Software Treatment for Actively Reducing Severity of ADHD in Adults (STARS ADHD Adult)

NCT05183919 | Completed

• 1 other identifier: Akili-057
• Study Type: interventional
• Target: 223
• Locations: 1 country
• Sites: 14

Brief Summary

The purpose of this study is to evaluate the effects of the videogame-like digital therapy on attentional functioning and symptoms in Adults diagnosed with ADHD.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHD

Outcome Measures

Primary Outcomes (1)

• To evaluate the efficacy of AKL-T01 as determined by the change in a digitally assessed measure, Test of Variables of Attention (TOVA®) Attention Comparison Score (ACS), of sustained and selective attention, after 6 weeks of treatment with AKL-T01

  Test of Variables of Attention (TOVA)-Attention Comparison Score (ACS) of sustained and selective attention. Measures at Day 1 and Exit/Post-Treatment Visit Day 42 TOVA ACS is a comparison of a subject's scores based on selected measures that persons with an independent diagnosis of ADHD frequently demonstrated. ACS is calculated using the following formula: TOVA ACS = 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. 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.

  Study Day 1 to Study Day 42

Secondary Outcomes (1)

• To evaluate the change in ADHD symptoms, as determined by change in the ADHD Rating Scale-IV with adult prompts inattention sub-scale and total scale scores, after 6 weeks of treatment with AKL-T01

  Study Day 1 to Study Day 42

Other Outcomes (11)

• Change (Study Day 1 to Study Day 42) in Adult ADHD Quality of Life Questionnaire (AAQoL) total score

  Study Day 1 to Study Day 42

• Change (Study Day 1 to Study Day 42) in the Adult ADHD Quality of Life Questionnaire (AAQoL) Adult, subscale score for Life Productivity subscale

  Study Day 1 to Study Day 42

• Change (Study Day 1 to Study Day 42) in the Conners' Adult ADHD Rating Scales-Self Report: Short Version (CAARS-S:S) score

  Study Day 1 to Study Day 42

Study Arms (1)

AKL-T01

EXPERIMENTAL

Digital treatment

Other: Digital Treatment

Interventions

Digital Treatment OTHER

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: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults 18 years and older
• Diagnosis of ADHD combined or inattentive type, according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) as confirmed by Mini International Neuropsychiatric Interview (MINI) for Attention - Deficit / Hyperactivity Disorders Studies (Adult) 7.0.2
• Stably on or off ADHD medications for ≥4 weeks prior to study enrollment and throughout the primary 6-week study
• Stably on or off psychoactive medications for ≥4 weeks prior to study enrollment and throughout the 6-week study
• Baseline visit score on the ADHD-RS-IV of ≥ 24
• Baseline visit score on the TOVA-ACS score ≤ -1.8
• Estimated IQ score ≥80 as assessed by the Kaufmann Brief Intelligence Test, Second Edition (KBIT-II)
• Access to and self-report of ability to connect wireless devices to a functional wireless network
• Ability to follow written and verbal instructions (English) as assessed by the PI and/or study coordinator
• Able to comply with all testing and study requirements
• Completion of informed consent form

You may not qualify if:

• Current controlled or uncontrolled, comorbid psychiatric diagnosis with significant symptoms that in the opinion of the Investigator may confound study data/assessments.
• Suicidality assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS)
• Motor condition (e.g., physical deformity of the hands/arms) that prevents game playing as reported by the participant or observed by the Investigator.
• History of moderate or severe substance use disorder within the last 12 months prior to informed consent
• History of seizures (excluding febrile seizures), significant tics, or a current diagnosis of Tourette's Disorder.
• Known sensitivity to playing video games, such as photo-sensitive epilepsy, light-headedness, dizziness, nausea, or motion sickness.
• Color blindness as detected by Ishihara Color Blindness Test
• Positive urine drug screen
• Current or recent (3 months prior to screening) history of heavy smoking defined as the equivalent of greater than or equal to a pack of cigarettes a day
• Any other medical condition that in the opinion of the Investigator may confound study data/assessments.
• Participation in a clinical trial within 3 months prior to screening.
• Previous exposure to Akili products within the 6 months prior to study enrollment
• Plans to initiate new concomitant medications during the primary study, except for common over the counter (OTC) (e.g., ibuprofen, acetaminophen) and prescription medications (e.g., antibiotics) for minor transient ailments.
• Planned initiation of, or significant changes in frequency, of non-pharmacological behavioral therapy during the primary study
• Planned initiation of, or significant changes in frequency of, non-pharmacological trainings with the aim to improve cognition by means of game or app-based cognitive trainings or neurofeedback, during the primary study

Sponsors & Collaborators

• Akili Interactive Labs, Inc.: lead

Study Sites (14)

Melmed Center

Scottsdale, Arizona, 85254, United States

Location

CNS Clinical Research Trials

Garden Grove, California, 92845, United States

Location

Innovative Clinical Research, Inc.

Lauderhill, Florida, 33319, United States

Location

Accel Research Sites

Maitland, Florida, 32751, United States

Location

Behavioral Clinical Research, Inc.

Miami Lakes, Florida, 33016, United States

Location

Midwest Research Group

Saint Charles, Missouri, 63304, United States

Location

Alivation Research

Lincoln, Nebraska, 68526, United States

Location

Center for Psychiatry and Behavioral Medicine, Inc.

Las Vegas, Nevada, 89128, United States

Location

Hassman Research Institute

Berlin, New Jersey, 08009, United States

Location

Albuquerque Neuroscience, Inc.

Albuquerque, New Mexico, 87109, United States

Location

MindPath Care Centers

Raleigh, North Carolina, 27606, United States

Location

IPS Research

Oklahoma City, Oklahoma, 73106, United States

Location

FutureSearch Trials

Dallas, Texas, 75231, United States

Location

Southeast Houston Research, Inc.

Houston, Texas, 77089, United States

Location

Related Publications (2)

• Stamatis CA, Heusser AC, Simon TJ, Ala'ilima T, Kollins SH. Real-time cognitive performance metrics derived from a digital therapeutic for inattention predict ADHD-related clinical outcomes: Replication across three independent trials of AKL-T01. Transl Psychiatry. 2024 Aug 11;14(1):328. doi: 10.1038/s41398-024-03045-0.

  PMID: 39128918 DERIVED

• 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

Study Design

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

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: January 11, 2022
• Study Start: November 29, 2021
• Primary Completion: January 13, 2023
• Study Completion: January 13, 2023
• Last Updated: February 28, 2023

Record last verified: 2023-02

Locations

US (14)