Lifestyle Interventions for the Treatment of Early Onset Alzheimer's Disease Study (LITES)

May 5, 2026 updated by: Dustin Hammers, Indiana University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study aims to generate preliminary data regarding the efficacy of a combined cognitive-training and Tai Chi- Qi Gong exercise lifestyle intervention in participants diagnosed with Early-Onset Alzheimer's Disease (EOAD). Participants will complete a series of cognitive, functional, and mood assessments at a remotely-assessed baseline visit, and then be randomized into one of two conditions: (1) Computerized Cognitive Training + Tai Chi Exercise or (2) Active Control. Outcome measures will be repeated immediately Post-Treatment and at 6-months post-treatment Follow-Up. Specific Aim 1 will examine the feasibility of this lifestyle intervention and outcome assessments when applied to participants with EOAD. Specific Aim 2 will investigate if this lifestyle intervention improves short- and long-term cognition, functioning, and mood. Specific Aim 3 will be exploratory to assess whether individual differences in training or clinical/ demographic characteristics moderate the degree of benefit from this intervention; owing to sample size limitations in this feasibility study, focus of this latter aim will be on determining effect sizes and sample-size magnitude needed for future work.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Dustin B Hammers, PhD
  • Phone Number: 3179638557
  • Email: hammersd@iu.edu

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University
        • Contact:
        • Principal Investigator:
          • Dustin B Hammers, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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.
Other Names:
  • BrainHQ
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).
Active Comparator: Active Control Arm
Participants receiving 14 weeks of Brain Games (BrainHQ) and stretching
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.
Other Names:
  • BrainHQ
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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
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.
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
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.
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
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.
40-Week Post-Intervention Follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Benefit from Cognitive Training using Cognitive Self-Report Questionnaire immediately post-intervention, after controlling for baseline performance
Time Frame: 15-Week Post-Intervention Follow-up
Cognitive Self-Report Questionnaire is a 25-item self-report questionnaire of subjective cognitive difficulties. Scores range from 0-125, with higher scores denoting greater cognitive symptoms. This measure has been used in a variety of studies examining benefit from cognitive training.
15-Week Post-Intervention Follow-up
Benefit from Cognitive Training using Cognitive Self-Report Questionnaire 26 weeks after intervention, after controlling for baseline performance
Time Frame: 40-Week Post-Intervention Follow-up
Cognitive Self-Report Questionnaire is a 25-item self-report questionnaire of subjective cognitive difficulties. Scores range from 0-125, with higher scores denoting greater cognitive symptoms. This measure has been used in a variety of studies examining benefit from cognitive training.
40-Week Post-Intervention Follow-up
Performance on scales of functioning immediately post-intervention, after controlling for baseline performance
Time Frame: 15-Week Post-Intervention Follow-up
The Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory is an informant-based rating scale that assesses the participant's ability to perform a variety of activities of daily living over the past four weeks, and has been shown to discriminate between healthy elderly controls and those with mild Alzheimer's disease. Scores range from 0-78, with higher scores denoting better functional ability.
15-Week Post-Intervention Follow-up
Performance on scales of functioning 26 weeks after intervention, after controlling for baseline performance
Time Frame: 40-Week Post-Intervention Follow-up
The Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory is an informant-based rating scale that assesses the participant's ability to perform a variety of activities of daily living over the past four weeks, and has been shown to discriminate between healthy elderly controls and those with mild Alzheimer's disease. Scores range from 0-78, with higher scores denoting better functional ability.
40-Week Post-Intervention Follow-up
Self-reported depression immediately post-intervention, after controlling for baseline performance
Time Frame: 15-Week Post-Intervention Follow-up
21-item Beck Depression Inventory-2 was used as a measure of self-reported depression. Scores range from 0-63, with higher scores denoting greater self-reported depression symptoms.
15-Week Post-Intervention Follow-up
Self-reported depression 26 weeks after intervention, after controlling for baseline performance
Time Frame: 40-Week Post-Intervention Follow-up
21-item Beck Depression Inventory-2 was used as a measure of self-reported depression. Scores range from 0-63, with higher scores denoting greater self-reported depression symptoms.
40-Week Post-Intervention Follow-up
Self-reported quality of life immediately post-intervention, after controlling for baseline performance
Time Frame: 15-Week Post-Intervention Follow-up
13-item Quality of Life- Alzheimer's Disease scale was used as a measure of self-reported quality of life. Scores range from 13-52, with higher scores denoting greater self-reported quality of life.
15-Week Post-Intervention Follow-up
Self-reported quality of life 26 weeks after intervention, after controlling for baseline performance
Time Frame: 40-Week Post-Intervention Follow-up
13-item Quality of Life- Alzheimer's Disease scale was used as a measure of self-reported quality of life. Scores range from 13-52, with higher scores denoting greater self-reported quality of life.
40-Week Post-Intervention Follow-up
Self-reported stress immediately post-intervention, after controlling for baseline performance
Time Frame: 15-Week Post-Intervention Follow-up
4-item Perceived Stress Scale was used as a measure of self-reported stress. Scores range from 0-16, with higher scores denoting greater stress.
15-Week Post-Intervention Follow-up
Self-reported stress 26 weeks after intervention, after controlling for baseline performance
Time Frame: 40-Week Post-Intervention Follow-up
4-item Perceived Stress Scale was used as a measure of self-reported stress. Scores range from 0-16, with higher scores denoting greater stress.
40-Week Post-Intervention Follow-up
Self-reported perceived social support immediately post-intervention, after controlling for baseline performance
Time Frame: 15-Week Post-Intervention Follow-up
6-Item Multidimensional Scale of Perceived Social Support (MSPSS-6) was used as a measure of self-reported support from family, friends, and a significant other. Scores range from 1-7, with higher scores denoting greater perceived social support.
15-Week Post-Intervention Follow-up
Self-reported perceived social support 26 weeks after intervention, after controlling for baseline performance
Time Frame: 40-Week Post-Intervention Follow-up
6-Item Multidimensional Scale of Perceived Social Support (MSPSS-6) was used as a measure of self-reported support from family, friends, and a significant other. Scores range from 1-7, with higher scores denoting greater perceived social support.
40-Week Post-Intervention Follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Indiana University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Aging (NIA)
Alzheimer's Therapeutic Research Institute
Alzheimer's Association
Tai Chi Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dustin B Hammers, PhD, Indiana University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 11, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 28, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 5, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 10, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 14594
  • AARG-22-926940 (Other Grant/Funding Number: Alzheimer's Association)
  • 1K23AG080071-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Other researchers can contact the PI to request copies of the study data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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