NCT05573490 · Indiana University
Lifestyle Interventions for the Treatment of Early Onset Alzheimer's Disease Study
(LITES)
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
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.
BEHAVIORAL
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).
DEVICE
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.
BEHAVIORAL
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 measures
Performance on CANTAB Connect computerized Memory Composite immediately post-intervention, after controlling for baseline performance
Time frame: 15-Week Post-Intervention Follow-up
CANTAB Connect computerized Memory Composite was selected for its remote assessment of memory, with validation in Alzheimer's Disease samples. This composite will be calculated from Paired Associates Learning, Pattern Recognition Memory, and Verbal Paired Associates subtests, with higher scores reflected better performance.
Performance on CANTAB Connect computerized Executive Composite immediately post-intervention, after controlling for baseline performance
Time frame: 15-Week Post-Intervention Follow-up
CANTAB Connect computerized Executive Composite was selected for its remote assessment of executive functioning, with validation in Alzheimer's Disease samples. This composite will be calculated from Stockings of Cambridge, Spatial Working Memory, Rapid Visual Processing, and Match To Sample subtests, with higher scores reflected better performance.
Performance on CANTAB Connect computerized Memory Composite 26 weeks after intervention, after controlling for baseline performance
Time frame: 40-Week Post-Intervention Follow-up
CANTAB Connect computerized Memory Composite was selected for its remote assessment of memory, with validation in Alzheimer's Disease samples. This composite will be calculated from Paired Associates Learning, Pattern Recognition Memory, and Verbal Paired Associates subtests, with higher scores reflected better performance.
Performance on CANTAB Connect computerized Executive Composite 26 weeks after intervention, after controlling for baseline performance
Time frame: 40-Week Post-Intervention Follow-up
CANTAB Connect computerized Executive Composite was selected for its remote assessment of executive functioning, with validation in Alzheimer's Disease samples. This composite will be calculated from Stockings of Cambridge, Spatial Working Memory, Rapid Visual Processing, and Match To Sample subtests, with higher scores reflected better performance.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Indianapolis, Indiana
Collaborators
Alzheimer's Association, Tai Chi Foundation, Alzheimer's Therapeutic Research Institute, National Institute on Aging (NIA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 6, 2026 · Source of record for eligibility and locations