Software Treatment for Actively Reducing Severity of ADHD as Adjunctive Treatment to Stimulant

NCT03649074 | Completed Results FDA Device

• 1 other identifier: 001S-A
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine the effects of combining AKL-T01 (with AKL-X01 symptom tracking) as adjunctive treatment to stimulant medication, and to understand the effects of AKL-T01 treatment (with AKL-X01 symptom tracking) in participants not recently on medication.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHD

Outcome Measures

Primary Outcomes (2)

• Impairment Rating Scale, Overall Impairment (Change From Baseline to Posttreatment) in Cohort 1: Stimulant

  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.

  Day 0 to Day 28

• Impairment Rating Scale, Overall Impairment (Change From Baseline to Posttreatment) in Cohort 2: Non-Stimulant

  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.

  Day 0 to Day 28

Secondary Outcomes (6)

• ADHD-RS Total (Change From Baseline to Posttreatment) - Cohort 1: Stimulant

  Day 0 to Day 28

• ADHD-RS Total (Change From Baseline to Posttreatment) - Cohort 2: Non-Stimulant

  Day 0 to Day 28

• CGI-I (at Posttreatment) - Cohort 1: Stimulant

  Day 28

• CGI-I (at Posttreatment) - Cohort 2: Non-Stimulant

  Day 28

• Change TOVA Attention Composite Score (ACS) - Cohort 1: Stimulant

  Day 0 to Day 28

Study Arms (1)

AKL-T01

EXPERIMENTAL

AKL-T01 digital treatment.

Device: AKL-T01

Interventions

AKL-T01 DEVICE

AKL-T01 multitasking digital treatment. AKL-T01 multitasking treatment employs perceptual discrimination attention/memory task as well as a continuous motor "driving" task.

AKL-T01

Eligibility Criteria

• Age: 8 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male or female, ages 8 years 0 months to 14 years 9 months (inclusive), at the time of parental informed consent.
• Confirmed ADHD diagnosis (primarily inattentive or combined subtype), at Screening based on DSM-V criteria and established via the MINI-KID administered by a trained clinician.
• Note: Co-morbid diagnoses on the MINI-KID are acceptable provided that ADHD is the primary diagnosis and the co-morbid diagnoses will not confound study data (per the Investigator's judgment).
• Currently experiencing sub-optimal treatment of ADHD, based upon results of Clinical Global Impression-Severity score.
• Impairment Rating Scale (Parent Report) score of ≥ 3 at Screening.
• Ability to follow written and verbal instructions (English), as assessed by the PI and/or study coordinator.
• Estimated IQ score \> 80 as assessed by the Kaufmann Brief Intelligence Test, Second Edition (KBIT-II).
• Ability to comply with all testing, requirements, study procedures, and availability for the duration of the study.
• Provision of signed and dated parental informed consent form and assent form.
• Participant's parent and/or caregiver has access any of the following Apple™ or Android™ smart phone and/or mobile devices (for accessing AKL-X01 application): Apple iPhone 6, 6+, 7, 8, 10; Android Samsung Galaxy S7, S7 Edge, S8, S8+, S9, S9+; Android Samsung Note 8; Android LG G6, G7, V30, K20. Apple mobile devices must be running iOS 11.2+. Android mobile devices must be running Nougat or Marshmallow.
• For Cohort 1 (stimulant), participant must be stable\*\* on stimulant medication, at an approved FDA dose , for ≥ 30 days prior to enrollment (may also be one stimulant plus a booster, provided that the dose is stable and does not change throughout the course of the trial).
• \*\*Note: Medication stability is defined as:
• Moderate response on stimulant, but still room for improvement
• Dose unchanged within past 30 days, but other doses have been tried previously without improvement
• Currently taking stimulant, but parent and/or caregiver wishes not to increase dosage for any reason

You may not qualify if:

• Current, controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis , based on MINI-KID and subsequent clinical interviewing, with significant symptoms including but not limited to:
• post-traumatic stress disorder
• psychosis
• bipolar illness
• pervasive developmental disorder
• severe obsessive compulsive disorder
• severe depressive
• severe anxiety disorder
• conduct disorder
• other symptomatic manifestations that in the opinion of the Investigator may confound study data/assessments.
• Participants with clinical history of learning disorders will be allowed to participate, provided the disorder does not impact their ability to participate in the trial based on PI judgment.
• Participants who are currently treated with a non-stimulant medication for ADHD (i.e., atomoxetine, clonidine, guanfacine).
• Participants diagnosed with ADHD Hyperactive-Impulsive subtype, based upon score on the MINI-KID interview.
• Participants showing no room for improvement, or those refractory to non-intensive ADHD treatment.
• Initiation within the last 4 weeks from the time of consent of behavioral therapy. Participants who have been in behavior therapy consistently for more than 4 weeks may participate provided their therapy frequency and intensity is unchanged during the course of the study. Participants planning on changing or initiating behavior therapy during the course of the study will be excluded.

Sponsors & Collaborators

• Akili Interactive Labs, Inc.: lead

Study Sites (2)

Melmed Center

Scottsdale, Arizona, 85254, United States

Location

Center for Psychiatry and Behavioral Medicine

Las Vegas, Nevada, 89128, United States

Location

Related Publications (1)

• Flannery JE, Hinshaw SP, Kollins SH, Stamatis CA. Secondary analyses of sex differences in attention improvements across three clinical trials of a digital therapeutic in children, adolescents, and adults with ADHD. BMC Public Health. 2024 Apr 29;24(1):1195. doi: 10.1186/s12889-024-18597-5.

  PMID: 38685016 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Clinical Operations and Research Manager
• Organization: Akili Interactive

dfarlow@akiliinteractive.com

8572543399

Study Officials

• Daniel Lazkowitz, MD, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study will enroll participants into one of two cohorts according to stimulant status. Both cohorts will be assigned to AKL-T01 (with AKL-X01 symptom tracking).

Study Record Dates

• First Submitted: August 23, 2018
• First Posted: August 28, 2018
• Study Start: December 28, 2018
• Primary Completion: September 23, 2019
• Study Completion: September 23, 2019
• Last Updated: August 9, 2023
• Results First Posted: August 9, 2023

Record last verified: 2023-07

Locations

US (2)