MedTrace Logo

EndeavorOTC® Research Study in College Students

NCT06376032 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2024-06-27

No results posted yet for this study

Summary

The objective of this study is to evaluate the impact of a digital therapeutic (EndeavorOTC®, also known as AKL-T01A) on clinical symptoms of executive and cognitive functioning in a real-world sample of university students. This study aims to answer whether EndeavorOTC represents a useful intervention for targeting broad cognitive and emotional health among university students.

Conditions

  • Attention
  • Cognition
  • University Students

Interventions

DEVICE

EndeavorOTC®

EndeavorOTC is an over the counter digital therapeutic designed to improve attention function as measured by computer-based testing in patients 18 and older with primarily inattentive or combined type ADHD, who have a demonstrated attention issue. EndeavorOTC utilizes the same proprietary technology underlying EndeavorRx®, an FDA-authorized prescription digital therapeutic indicated to improve attention function in children ages 8-17. 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

  • Landmark College

    collaborator UNKNOWN

  • Villa Maria College

    collaborator UNKNOWN

  • Akili Interactive Labs, Inc.

    lead INDUSTRY

Principal Investigators

  • Caitlin Stamatis, PhD · Akili Interactive Labs, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-10
Primary Completion
2025-12-31
Completion
2025-12-31
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 NCT06376032 on ClinicalTrials.gov