Ignite Creation Date:
2024-05-06 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 2:21 PM
Study NCT ID:
NCT05183919
Status:
COMPLETED
Last Update Posted:
2023-02-28
First Post:
2021-12-02
Brief Title:
Software Treatment for Actively Reducing Severity of ADHD in Adults STARS ADHD Adult
Sponsor:
Akili Interactive Labs Inc
Organization:
Akili Interactive Labs Inc
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-02
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 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 unblindednon-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 Screeningbaseline 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 treatmentuse requirements will be monitored remotely during this phase
An In-Clinic assessment will be completed on Day 42 to assess key outcomes
A maximum of 325 total participants from 12-30 sites will be enrolled
During the Screeningbaseline 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 treatmentuse requirements will be monitored remotely during this phase
An In-Clinic assessment will be completed on Day 42 to assess key outcomes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None