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Behavioural Intervention

AKL-T01 for Attention Deficit Hyperactivity Disorder (ADHD)

N/A
Waitlist Available
Research Sponsored by Akili Interactive Labs, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after 4 weeks of treatment with akl-t01
Awards & highlights

Study Summary

This trial will test whether digital therapy can improve symptoms and attention in adolescents with ADHD.

Eligible Conditions
  • Attention Deficit Hyperactivity Disorder (ADHD)

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after 4 weeks of treatment with akl-t01
This trial's timeline: 3 weeks for screening, Varies for treatment, and after 4 weeks of treatment with akl-t01 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
Secondary outcome measures
Secondary objective of this study is to evaluate the change in ADHD symptoms
Other outcome measures
To evaluate changes in TOVA metrics other than ACS - Commission Errors Standard Score H2
To evaluate changes in TOVA metrics other than ACS - D-Prime Standard Score H2
To evaluate changes in TOVA metrics other than ACS - Ex-Gaussian Tau Total
+7 more

Side effects data

From 2023 Phase 2 trial • 110 Patients • NCT04843930
4%
Dizziness
2%
Headache
2%
Planned surgery
2%
Nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
AKL-T01 Intervention
Waitlist Control
Control Arm Participants Who Started AKL-T01 Intervention
Control Arm Participants Who Declined AKL-T01 Intervention

Trial Design

1Treatment groups
Experimental Treatment
Group I: AKL-T01Experimental Treatment1 Intervention
Digital Treatment
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AKL-T01
2018
Completed Phase 2
~860

Find a Location

Who is running the clinical trial?

Akili Interactive Labs, Inc.Lead Sponsor
15 Previous Clinical Trials
5,000 Total Patients Enrolled
8 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
4,564 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Other
North Carolina
British Columbia
California
How old are they?
18 - 65
What site did they apply to?
MindPath Care Centers
MTP Psychiatry
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. MindPath Care Centers: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Software Treatment for Actively Reducing Severity of ADHD in Adolescents (STARS-ADHD-Adolescents)
2021. "Software Treatment for Actively Reducing Severity of ADHD in Adolescents (STARS-ADHD-Adolescents)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04897074.
~44 spots leftby Apr 2025
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