, clinician-administered questionnaire for which a parent respondent rates the frequency of occurrence of ADHD symptoms and behaviors as defined by criteria outlined for ADHD in the DSM-IV. Each item is scored on a 4-point scale ranging from 0 (rarely or never) to 3 (very often) with total scores ranging from 0-54. A higher score indicates more severe ADHD symptoms and behaviors. A negative change in total score indicates improvement from Day 0 to Day 28.
Outcome measures
| Measure |
AKL-T01 - Stimulant Cohort
n=74 Participants
AKL-T01, or EVO Multi, is a digital intervention that requires the subject to navigate a character through a game-like space, while collecting objects, in a fixed period of time.
The Stimulant Cohort included participants who were stable on a stimulant medication prior to enrollment and throughout the study.
|
|---|---|
|
ADHD-RS Total (Change From Baseline to Posttreatment) - Cohort 2: Non-Stimulant
|
-7.4 score on a scale
Standard Deviation 9.92
|
SECONDARY outcome
Timeframe: Day 28Population: Participants in the ITT (all participants who received a device) Stimulant Cohort from whom Day 28 data was collected in full. For the CGI-I, this includes all participants for whom the assessment was completed. In the Stimulant cohort, two participants were not assessed at Day 28.
The Clinical Global Impression Scale - Improvement (CGI-I) is a clinician's comparison of the participant's overall clinical condition at follow up to the overall clinical condition at baseline. The CGI-S is a 7-point scale where 1 = Very much improved, 2=Much improved, 3=Minimally improved, 4=No change, 5=Minimally worse, 6=Much worse, and 7=Very much worse. A score of 1, 2, or 3 would indicate overall improvement of ADHD severity.
Outcome measures
| Measure |
AKL-T01 - Stimulant Cohort
n=128 Participants
AKL-T01, or EVO Multi, is a digital intervention that requires the subject to navigate a character through a game-like space, while collecting objects, in a fixed period of time.
The Stimulant Cohort included participants who were stable on a stimulant medication prior to enrollment and throughout the study.
|
|---|---|
|
CGI-I (at Posttreatment) - Cohort 1: Stimulant
|
3.3 score on a scale
Standard Deviation 0.84
|
SECONDARY outcome
Timeframe: Day 28Population: Participants in the ITT (all participants who received a device) No-Stimulant Cohort from whom Day 28 data was collected in full. For the CGI-I, this includes all participants for whom the assessment was completed. In the No-Stimulant cohort, two participants were not assessed at Day 28.
The Clinical Global Impression Scale - Improvement (CGI-I) is a clinician's comparison of the participant's overall clinical condition at follow up to the overall clinical condition at baseline. The CGI-S is a 7-point scale where 1 = Very much improved, 2=Much improved, 3=Minimally improved, 4=No change, 5=Minimally worse, 6=Much worse, and 7=Very much worse. A score of 1, 2, or 3 would indicate overall improvement of ADHD severity.
Outcome measures
| Measure |
AKL-T01 - Stimulant Cohort
n=74 Participants
AKL-T01, or EVO Multi, is a digital intervention that requires the subject to navigate a character through a game-like space, while collecting objects, in a fixed period of time.
The Stimulant Cohort included participants who were stable on a stimulant medication prior to enrollment and throughout the study.
|
|---|---|
|
CGI-I (at Posttreatment) - Cohort 2: Non-Stimulant
|
3.4 score on a scale
Standard Deviation 0.83
|
SECONDARY outcome
Timeframe: Day 0 to Day 28Population: Participants in the ITT (all participants who received a device) Stimulant Cohort from whom Day 0 and Day 28 data was collected in full. For the TOVA, this includes all participants for whom the TOVA was completed. In the Stimulant cohort, two participants did not have complete TOVA assessments at Day 0 or Day 28.
TOVA ACS is a comparison of the subject's scores based on selected measures that persons with an independent diagnosis of ADHD frequently demonstrated. ACS is calculated from variability, response time (RT), and d' Prime using the following formula: ACS = RT Z score (Half 1) + D' Z score (Half 2) + variability Z score (Total) + 1.80 where RT is the average time it takes to respond correctly to a target, D' score is a response discriminability score reflecting the ratio of "hits" to "false alarms", and variability is a measure of consistency of speed of responding based on the standard deviation of the mean correct response times. ACS tells how similar the score is to the ADHD profile. A score of less than -1.8 indicates that the subject had similar performance to a normative ADHD population. A lower score indicates a more severe ADHD profile. The calculation for difference in TOVA ACS is ACS at Baseline (Day 0) minus ACS at Day 28.
Outcome measures
| Measure |
AKL-T01 - Stimulant Cohort
n=128 Participants
AKL-T01, or EVO Multi, is a digital intervention that requires the subject to navigate a character through a game-like space, while collecting objects, in a fixed period of time.
The Stimulant Cohort included participants who were stable on a stimulant medication prior to enrollment and throughout the study.
|
|---|---|
|
Change TOVA Attention Composite Score (ACS) - Cohort 1: Stimulant
|
0.2 z-score
Standard Deviation 3.34
|
SECONDARY outcome
Timeframe: Day 0 to Day 28Population: Participants in the ITT (all participants who received a device) No-Stimulant Cohort from whom Day 0 and Day 28 data was collected in full. For the TOVA, this includes all participants for whom the TOVA was completed. In the No-Stimulant cohort, three participants did not have complete TOVA assessments at Day 0 or Day 28.
TOVA ACS is a comparison of the subject's scores based on selected measures that persons with an independent diagnosis of ADHD frequently demonstrated. ACS is calculated from variability, response time (RT), and d' Prime using the following formula: ACS = RT Z score (Half 1) + D' Z score (Half 2) + variability Z score (Total) + 1.80 where RT is the average time it takes to respond correctly to a target, D' score is a response discriminability score reflecting the ratio of "hits" to "false alarms", and variability is a measure of consistency of speed of responding based on the standard deviation of the mean correct response times. ACS tells how similar the score is to the ADHD profile. A score of less than -1.8 indicates that the subject had similar performance to a normative ADHD population. A lower score indicates a more severe ADHD profile. The calculation for difference in TOVA ACS is ACS at Baseline (Day 0) minus ACS at Day 28.
Outcome measures
| Measure |
AKL-T01 - Stimulant Cohort
n=73 Participants
AKL-T01, or EVO Multi, is a digital intervention that requires the subject to navigate a character through a game-like space, while collecting objects, in a fixed period of time.
The Stimulant Cohort included participants who were stable on a stimulant medication prior to enrollment and throughout the study.
|
|---|---|
|
Change TOVA Attention Composite Score (ACS) - Cohort 2: Non-Stimulant
|
-0.5 z-score
Standard Deviation 2.78
|
Adverse Events
AKL-T01 - Stimulant Cohort
AKL-T01 - No-Stimulant Cohort
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AKL-T01 - Stimulant Cohort
n=130 participants at risk
Stable (adherence to a prescribed medication schedule) on a stimulant medication, but are inadequately managed by the stimulant (in the opinion of the investigator). The stimulant is managed by their own physician for at least 30 days before baseline.
|
AKL-T01 - No-Stimulant Cohort
n=76 participants at risk
Stable without any stimulant medication for at least 30 days before the baseline.
|
|---|---|---|
|
Psychiatric disorders
Frustration tolerance decreased
|
11.5%
15/130 • 84 Days
|
15.8%
12/76 • 84 Days
|
|
Psychiatric disorders
Irritability
|
1.5%
2/130 • 84 Days
|
1.3%
1/76 • 84 Days
|
|
Psychiatric disorders
Agitation
|
0.77%
1/130 • 84 Days
|
0.00%
0/76 • 84 Days
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/130 • 84 Days
|
1.3%
1/76 • 84 Days
|
|
Nervous system disorders
Headache
|
2.3%
3/130 • 84 Days
|
1.3%
1/76 • 84 Days
|
|
Nervous system disorders
Dizziness
|
0.77%
1/130 • 84 Days
|
1.3%
1/76 • 84 Days
|
|
Eye disorders
Asthenopia
|
0.77%
1/130 • 84 Days
|
0.00%
0/76 • 84 Days
|
|
Gastrointestinal disorders
Nausea
|
0.77%
1/130 • 84 Days
|
0.00%
0/76 • 84 Days
|
|
General disorders
Feeling Abnormal
|
0.77%
1/130 • 84 Days
|
0.00%
0/76 • 84 Days
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/130 • 84 Days
|
1.3%
1/76 • 84 Days
|
Additional Information
Clinical Operations and Research Manager
Akili Interactive
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place