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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05183919
Recruitment Status : Recruiting
First Posted : January 11, 2022
Last Update Posted : August 18, 2022
Sponsor:
Information provided by (Responsible Party):
Akili Interactive Labs, Inc.

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.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Other: Digital Treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 325 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 29, 2021
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : April 28, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: AKL-T01
Digital treatment
Other: Digital Treatment
AKL-T01 multitasking digital treatment. AKL-T01 multitasking treatment employs perceptual discrimination attention/memory task as well as a continuous motor "driving" task.




Primary Outcome Measures :
  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 [ 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.



Secondary Outcome Measures :
  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 [ Time Frame: Study Day 1 to Study Day 42 ]

    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.



Other Outcome Measures:
  1. Change (Study Day 1 to Study Day 42) in Adult ADHD Quality of Life Questionnaire (AAQoL) total score [ Time Frame: Study Day 1 to Study Day 42 ]

    Change in the Adult ADHD Quality of Life Questionnaire (AAQoL) total score. Measures taken at Baseline Visit (Day 1) and Exit/Post-Treatment Visit (Day 42).

    AAQoL has 29 items to assess health-related quality of life during the past two weeks among adults with ADHD. Each item is rated by patients on a five-point Likert scale, Not at all/ Never (1) to Extremely/Very Often (5). The AAQoL has a total score and four subscale scores: Life Productivity, Psychological Health, Life Outlook, Relationships

    Total and subscale scores are computed by (1) reversing scores for all items except the seven items in the Life Outlook subscale; (2) transforming all item scores to a 0-100 point scale (1=0; 2=25; 3=50; 4=75; 5=100); and (3) summing item scores and dividing by the item count to generate subscale and total scores. The scoring algorithm indicates that the total score can be computed with up to three missing items, and each subscale score can be computed with up to one missing item.


  2. Change (Study Day 1 to Study Day 42) in the Adult ADHD Quality of Life Questionnaire (AAQoL) Adult, subscale score for Life Productivity subscale [ Time Frame: Study Day 1 to Study Day 42 ]

    Change in the Adult ADHD Quality of Life Questionnaire (AAQoL) subscale score for Life Productivity. Measures taken at Baseline Visit (Day 1) and Exit/Post-Treatment Visit (Day 42).

    AAQoL has 29 items to assess health-related quality of life during the past two weeks among adults with ADHD. Each item is rated by patients on a five-point Likert scale ranging from Not at all/ Never (1) to Extremely/Very Often (5). The AAQoL has a total score and four subscale scores.

    The subscale, Life Productivity is 11 items, including getting things done on time, completing projects or tasks, remembering important things, and balancing multiple projects.

    Subscale scores are computed by (1) reversing scores for all items except the seven items in the Life Outlook subscale; (2) transforming all item scores to a 0-100 point scale (1=0; 2=25; 3=50; 4=75; 5=100); and (3) summing item scores and dividing by the item count to generate subscale scores.


  3. Change (Study Day 1 to Study Day 42) in the Conners' Adult ADHD Rating Scales-Self Report: Short Version (CAARS-S:S) score [ Time Frame: Study Day 1 to Study Day 42 ]

    Change in the Conners' Adult ADHD Rating Scales-Self Report: Short Version (CAASRS:S) score. Measures taken at Baseline Visit (Day 1) and Exit/Post-Treatment Visit (Day 42).

    CAASRS:S is a Likert scale, 26-question questionnaire used to rate a patient's current functioning ability. The scores are computed by 0 = Not at all, never; 1 = Just a little, once in a while; 2 = Pretty much, often; and 3 = Very much, very frequently.


  4. Proportion of responders at end of treatment defined as 30% reduction in total ADHD-Rating Scale-IV score [ Time Frame: Study Day 1 to Study Day 42 ]

    A proportion of the reponders with 30% reduction in the total (ADHD) Rating Scale-IV 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.


  5. Proportion of responders at end of treatment defined as 8-point change in Adult ADHD Quality of Life Questionnaire (AAQoL) [ Time Frame: Study Day 1 to Study Day 42 ]

    A proportion of the reponders with an 8-point change in the Adult ADHD Quality of Life Questionnaire (AAQoL) score taken at (Day 1) and Exit/Post-Treatment Visit (Day 42).

    AAQoL has 29 items to assess health-related quality of life during the past two weeks among adults with ADHD. Each item is rated by patients on a five-point Likert scale ranging from Not at all/ Never (1) to Extremely/Very Often (5). The AAQoL yields a total score (based on all 29 items) and four subscale scores.

    Subscale scores are computed by (1) reversing scores for all items except the seven items in the Life Outlook subscale; (2) transforming all item scores to a 0-100 point scale (1=0; 2=25; 3=50; 4=75; 5=100); and (3) summing item scores and dividing by the item count to generate subscale and total scores. The scoring algorithm indicates that the total score can be computed with up to three missing items, and each subscale score can be computed with up to one missing item.


  6. Change (Study Day 1 to Study Day 42) in TOVA metrics other than ACS, Ex-Gaussian Tau Total [ Time Frame: Study Day 1 to Study Day 42 ]

    To evaluate changes in the following additional Test of Variables of Attention (TOVA) metrics other than Attention Comparison Score (ACS) - Ex-Gaussian Tau.

    TOVA is a comparison of a subject's scores based on selected measures that persons with an independent diagnosis of ADHD frequently demonstrated.

    TOVA metric evaluated for change is:

    Ex-Gaussian Tau: The exponential decay (or "right hand tail") of the correct response times, modeled using the Ex-Gaussian distribution. Total refers to entire test (both H1 and H2). H1 refers to the first half of the test where target stimulus is infrequent (1 target to 3.5 non-targets), and H2 represents the second half where target stimulus is frequent (3.5 targets to 1 non-target).

    Measures at Day 1 and Exit/Post-Treatment Visit Day 42.


  7. Change (Study Day 1 to Study Day 42) in TOVA metrics other than ACS, Commission Errors Standard Score H2 [ Time Frame: Study Day 1 to Study Day 42 ]

    To evaluate changes in the following additional Test of Variables of Attention (TOVA) metrics other than Attention Comparison Score (ACS) - Commission Errors Standard.

    TOVA is a comparison of a subject's scores based on selected measures that persons with an independent diagnosis of ADHD frequently demonstrated.

    TOVA metric evaluated for change is:

    Commission Errors Standard Score H2: Commission errors are the number of times the patient clicked the microswitch at the incorrect time. H2 represents the second half where target stimulus is frequent (3.5 targets to 1 non-target).

    Measures at Day 1 and Exit/Post-Treatment Visit Day 42.


  8. Change (Study Day 1 to Study Day 42) in TOVA metrics other than ACS, Response Time Variability Standard Score Total [ Time Frame: Study Day 1 to Study Day 42 ]

    To evaluate changes in the following additional Test of Variables of Attention (TOVA) metrics other than Attention Comparison Score (ACS) - Response Time Variability Standard Score Total.

    TOVA is a comparison of a subject's scores based on selected measures that persons with an independent diagnosis of ADHD frequently demonstrated.

    TOVA metric evaluated for change is:

    Response Time Variability Standard Score Total: The standard score for the first standard deviation of the correct response times. Total refers to entire test (both H1 and H2). H1 refers to the first half of the test where target stimulus is infrequent (1 target to 3.5 non-targets), and H2 represents the second half where target stimulus is frequent (3.5 targets to 1 non-target).

    Measures at Day 1 and Exit/Post-Treatment Visit Day 42.


  9. Change (Study Day 1 to Study Day 42) in TOVA metrics other than ACS, Response Time Mean Standard Score H1 [ Time Frame: Study Day 1 to Study Day 42 ]

    To evaluate changes in the following additional Test of Variables of Attention (TOVA) metrics other than Attention Comparison Score (ACS) - Response Time Mean Standard Score H1.

    TOVA is a comparison of a subject's scores based on selected measures that persons with an independent diagnosis of ADHD frequently demonstrated.

    TOVA metric evaluated for change is:

    Response Time Mean Standard Score H1:The standard score for the mean response time of the correct responses. H1 refers to the first half of the test where target stimulus is infrequent (1 target to 3.5 non-targets).

    Measures at Day 1 and Exit/Post-Treatment Visit Day 42.


  10. Change (Study Day 1 to Study Day 42) in TOVA metrics other than ACS, D-Prime Standard Score H2 [ Time Frame: Study Day 1 to Study Day 42 ]

    To evaluate changes in the following additional Test of Variables of Attention (TOVA) metrics other than Attention Comparison Score (ACS) - D-Prime Standard Score H2.

    TOVA is a comparison of a subject's scores based on selected measures that persons with an independent diagnosis of ADHD frequently demonstrated.

    TOVA metric evaluated for change is:

    D-Prime Standard Score H2: D-Prime score is a response discriminability score reflecting the ratio of hits to false alarms. The measure is derived from Signal Detection Theory and has been shown to help distinguish non-impaired individuals from those diagnosed with attention disorders. The score reflects the accuracy of target (signal) and nontarget (noise) discrimination and can be interpreted as a measure of perceptual sensitivity. H2 represents the second half where target stimulus is frequent (3.5 targets to 1 non-target).

    Measures at Day 1 and Exit/Post-Treatment Visit Day 42.


  11. Change (Study Day 1 to Study Day 42) in TOVA metrics other than ACS, Omission Errors Standard Score H2 [ Time Frame: Study Day 1 to Study Day 42 ]

    To evaluate changes in the following additional Test of Variables of Attention (TOVA) metrics other than Attention Comparison Score (ACS) - Omission Errors Standard Score H2.

    TOVA is a comparison of a subject's scores based on selected measures that persons with an independent diagnosis of ADHD frequently demonstrated.

    TOVA metric evaluated for change is:

    Omission Errors Standard Score H2: Omission Errors are the number of times the patient failed to click the microswitch when the target was presented. H2 represents the second half where target stimulus is frequent (3.5 targets to 1 non-target).

    Measures at Day 1 and Exit/Post-Treatment Visit Day 42.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adults 18 years and older
  2. 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
  3. Stably on or off ADHD medications for ≥4 weeks prior to study enrollment and throughout the primary 6-week study
  4. Stably on or off psychoactive medications for ≥4 weeks prior to study enrollment and throughout the 6-week study
  5. Baseline visit score on the ADHD-RS-IV of ≥ 24
  6. Baseline visit score on the TOVA-ACS score ≤ -1.8
  7. Estimated IQ score ≥80 as assessed by the Kaufmann Brief Intelligence Test, Second Edition (KBIT-II)
  8. Access to and self-report of ability to connect wireless devices to a functional wireless network
  9. Ability to follow written and verbal instructions (English) as assessed by the PI and/or study coordinator
  10. Able to comply with all testing and study requirements
  11. Completion of informed consent form

Exclusion Criteria:

  1. Current controlled or uncontrolled, comorbid psychiatric diagnosis with significant symptoms that in the opinion of the Investigator may confound study data/assessments.
  2. Suicidality assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS)
  3. Motor condition (e.g., physical deformity of the hands/arms) that prevents game playing as reported by the participant or observed by the Investigator.
  4. History of moderate or severe substance use disorder within the last 12 months prior to informed consent
  5. History of seizures (excluding febrile seizures), significant tics, or a current diagnosis of Tourette's Disorder.
  6. Known sensitivity to playing video games, such as photo-sensitive epilepsy, light-headedness, dizziness, nausea, or motion sickness.
  7. Color blindness as detected by Ishihara Color Blindness Test
  8. Positive urine drug screen
  9. 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
  10. Any other medical condition that in the opinion of the Investigator may confound study data/assessments.
  11. Participation in a clinical trial within 3 months prior to screening.
  12. Previous exposure to Akili products within the 6 months prior to study enrollment
  13. 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.
  14. Planned initiation of, or significant changes in frequency, of non-pharmacological behavioral therapy during the primary study
  15. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05183919


Contacts
Layout table for location contacts
Contact: Tracy Hofmann 984-389-1932 tracy.hofmann@aperioclinical.com
Contact: Minny Suh minny@akiliinteractive.com

Locations
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United States, Arizona
Melmed Center Recruiting
Scottsdale, Arizona, United States, 85254
Contact: Raun Melmed, MD         
United States, California
CNS Clinical Research Trials Recruiting
Garden Grove, California, United States, 92845
Contact: David Walling, MD         
United States, Florida
Innovative Clinical Research, Inc. Recruiting
Lauderhill, Florida, United States, 33319
Contact: Kadian Watson         
Principal Investigator: Rishi Kakar, MD         
Accel Research Sites Recruiting
Maitland, Florida, United States, 32751
Contact: Andrea Marraffino, PhD         
Behavioral Clinical Research, Inc. Recruiting
Miami Lakes, Florida, United States, 33016
Contact: Jessmin Richani         
Principal Investigator: Olga Lapeyra, MD         
United States, Missouri
Midwest Research Group Recruiting
Saint Charles, Missouri, United States, 63304
Contact: Mattingly Greg, MD         
United States, Nebraska
Alivation Research Recruiting
Lincoln, Nebraska, United States, 68526
Contact: Walter Duffy, MD         
United States, Nevada
Center for Psychiatry and Behavioral Medicine, Inc. Recruiting
Las Vegas, Nevada, United States, 89128
Contact: Ann Childress, MD         
United States, New Jersey
Hassman Research Institute Recruiting
Berlin, New Jersey, United States, 08009
Contact: Cassie Blanchard, MD         
United States, New Mexico
Albuquerque Neuroscience, Inc. Recruiting
Albuquerque, New Mexico, United States, 87109
Contact: Laura Allen, MD         
United States, North Carolina
MindPath Care Centers Recruiting
Raleigh, North Carolina, United States, 27606
Contact: Sandeep Vaishnavi, DM, PHD         
United States, Oklahoma
IPS Research Recruiting
Oklahoma City, Oklahoma, United States, 73106
Contact: Louise Thurman, MD         
United States, Texas
FutureSearch Trials Recruiting
Dallas, Texas, United States, 75231
Contact: Downing Michael, MD         
Southeast Houston Research, Inc. Recruiting
Houston, Texas, United States, 77089
Contact: Napoleon Higgins, MD         
Sponsors and Collaborators
Akili Interactive Labs, Inc.
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Responsible Party: Akili Interactive Labs, Inc.
ClinicalTrials.gov Identifier: NCT05183919    
Other Study ID Numbers: Akili-057
First Posted: January 11, 2022    Key Record Dates
Last Update Posted: August 18, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Akili Interactive Labs, Inc.:
ADHD
Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders