Ignite Creation Date:
2024-05-06 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 12:52 PM
Study NCT ID:
NCT03649074
Status:
COMPLETED
Last Update Posted:
2023-08-09
First Post:
2018-08-23
Brief Title:
Software Treatment for Actively Reducing Severity of ADHD as Adjunctive Treatment to Stimulant
Sponsor:
Akili Interactive Labs Inc
Organization:
Akili Interactive Labs Inc
Study Overview
Official Title:
Software Treatment for Actively Reducing Severity of ADHD as Adjunctive Treatment to Stimulant STARS-ADHD Adjunctive
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 childs 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 childs 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 childs 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
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 childs 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 childs 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 childs 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None