Recruiting

Lifestyle Interventions

Sponsor:

Indiana University

Code:

NCT05573490

Conditions

Alzheimer Disease, Early Onset

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Cognitive Training

Tai Chi- Qi Gong

Brain Games

Stretching

Study Details

Brief summary:

The purpose of this study is to generate preliminary data on the benefit of computerized cognitive training and Tai Chi- Qi Gong training in participants with Early-Onset Alzheimer's Disease. It is hypothesized that participants in the experimental training condition will perform better on outcomes related to cognition, functioning, and mood at follow-up compared to participants assigned to the active control condition.

Conditions

Alzheimer Disease, Early Onset

Study ID

NCT05573490

Start date

Jan 11, 2024

Status verified date

May, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Enrolled in the Longitudinal Early-Onset AD Study (LEADS) parent study, and being classified via LEADS consensus criteria as having amyloid-positive Early Onset Alzheimer's Disease
  • Aged 40-64 years at the time of enrollment into LEADS
  • Fluent in English
  • In good general health and absent another neurological disorder
  • Have a knowledgeable informant.
  • Have had a Clinical Dementia Rating scale of 0.5 to 1.0 at the time of enrollment into LEADS
  • Have sufficient vision, hearing, comprehension, and manual dexterity to participate in the testing and training program

Exclusion Criteria:

• Have access to the internet (e.g., home, family, public library, etc.) for less than 4 hours per week

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Experimental Cognitive Training and Tai Chi- Qi Gong Arm

Participants receiving 14 weeks of Cognitive Training (BrainHQ) and Tai Chi- Qi Gong exercise training

active comparator: Active Control Arm

Participants receiving 14 weeks of Brain Games (BrainHQ) and stretching

Interventions

Cognitive Training

Participants will be asked to complete approximately 45 minutes of training, 4-5 sessions per week for 14 weeks (corresponding to approximately 40 hours of training total). Training will be completed via BrainHQ, a mobile application that, as used in this study, meets the FDA's definition of a medical device.

Tai Chi- Qi Gong

Participants will be asked to complete 14 hours of training total (in 30-minute sessions, 2 days per week for 14 weeks).

Brain Games

Participants will be asked to complete 40 hours of training total (in 45-minute sessions, 4 to 5 days per week for 14 weeks). Training will be completed via BrainHQ, a mobile application that, as used in this study, meets the FDA's definition of a medical device.

Stretching

Participants will be asked to engage in stretching exercises twice per week, for approximately 20-30 minutes per session. This will total 14 hours over the course of 14 weeks.

Primary outcome measure

  • Performance on CANTAB Connect computerized Memory Composite immediately post-intervention, after controlling for baseline performance [ Time Frame: 15-Week Post-Intervention Follow-up ]
  • Performance on CANTAB Connect computerized Executive Composite immediately post-intervention, after controlling for baseline performance [ Time Frame: 15-Week Post-Intervention Follow-up ]
  • Performance on CANTAB Connect computerized Memory Composite 26 weeks after intervention, after controlling for baseline performance [ Time Frame: 40-Week Post-Intervention Follow-up ]
  • Performance on CANTAB Connect computerized Executive Composite 26 weeks after intervention, after controlling for baseline performance [ Time Frame: 40-Week Post-Intervention Follow-up ]

Central Contacts and Locations

Central contacts

Dustin B Hammers, PhD

3179638557hammersd@iu.edu

Locations

Indiana University

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Dustin B Hammers, PhD

3179638557hammersd@iu.edu

Principal Investigator:

Dustin B Hammers, PhD

More Information

Sponsor

Indiana University

Last update posted

May 6, 2026

Last verified

May, 2026

Keywords

  • lifestyle intervention
  • cognitive training
  • exercise training
  • cognition

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Indiana University on 2026-05-06.