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Trial Outcomes & Findings for Software Treatment for Actively Reducing Severity of ADHD - Follow Up (NCT NCT02828644)

NCT ID: NCT02828644

Last Updated: 2019-02-12

Results Overview

TOVA API is a comparison of the subject's scores based on selected measures that persons with an independent diagnosis of ADHD frequently demonstrated. The API is calculated from variability, response time, and d' (D Prime) using the following formula: API = Response Time Z score (Half 1) + d' Z score (Half 2) + Variability Z score (Total) + 1.80 where Response Time 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. API tells how similar the score is to the ADHD profile. A score of less than 0 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 API was API at Day 28 minus API at Day 0 of this study.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

175 participants

Primary outcome timeframe

Day 0 to Day 28

Results posted on

2019-02-12

Participant Flow

Participant milestones

Participant milestones
Measure
AKL-T01 (EVO Multi)
AKL-T01, or EVO Multi, is a digital intervention that requires subjects to navigate a character through a game-like space, while collecting objects, in a fixed period of time. The intervention was administered to the subjects during the parent study (Akili-001R, NCT02674633)
AKL-T09 (EVO Words)
AKL-T09, or EVO Words, is a digital intervention that requires subjects to spell as many words as possible, by connecting letters in a game-like grid, in a fixed period of time. The intervention was administered to the subjects during the parent study (Akili-001R, NCT02674633)
Overall Study
STARTED
88
87
Overall Study
COMPLETED
65
65
Overall Study
NOT COMPLETED
23
22

Reasons for withdrawal

Reasons for withdrawal
Measure
AKL-T01 (EVO Multi)
AKL-T01, or EVO Multi, is a digital intervention that requires subjects to navigate a character through a game-like space, while collecting objects, in a fixed period of time. The intervention was administered to the subjects during the parent study (Akili-001R, NCT02674633)
AKL-T09 (EVO Words)
AKL-T09, or EVO Words, is a digital intervention that requires subjects to spell as many words as possible, by connecting letters in a game-like grid, in a fixed period of time. The intervention was administered to the subjects during the parent study (Akili-001R, NCT02674633)
Overall Study
Lost to Follow-up
23
22

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
AKL-T01 (EVO Multi)
n=88 Participants
AKL-T01, or EVO Multi, is a digital intervention that requires subjects to navigate a character through a game-like space, while collecting objects, in a fixed period of time. The intervention was administered to the subjects during the parent study (Akili-001R, NCT02674633)
AKL-T09 (EVO Words)
n=87 Participants
AKL-T09, or EVO Words, is a digital intervention that requires subjects to spell as many words as possible, by connecting letters in a game-like grid, in a fixed period of time. The intervention was administered to the subjects during the parent study (Akili-001R, NCT02674633)
Total
n=175 Participants
Total of all reporting groups
Age, Categorical
<=18 years
88 Participants
n=88 Participants
87 Participants
n=87 Participants
175 Participants
n=175 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=88 Participants
0 Participants
n=87 Participants
0 Participants
n=175 Participants
Age, Categorical
>=65 years
0 Participants
n=88 Participants
0 Participants
n=87 Participants
0 Participants
n=175 Participants
Sex: Female, Male
Female
30 Participants
n=88 Participants
21 Participants
n=87 Participants
51 Participants
n=175 Participants
Sex: Female, Male
Male
58 Participants
n=88 Participants
66 Participants
n=87 Participants
124 Participants
n=175 Participants
Race and Ethnicity Not Collected
—
—
0 Participants
Race and Ethnicity were not collected from any participant.
Region of Enrollment
United States
88 Participants
n=88 Participants
87 Participants
n=87 Participants
175 Participants
n=175 Participants

PRIMARY outcome

Timeframe: Day 0 to Day 28

Population: All subjects who were randomized to the AKL-T01 arm in 001R/NCT02674633, completed 4 weeks of at-home play, and completed the Day 0 and Day 28 visits of this study.

TOVA API is a comparison of the subject's scores based on selected measures that persons with an independent diagnosis of ADHD frequently demonstrated. The API is calculated from variability, response time, and d' (D Prime) using the following formula: API = Response Time Z score (Half 1) + d' Z score (Half 2) + Variability Z score (Total) + 1.80 where Response Time 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. API tells how similar the score is to the ADHD profile. A score of less than 0 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 API was API at Day 28 minus API at Day 0 of this study.

Outcome measures

Outcome measures
Measure
AKL-T01 (EVO Multi)
n=65 Participants
AKL-T01, or EVO Multi, is a digital intervention that requires subjects to navigate a character through a game-like space, while collecting objects, in a fixed period of time. The intervention was administered to the subjects during the parent study (Akili-001R, NCT02674633).
AKL-T09 (EVO Words)
EVO Words is a digital intervention that requires subjects to spell as many words as possible, by connecting letters in a game-like grid, in a fixed period of time. The intervention was administered to the subjects during the parent study (Akili-001R, NCT02674633)
Sustained Effects in Attention From End-of-treatment (Follow-Up Day 0) to Follow-Up Day 28 Within Groups That Were Previously Randomized to Receive 4 Weeks of Digital Therapy
-0.407 z-score
Standard Deviation 2.823
—

SECONDARY outcome

Timeframe: Day 0 to Day 28

Population: All subjects who were enrolled in 001R/NCT02674633, completed 4 weeks of at-home play, and completed the Day 0 and Day 28 visits of this study.

TOVA API is a comparison of the subject's scores based on selected measures that persons with an independent diagnosis of ADHD frequently demonstrated. The API is calculated from variability, response time, and d' (D Prime) using the following formula: API = Response Time Z score (Half 1) + d' Z score (Half 2) + Variability Z score (Total) + 1.80 where Response Time 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. API tells how similar the score is to the ADHD profile. A score of less than 0 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 API was API at Day 28 minus API at Day 0 of this study.

Outcome measures

Outcome measures
Measure
AKL-T01 (EVO Multi)
n=65 Participants
AKL-T01, or EVO Multi, is a digital intervention that requires subjects to navigate a character through a game-like space, while collecting objects, in a fixed period of time. The intervention was administered to the subjects during the parent study (Akili-001R, NCT02674633).
AKL-T09 (EVO Words)
n=65 Participants
EVO Words is a digital intervention that requires subjects to spell as many words as possible, by connecting letters in a game-like grid, in a fixed period of time. The intervention was administered to the subjects during the parent study (Akili-001R, NCT02674633)
Sustained Effects in Attention From End-of-treatment (Follow-Up Day 0) to Follow-Up Day 28 Across Groups That Were Previously Randomized to Receive 4 Weeks of Digital Therapy
-0.407 z-score
Standard Deviation 2.823
-0.615 z-score
Standard Deviation 3.338

Adverse Events

AKL-T01 (EVO Multi)

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

AKL-T09 (EVO Words)

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

Kathryn Jenkins

Akili Interactive Labs

Phone: 7742666693

Results disclosure agreements

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

Restriction type: LTE60