MedTrace Logo

EndeavorOTC™ Prospective Product Registry

NCT06109051 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 198

Last updated 2024-06-27

No results posted yet for this study

Summary

The EndeavorOTC product registry aims to collect real world data from EndeavorOTC users. The objectives of this registry are to describe clinical and demographic characteristics, treatment patterns, clinical and quality of life outcomes, and healthcare utilization in EndeavorOTC users in a real-world setting.

Conditions

  • ADHD

Interventions

DEVICE

EndeavorOTC

EndeavorOTC™ is an over-the-counter digital therapeutic designed to improve attention function, ADHD symptoms, and quality of life in users 18 years of age and older with primarily inattentive or combined-type ADHD, who have been identified as having a significant attentional impairment. EndeavorOTC utilizes the same proprietary technology underlying EndeavorRx, a prescription digital therapeutic indicated to improve attention function in children ages 8-12. EndeavorOTC is not intended to be a replacement for any form of ongoing treatment. EndeavorOTC is deployed on mobile devices and incorporates adaptive, simultaneous cognitive tasks in a consumer-grade action videogame-based platform with high-quality graphics and reward mechanisms.

Sponsors & Collaborators

  • Akili Interactive Labs, Inc.

    lead INDUSTRY

Principal Investigators

  • Scott H Kollins, PhD · Akili Interactive Labs, Inc.

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-03
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06109051 on ClinicalTrials.gov