Clinical trial NCT05183919: Software Treatment for Actively Reducing Severity of ADHD in Adults (STARS ADHD Adult)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD
Lead sponsor: Akili Interactive Labs, Inc.
Sponsor class: INDUSTRY
First posted: 2022-01-11
Enrollment: 223
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
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
timeFrame: Study Day 1 to Study Day 42
Secondary outcomes:
measure: 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
timeFrame: Study Day 1 to Study Day 42
Other outcomes:
measure: Change (Study Day 1 to Study Day 42) in Adult ADHD Quality of Life Questionnaire (AAQoL) total score
timeFrame: Study Day 1 to Study Day 42
measure: Change (Study Day 1 to Study Day 42) in the Adult ADHD Quality of Life Questionnaire (AAQoL) Adult, subscale score for Life Productivity subscale
timeFrame: Study Day 1 to Study Day 42
measure: Change (Study Day 1 to Study Day 42) in the Conners' Adult ADHD Rating Scales-Self Report: Short Version (CAARS-S:S) score
timeFrame: Study Day 1 to Study Day 42
measure: Proportion of responders at end of treatment defined as 30% reduction in total ADHD-Rating Scale-IV score
timeFrame: Study Day 1 to Study Day 42
measure: Proportion of responders at end of treatment defined as 8-point change in Adult ADHD Quality of Life Questionnaire (AAQoL)
timeFrame: Study Day 1 to Study Day 42
measure: Change (Study Day 1 to Study Day 42) in TOVA metrics other than ACS, Ex-Gaussian Tau Total
timeFrame: Study Day 1 to Study Day 42
measure: Change (Study Day 1 to Study Day 42) in TOVA metrics other than ACS, Commission Errors Standard Score H2
timeFrame: Study Day 1 to Study Day 42
measure: Change (Study Day 1 to Study Day 42) in TOVA metrics other than ACS, Response Time Variability Standard Score Total
timeFrame: Study Day 1 to Study Day 42
measure: Change (Study Day 1 to Study Day 42) in TOVA metrics other than ACS, Response Time Mean Standard Score H1
timeFrame: Study Day 1 to Study Day 42
measure: Change (Study Day 1 to Study Day 42) in TOVA metrics other than ACS, D-Prime Standard Score H2
timeFrame: Study Day 1 to Study Day 42
measure: Change (Study Day 1 to Study Day 42) in TOVA metrics other than ACS, Omission Errors Standard Score H2
timeFrame: Study Day 1 to Study Day 42
Locations:
city: Scottsdale
country: United States
facility: Melmed Center
state: Arizona
city: Garden Grove
country: United States
facility: CNS Clinical Research Trials
state: California
city: Lauderhill
country: United States
facility: Innovative Clinical Research, Inc.
state: Florida
city: Maitland
country: United States
facility: Accel Research Sites
state: Florida
city: Miami Lakes
country: United States
facility: Behavioral Clinical Research, Inc.
state: Florida
city: Saint Charles
country: United States
facility: Midwest Research Group
state: Missouri
city: Lincoln
country: United States
facility: Alivation Research
state: Nebraska
city: Las Vegas
country: United States
facility: Center for Psychiatry and Behavioral Medicine, Inc.
state: Nevada
city: Berlin
country: United States
facility: Hassman Research Institute
state: New Jersey
city: Albuquerque
country: United States
facility: Albuquerque Neuroscience, Inc.
state: New Mexico
city: Raleigh
country: United States
facility: MindPath Care Centers
state: North Carolina
city: Oklahoma City
country: United States
facility: IPS Research
state: Oklahoma
city: Dallas
country: United States
facility: FutureSearch Trials
state: Texas
city: Houston
country: United States
facility: Southeast Houston Research, Inc.
state: Texas
Study officials:
References: