Attention Deficit Hyperactivity DisorderNCT03649074
Software Treatment for Actively Reducing Severity of ADHD as Adjunctive Treatment to Stimulant
A study testing AKL-T01 in people with Attention Deficit Hyperactivity Disorder, run by Akili Interactive Labs, Inc. at 2 sites in United States.
Trial summary
The purpose of this study is to determine the effects of combining AKL-T01 (with AKL-X01 symptom tracking) as adjunctive treatment to stimulant medication, and to understand the effects of AKL-T01 treatment (with AKL-X01 symptom tracking) in participants not recently on medication. Read more about this study
- Who is it for?
- Ages 8 to 14 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- AKL-T01
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Dec 2018to 23 Sep 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 8 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female, ages 8 years 0 months to 14 years 9 months (inclusive), at the time of parental informed consent.
- Confirmed ADHD diagnosis (primarily inattentive or combined subtype), at Screening based on DSM-V criteria and established via the MINI-KID administered by a trained clinician.
- Note: Co-morbid diagnoses on the MINI-KID are acceptable provided that ADHD is the primary diagnosis and the co-morbid diagnoses will not confound study data (per the Investigator's judgment).
- Currently experiencing sub-optimal treatment of ADHD, based upon results of Clinical Global Impression-Severity score.
- Impairment Rating Scale (Parent Report) score of ≥ 3 at Screening.
- Ability to follow written and verbal instructions (English), as assessed by the PI and/or study coordinator.
Show all 17Show fewer
- Estimated IQ score > 80 as assessed by the Kaufmann Brief Intelligence Test, Second Edition (KBIT-II).
- Ability to comply with all testing, requirements, study procedures, and availability for the duration of the study.
- Provision of signed and dated parental informed consent form and assent form.
- Participant's parent and/or caregiver has access any of the following Apple™ or Android™ smart phone and/or mobile devices (for accessing AKL-X01 application): Apple iPhone 6, 6+, 7, 8, 10; Android Samsung Galaxy S7, S7 Edge, S8, S8+, S9, S9+; Android Samsung Note 8; Android LG G6, G7, V30, K20. Apple mobile devices must be running iOS 11.2+. Android mobile devices must be running Nougat or Marshmallow.
- For Cohort 1 (stimulant), participant must be stable** on stimulant medication, at an approved FDA dose , for ≥ 30 days prior to enrollment (may also be one stimulant plus a booster, provided that the dose is stable and does not change throughout the course of the trial).
- Note: Medication stability is defined as:
- Moderate response on stimulant, but still room for improvement
- Dose unchanged within past 30 days, but other doses have been tried previously without improvement
- Currently taking stimulant, but parent and/or caregiver wishes not to increase dosage for any reason
- Taking consistent stimulant dose on weekdays, but not on weekends
- For Cohort 2 (non-stimulant), participant must be stable off stimulant medication for ≥ 30 days prior to enrollment.
Who cannot join
- Current, controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis , based on MINI-KID and subsequent clinical interviewing, with significant symptoms including but not limited to:
- post-traumatic stress disorder
- psychosis
- bipolar illness
- pervasive developmental disorder
- severe obsessive compulsive disorder
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- severe depressive
- severe anxiety disorder
- conduct disorder
- other symptomatic manifestations that in the opinion of the Investigator may confound study data/assessments.
- Participants with clinical history of learning disorders will be allowed to participate, provided the disorder does not impact their ability to participate in the trial based on PI judgment.
- Participants who are currently treated with a non-stimulant medication for ADHD (i.e., atomoxetine, clonidine, guanfacine).
- Participants diagnosed with ADHD Hyperactive-Impulsive subtype, based upon score on the MINI-KID interview.
- Participants showing no room for improvement, or those refractory to non-intensive ADHD treatment.
- Initiation within the last 4 weeks from the time of consent of behavioral therapy. Participants who have been in behavior therapy consistently for more than 4 weeks may participate provided their therapy frequency and intensity is unchanged during the course of the study. Participants planning on changing or initiating behavior therapy during the course of the study will be excluded.
- Participant is currently considered a suicide risk in the opinion of the Investigator, has previously made a suicide attempt, or has a prior history of, or is currently demonstrating active suicidal ideation or self-injurious behavior as measured by C-SSRS at Screening.
- Motor condition (e.g., physical deformity of the hands/arms; prostheses) that prevents playing the digital treatment as reported by the parent or observed by the investigator.
- Recent history (within the past 6 months) of suspected substance abuse or dependence
- History of seizures (exclusive of febrile seizures), or significant motor or vocal tics, including but not limited to Tourette's Disorder)
- Has participated in a clinical trial within 90 days prior to Screening.
- Diagnosis of or parent-reported color blindness (Confirmed in-clinic via ICBT)
- Uncorrected visual acuity (confirmed in-clinic, via ability of participant to play the game, at Screening)
- Regular use of psychoactive drugs (non-stimulant) that in the opinion of the Investigator may confound study data/assessments.
- Any other medical, behavioral, or developmental condition that in the opinion of the investigator may confound study data/assessments.
- Has a sibling also enrolled/currently participating in the same study. Siblings may participate in the study sequentially, but not at the same time.
- Has previously been randomized in a study of Akili's videogame-like digital treatment.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Center for Psychiatry and Behavioral Medicine
Las Vegas, Nevada, 89128
Melmed Center
Scottsdale, Arizona, 85254
About this study
Official title: Software Treatment for Actively Reducing Severity of ADHD as Adjunctive Treatment to Stimulant (STARS-ADHD Adjunctive)
The purpose of this study is to determine the effects of combining AKL-T01 (with AKL-X01 symptom tracking) as adjunctive treatment to stimulant medication, and to understand the effects of AKL-T01 treatment (with AKL-X01 symptom tracking) in participants not recently on medication.
Read the detailed description
The study aims to enroll (203) participants, with a confirmed diagnoses of ADHD, at approximately 15 sites and will be divided between 2 cohorts; 130 participants will be enrolled in Cohort 1, and 73 participants will be enrolled in Cohort 2.
Cohort 1 will have been stable (adherence to a prescribed medication schedule) on a stimulant medication, but are inadequately managed by the stimulant (in the opinion of the investigator). The stimulant is managed by their own physician for at least 30 days before baseline. This is the Stimulant cohort.
Cohort 2 will have been stable without any stimulant medication for at least 30 days before the baseline. This is the Non-Stimulant cohort.
For both cohorts, at least 7 and up to 30 days before baseline, participants' caretakers will begin using AKL-X01 (Fengo) to track their participants' symptoms and behaviors.
During Treatment Phase 1 (Days 1 through 28) participants in Cohort 1 (Stimulant) will continue to receive their current stimulant plus the addition of AKL-T01. Participants in Cohort 2 (Non-Stimulant) will just receive AKL-T01. For both cohorts, during this time the caretakers will monitor their child's symptoms daily with AKL-X01.
During the 1-Month Break (Days 29 through 56) between AKL-T01 treatment phases, participants in Cohort 1 will continue to receive their current stimulant. In both cohorts, AKL-T01 will be suspended during this time. For both cohorts, during this time caretakers will continue to monitor their child's symptoms daily with AKL-X01.
During Treatment Phase 2 (Days 57 through 84), participants in Cohort 1 (stimulant) will continue to receive their current stimulant plus the addition of AKL-T01. Participants in Cohort 2 will just receive AKL-T01. For both cohorts, during this time the caretakers will monitor their child's symptoms daily with AKL-X01.
AKL-T01, or EVO Multi, is a digital intervention that requires the subject to navigate a character through a game-like space, while collecting objects, in a fixed period of time.
AKL-T01: Videogame-like digital therapy
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- AKL-T01
- 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.
AKL-T01Device
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 | AKL-T01 digital treatment. Receives: Device: AKL-T01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impairment Rating Scale, Overall Impairment (Change From Baseline to Posttreatment) in Cohort 1: Stimulant
The Impairment Rating Scale (IRS) is a parent-rated scale that assesses individualized areas of impairment for a child participant and asks parents to make a rating of how significantly these problems impact functioning across a range of domains (social, family, school, self-esteem). Parents describe the primary areas of difficulty for each child and then provide a rating (via a Visual Analog Scale) of how much the difficulties affect the different areas of functioning ranging from (1) "no problem; definitely does not need treatment or special services" to (7) "extreme problem; definitely needs treatment or special services." The total IRS is 8 items, the 8th rating overall impairment. A negative change indicated a decrease in overall impairment.
Measured: Day 0 to Day 28
Impairment Rating Scale, Overall Impairment (Change From Baseline to Posttreatment) in Cohort 2: Non-Stimulant
The Impairment Rating Scale (IRS) is a parent-rated scale that assesses individualized areas of impairment for a child participant and asks parents to make a rating of how significantly these problems impact functioning across a range of domains (social, family, school, self-esteem). Parents describe the primary areas of difficulty for each child and then provide a rating (via a Visual Analog Scale) of how much the difficulties affect the different areas of functioning ranging from (1) "no problem; definitely does not need treatment or special services" to (7) "extreme problem; definitely needs treatment or special services." The total IRS is 8 items, the 8th rating overall impairment. A negative change indicated a decrease in overall impairment.
Measured: Day 0 to Day 28
Secondary outcomes (6)
ADHD-RS Total (Change From Baseline to Posttreatment) - Cohort 1: Stimulant
The ADHD-RS-IV is an 18-item, clinician-administered questionnaire for which a parent respondent rates the frequency of occurrence of ADHD symptoms and behaviors as defined by criteria outlined for ADHD in the DSM-IV. Each item is scored on a 4-point scale ranging from 0 (rarely or never) to 3 (very often) with total scores ranging from 0-54. A higher score indicates more severe ADHD symptoms and behaviors. A negative change in total score indicates improvement from Day 0 to Day 28.
Measured: Day 0 to Day 28
ADHD-RS Total (Change From Baseline to Posttreatment) - Cohort 2: Non-Stimulant
The ADHD-RS-IV is an 18-item, clinician-administered questionnaire for which a parent respondent rates the frequency of occurrence of ADHD symptoms and behaviors as defined by criteria outlined for ADHD in the DSM-IV. Each item is scored on a 4-point scale ranging from 0 (rarely or never) to 3 (very often) with total scores ranging from 0-54. A higher score indicates more severe ADHD symptoms and behaviors. A negative change in total score indicates improvement from Day 0 to Day 28.
Measured: Day 0 to Day 28
CGI-I (at Posttreatment) - Cohort 1: Stimulant
The Clinical Global Impression Scale - Improvement (CGI-I) is a clinician's comparison of the participant's overall clinical condition at follow up to the overall clinical condition at baseline. The CGI-S is a 7-point scale where 1 = Very much improved, 2=Much improved, 3=Minimally improved, 4=No change, 5=Minimally worse, 6=Much worse, and 7=Very much worse.
A score of 1, 2, or 3 would indicate overall improvement of ADHD severity.
Measured: Day 28
CGI-I (at Posttreatment) - Cohort 2: Non-Stimulant
The Clinical Global Impression Scale - Improvement (CGI-I) is a clinician's comparison of the participant's overall clinical condition at follow up to the overall clinical condition at baseline. The CGI-S is a 7-point scale where 1 = Very much improved, 2=Much improved, 3=Minimally improved, 4=No change, 5=Minimally worse, 6=Much worse, and 7=Very much worse.
A score of 1, 2, or 3 would indicate overall improvement of ADHD severity.
Measured: Day 28
Change TOVA Attention Composite Score (ACS) - Cohort 1: Stimulant
TOVA ACS is a comparison of the subject's scores based on selected measures that persons with an independent diagnosis of ADHD frequently demonstrated. ACS is calculated from variability, response time (RT), and d' Prime using the following formula: ACS = RT Z score (Half 1) + D' Z score (Half 2) + variability Z score (Total) + 1.80 where RT 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. ACS tells how similar the score is to the ADHD profile. A score of less than -1.8 indicates that the subject had similar performance to a normative ADHD population. A lower score indicates a more severe ADHD profile. The calculation for difference in TOVA ACS is ACS at Baseline (Day 0) minus ACS at Day 28.
Measured: Day 0 to Day 28
Change TOVA Attention Composite Score (ACS) - Cohort 2: Non-Stimulant
TOVA ACS is a comparison of the subject's scores based on selected measures that persons with an independent diagnosis of ADHD frequently demonstrated. ACS is calculated from variability, response time (RT), and d' Prime using the following formula: ACS = RT Z score (Half 1) + D' Z score (Half 2) + variability Z score (Total) + 1.80 where RT 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. ACS tells how similar the score is to the ADHD profile. A score of less than -1.8 indicates that the subject had similar performance to a normative ADHD population. A lower score indicates a more severe ADHD profile. The calculation for difference in TOVA ACS is ACS at Baseline (Day 0) minus ACS at Day 28.
Measured: Day 0 to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2018
- Study start28 Dec 2018
- Primary completion23 Sep 2019
- Study completion23 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)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
- Model description
- The study will enroll participants into one of two cohorts according to stimulant status. Both cohorts will be assigned to AKL-T01 (with AKL-X01 symptom tracking).
- Masking
- None (open label)
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akili Interactive Labs, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Lazkowitz, MD, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03649074
- Sponsor's protocol ID
- 001S-A
- Status last verified
- Jul 2023
- First submitted
- 23 Aug 2018
- Last updated
- 9 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Flannery 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 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Software Treatment for Actively Reducing Severity of ADHD as Adjunctive Treatment to Stimulant (STARS-ADHD Adjunctive)
- ClinicalTrials.gov ID
- NCT03649074
- Acronym / sponsor ID
- 001S-A
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- ADHD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Akili Interactive Labs, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Dec 2018 (actual)
- Primary completion
- 23 Sep 2019 (actual)
- Study completion
- 23 Sep 2019 (actual)
- First posted
- 28 Aug 2018 (actual)
- Results
- Posted 9 Aug 2023
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 determine the effects of combining AKL-T01 (with AKL-X01 symptom tracking) as adjunctive treatment to stimulant medication, and to understand the effects of AKL-T01 treatment (with AKL-X01 symptom tracking) in participants not recently on medication.
Detailed description
The study aims to enroll (203) participants, with a confirmed diagnoses of ADHD, at approximately 15 sites and will be divided between 2 cohorts; 130 participants will be enrolled in Cohort 1, and 73 participants will be enrolled in Cohort 2.
Cohort 1 will have been stable (adherence to a prescribed medication schedule) on a stimulant medication, but are inadequately managed by the stimulant (in the opinion of the investigator). The stimulant is managed by their own physician for at least 30 days before baseline. This is the Stimulant cohort.
Cohort 2 will have been stable without any stimulant medication for at least 30 days before the baseline. This is the Non-Stimulant cohort.
For both cohorts, at least 7 and up to 30 days before baseline, participants' caretakers will begin using AKL-X01 (Fengo) to track their participants' symptoms and behaviors.
During Treatment Phase 1 (Days 1 through 28) participants in Cohort 1 (Stimulant) will continue to receive their current stimulant plus the addition of AKL-T01. Participants in Cohort 2 (Non-Stimulant) will just receive AKL-T01. For both cohorts, during this time the caretakers will monitor their child's symptoms daily with AKL-X01.
During the 1-Month Break (Days 29 through 56) between AKL-T01 treatment phases, participants in Cohort 1 will continue to receive their current stimulant. In both cohorts, AKL-T01 will be suspended during this time. For both cohorts, during this time caretakers will continue to monitor their child's symptoms daily with AKL-X01.
During Treatment Phase 2 (Days 57 through 84), participants in Cohort 1 (stimulant) will continue to receive their current stimulant plus the addition of AKL-T01. Participants in Cohort 2 will just receive AKL-T01. For both cohorts, during this time the caretakers will monitor their child's symptoms daily with AKL-X01.
AKL-T01, or EVO Multi, is a digital intervention that requires the subject to navigate a character through a game-like space, while collecting objects, in a fixed period of time.
AKL-T01: Videogame-like digital therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study will enroll participants into one of two cohorts according to stimulant status. Both cohorts will be assigned to AKL-T01 (with AKL-X01 symptom tracking).
| Arm | Type | Receives |
|---|---|---|
| AKL-T01 | Experimental | Device: AKL-T01AKL-T01 digital treatment. |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (17 listed)
- Male or female, ages 8 years 0 months to 14 years 9 months (inclusive), at the time of parental informed consent.
- Confirmed ADHD diagnosis (primarily inattentive or combined subtype), at Screening based on DSM-V criteria and established via the MINI-KID administered by a trained clinician.
- Note: Co-morbid diagnoses on the MINI-KID are acceptable provided that ADHD is the primary diagnosis and the co-morbid diagnoses will not confound study data (per the Investigator's judgment).
- Currently experiencing sub-optimal treatment of ADHD, based upon results of Clinical Global Impression-Severity score.
- Impairment Rating Scale (Parent Report) score of ≥ 3 at Screening.
Key exclusion criteria (26 listed)
- Current, controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis , based on MINI-KID and subsequent clinical interviewing, with significant symptoms including but not limited to:
- Participants with clinical history of learning disorders will be allowed to participate, provided the disorder does not impact their ability to participate in the trial based on PI judgment.
- Participants who are currently treated with a non-stimulant medication for ADHD (i.e., atomoxetine, clonidine, guanfacine).
- Participants diagnosed with ADHD Hyperactive-Impulsive subtype, based upon score on the MINI-KID interview.
- Participants showing no room for improvement, or those refractory to non-intensive ADHD treatment.
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 |
|---|---|---|
| AKL-T01AKL-T01 multitasking digital treatment. AKL-T01 multitasking treatment employs perceptual discrimination attention/memory task as well as a continuous motor "driving" task. | Device | AKL-T01 |
Primary outcome
Impairment Rating Scale, Overall Impairment (Change From Baseline to Posttreatment) in Cohort 1: Stimulant
Time frame: Day 0 to Day 28
The Impairment Rating Scale (IRS) is a parent-rated scale that assesses individualized areas of impairment for a child participant and asks parents to make a rating of how significantly these problems impact functioning across a range of domains (social, family, school, self-esteem). Parents describe the primary areas of difficulty for each child and then provide a rating (via a Visual Analog Scale) of how much the difficulties affect the different areas of functioning ranging from (1) "no problem; definitely does not need treatment or special services" to (7) "extreme problem; definitely needs treatment or special services." The total IRS is 8 items, the 8th rating overall impairment. A negative change indicated a decrease in overall impairment.
Impairment Rating Scale, Overall Impairment (Change From Baseline to Posttreatment) in Cohort 2: Non-Stimulant
Time frame: Day 0 to Day 28
The Impairment Rating Scale (IRS) is a parent-rated scale that assesses individualized areas of impairment for a child participant and asks parents to make a rating of how significantly these problems impact functioning across a range of domains (social, family, school, self-esteem). Parents describe the primary areas of difficulty for each child and then provide a rating (via a Visual Analog Scale) of how much the difficulties affect the different areas of functioning ranging from (1) "no problem; definitely does not need treatment or special services" to (7) "extreme problem; definitely needs treatment or special services." The total IRS is 8 items, the 8th rating overall impairment. A negative change indicated a decrease in overall impairment.
6 secondary outcomes
ADHD-RS Total (Change From Baseline to Posttreatment) - Cohort 1: Stimulant
Time frame: Day 0 to Day 28
ADHD-RS Total (Change From Baseline to Posttreatment) - Cohort 2: Non-Stimulant
Time frame: Day 0 to Day 28
CGI-I (at Posttreatment) - Cohort 1: Stimulant
Time frame: Day 28
CGI-I (at Posttreatment) - Cohort 2: Non-Stimulant
Time frame: Day 28
Change TOVA Attention Composite Score (ACS) - Cohort 1: Stimulant
Time frame: Day 0 to Day 28
Change TOVA Attention Composite Score (ACS) - Cohort 2: Non-Stimulant
Time frame: Day 0 to Day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
- Individual participant dataSharing planned: Undecided
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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.
Daniel Lazkowitz, MD, PhD principal investigator
Duke University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AKL-T01 in people with Attention Deficit Hyperactivity Disorder, run by Akili Interactive Labs, Inc. at 2 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 17 inclusion and 26 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 9 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Yes. Results are posted in the registry (first posted 9 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Impairment Rating Scale, Overall Impairment (Change From Baseline to Posttreatment) in Cohort 1: Stimulant (time frame: Day 0 to Day 28). The study lists 2 primary outcomes in all. 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 NCT03649074, which also lists 1 linked publication.
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 9 Aug 2023.