Clinical trial NCT04897074: Software Treatment for Actively Reducing Severity of ADHD in Adolescents (STARS-ADHD-Adolescents)
Official title: A Single Arm Pivotal Trial to Assess the Efficacy of AKL-T01, a Novel Digital Intervention Designed to Improve Attention, in Adolescents, Aged 13-17 Years Old, Diagnosed With Attention Deficit Hyperactive Disorder (ADHD)
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: 2021-05-21
Enrollment: 165
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
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 videogame-like digital therapy on attentional functioning and symptoms in adolescents ages 13-17 diagnosed with ADHD

Detailed description: This study is a multi-center, unblinded/non-controlled study to evaluate objective attention functioning and ADHD symptoms and impairments in adolescents aged 13 to 17 years old, with a diagnosis of ADHD (combined or inattentive subtype), stably on or off ADHD medication, after 4-weeks of AKL-T01 treatment.

Up to 165 total participants from up to 20 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 2-27) 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 28 to assess key outcomes.

Eligibility criteria: Inclusion Criteria:

1. Adolescents between the ages of 13 and 17 years and 10 months at time of consent (must be under 18 years at study completion)
2. Confirmed diagnosis of ADHD combined or inattentive type, according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) as confirmed by MINI-Kid Version 7.0.2.
3. Stably on or off ADHD medication for ≥4 weeks prior to study enrollment and throughout the 4-week study
4. Baseline visit score on the TOVA-ACS score ≤ -1.8
5. Access to and self-report of ability to connect wireless devices to a functional wireless network
6. Ability to follow written and verbal instructions (English) as assessed by the PI and/or study coordinator
7. Able to comply with all testing and study requirements
8. Estimated IQ score ≥80 as assessed by the Kaufmann Brief Intelligence Test, Second Edition (KBIT-II)
9. Patient assent and caregiver informed consent
10. Stably on or off psychoactive medications for ≥4 weeks prior to study enrollment and throughout the 4-week study

Exclusion Criteria:

1. Current controlled or uncontrolled, comorbid psychiatric diagnosis that in the opinion of the Investigator may confound study data/assessments.
2. Participant is currently considered at risk for attempting suicide, has made a suicide attempt within the past year, or is currently demonstrating active suicidal ideation or self-injurious behavior, in the opinion of the Investigator based on the MINI-kid clinical interview.
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. Recent history (6 months prior to screening) of substance use disorder
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. Participation in a clinical trial within 3 months prior to screening.
8. Plans to initiate, or to make significant changes in frequency, of non-pharmacological behavioral therapy during the study
9. Color blindness as detected by Ishihara Color Blindness Test
10. Urine test positive for nicotine or marijuana
11. Any other medical condition that in the opinion of the Investigator may confound study data/assessments.
12. Previous exposure to Akili Products within the 6 months prior to study enrollment
13. Plans to initiate or make significant changes to frequency or duration of non-pharmacological trainings with the aim to improve cognition by means of game or app-based cognitive trainings or neurofeedback, during the study

Primary outcomes:
measure: Primary objective of this study is to evaluate the efficacy of AKL-T01 as determined by the change in a digitally assessed measure after 4 weeks of treatment
timeFrame: After 4 weeks of treatment with AKL-T01
Secondary outcomes:
measure: Secondary objective of this study is to evaluate the change in ADHD symptoms
timeFrame: After 4 weeks of treatment with AKL-T01
Other outcomes:
measure: To evaluate the change in patient and caregiver perceived cognitive deficits
timeFrame: After 4 weeks of treatment with AKL-T01
measure: To evaluate changes in functional impairment
timeFrame: After 4 weeks of treatment with AKL-T01
measure: To evaluate changes in TOVA metrics other than ACS - Ex-Gaussian Tau Total
timeFrame: After 4 weeks of treatment with AKL-T01
measure: To evaluate changes in TOVA metrics other than ACS - Commission Errors Standard Score H2
timeFrame: After 4 weeks of treatment with AKL-T01
measure: To evaluate changes in TOVA metrics other than ACS - Response Time Variability Standard Score Total
timeFrame: After 4 weeks of treatment with AKL-T01
measure: To evaluate changes in TOVA metrics other than ACS - Response Time Mean Standard Score H1
timeFrame: After 4 weeks of treatment with AKL-T01
measure: To evaluate changes in TOVA metrics other than ACS - D-Prime Standard Score H2
timeFrame: After 4 weeks of treatment with AKL-T01
measure: To evaluate changes in TOVA metrics other than ACS - Omission Errors Standard Score H2
timeFrame: After 4 weeks of treatment with AKL-T01
measure: To evaluate response rates for TOVA-ACS
timeFrame: After 4 weeks of treatment with AKL-T01
measure: To evaluate response rates for ADHD Rating Scale-5
timeFrame: After 4 weeks of treatment with AKL-T01
Locations:
city: Scottsdale
country: United States
facility: Melmed Center
state: Arizona
city: San Diego
country: United States
facility: Cortica, Inc.
state: California
city: Maitland
country: United States
facility: Accel Research Sites
state: Florida
city: Baltimore
country: United States
facility: MTP Psychiatry
state: Maryland
city: Saint Charles
country: United States
facility: Midwest Research Group
state: Missouri
city: Lincoln
country: United States
facility: Lincoln Pediatric Group
state: Nebraska
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: Albuquerque
country: United States
facility: Albuquerque Neuroscience, Inc.
state: New Mexico
city: Raleigh
country: United States
facility: MindPath Care Centers
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital
state: Ohio
city: Dayton
country: United States
facility: Dayton Clinical Research
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research
state: Oklahoma
city: Houston
country: United States
facility: Southeast Houston Research, Inc.
state: Texas
Study officials:
References: