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

  • STATUS
    Recruiting
  • day left to enroll
    1
  • participants needed
    325
  • sponsor
    Akili Interactive Labs, Inc.
Updated on 13 May 2022
hyperactivity

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.

Description

This study is a multi-center, unblinded/non-controlled adaptive design study to evaluate objective attention functioning and ADHD symptoms and impairments in adults with a diagnosis of ADHD (combined or inattentive subtype), stably on or off ADHD medication, after 6 weeks of AKL-T01 treatment.

A maximum of 325 total participants from 12-30 sites will be enrolled.

During the Screening/baseline, participants will undergo screening to evaluate eligibility for the study. Eligible participants will continue onto baseline procedures in the same visit.

Treatment phase (Day 2-42) will involve using the digital therapy at home for each participant. Compliance with treatment/use requirements will be monitored remotely during this phase.

An In-Clinic assessment will be completed on Day 42 to assess key outcomes.

Details
Condition Attention Deficit Hyperactivity Disorder
Treatment Digital Treatment
Clinical Study IdentifierNCT05183919
SponsorAkili Interactive Labs, Inc.
Last Modified on13 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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