Attention Deficit Hyperactivity DisorderNCT05183919
Software Treatment for Actively Reducing Severity of ADHD in Adults (STARS ADHD Adult)
A study testing Digital Treatment in people with Attention Deficit Hyperactivity Disorder, run by Akili Interactive Labs, Inc. at 14 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Digital Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 223 participants
- Where
- 14 sitesUnited States
- Study dates
- 29 Nov 2021to 13 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Albuquerque Neuroscience, Inc.
Albuquerque, New Mexico, 87109
Hassman Research Institute
Berlin, New Jersey, 08009
FutureSearch Trials
Dallas, Texas, 75231
CNS Clinical Research Trials
Garden Grove, California, 92845
Southeast Houston Research, Inc.
Houston, Texas, 77089
Center for Psychiatry and Behavioral Medicine, Inc.
Las Vegas, Nevada, 89128
Innovative Clinical Research, Inc.
Lauderhill, Florida, 33319
Alivation Research
Lincoln, Nebraska, 68526
Accel Research Sites
Maitland, Florida, 32751
Behavioral Clinical Research, Inc.
Miami Lakes, Florida, 33016
IPS Research
Oklahoma City, Oklahoma, 73106
MindPath Care Centers
Raleigh, North Carolina, 27606
Midwest Research Group
Saint Charles, Missouri, 63304
Melmed Center
Scottsdale, Arizona, 85254
About this study
Official title: A Single Arm, Adaptive Design, Pivotal Trial to Assess the Efficacy of AKL-T01, a Novel Digital Intervention Designed to Improve Attention, in Adults Diagnosed With Attention Deficit Hyperactive Disorder
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.
Read the detailed 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.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Digital Treatment
- Keywords
- ADHD
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital TreatmentOther
AKL-T01 multitasking digital treatment. AKL-T01 multitasking treatment employs perceptual discrimination attention/memory task as well as a continuous motor "driving" task.
| Study group | Role | What they receive |
|---|---|---|
| AKL-T01 | Experimental | Digital treatment Receives: Other: Digital Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Change in the Attention Deficit Hyperactive Disorder (ADHD) Rating Scale-IV inattention sub-scale and total scale scores. Measures taken at Baseline Visit (Day 1) and Exit/Post-Treatment Visit (Day 42).
ADHD Rating Scale-IV is a clinician-administered questionnaire. The questionnaire is an 18-item scale that provides a rating of the severity of symptoms for Inattention and Hyperactivity-Impulsivity. The total score is obtained by adding the Inattention and Hyperactivity-Impulsivity subscale raw scores. Each item is rated on a 4-point scale; None (0), mild (1), moderate (2), severe (3). A higher score indicates more severe ADHD symptoms and behaviors.
Measured: Study Day 1 to Study Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start29 Nov 2021
- Primary completion13 Jan 2023
- Study completion13 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akili Interactive Labs, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05183919
- Sponsor's protocol ID
- Akili-057
- Status last verified
- Feb 2023
- First submitted
- 2 Dec 2021
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39128918Flannery 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.
PubMed 38685016
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Adaptive Design, Pivotal Trial to Assess the Efficacy of AKL-T01, a Novel Digital Intervention Designed to Improve Attention, in Adults Diagnosed With Attention Deficit Hyperactive Disorder
- ClinicalTrials.gov ID
- NCT05183919
- Acronym / sponsor ID
- Akili-057
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- ADHD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- Akili Interactive Labs, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Nov 2021 (actual)
- Primary completion
- 13 Jan 2023 (actual)
- Study completion
- 13 Jan 2023 (actual)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AKL-T01 | Experimental | Other: Digital TreatmentDigital treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital TreatmentAKL-T01 multitasking digital treatment. AKL-T01 multitasking treatment employs perceptual discrimination attention/memory task as well as a continuous motor "driving" task. | Other | AKL-T01 |
Primary outcome
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
Time frame: Study Day 1 to Study Day 42
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.
1 secondary outcome
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
Time frame: Study Day 1 to Study Day 42
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
- Derived from this study: PubMed 39128918Stamatis 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.
- Derived from this study: PubMed 38685016Flannery 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Treatment in people with Attention Deficit Hyperactivity Disorder, run by Akili Interactive Labs, Inc. at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Study Day 1 to Study Day 42). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05183919, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2023; AzTrials last refreshed its copy on 6 Nov 2026.