Alzheimer Disease, Early OnsetLITESNCT05573490
Lifestyle Interventions for the Treatment of Early Onset Alzheimer's Disease Study
A study testing Cognitive Training, Tai Chi- Qi Gong and Brain Games in people with Alzheimer Disease, Early Onset, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Alzheimer Disease, Early Onset
- What is being tested?
- Cognitive Training, Tai Chi- Qi Gong and Brain Games
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jan 2024to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Have access to the internet (e.g., home, family, public library, etc.) for less than 4 hours per week
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Indiana University
Indianapolis, Indiana, 46202
Dustin B Hammers, PhD, 3179638557, hammersd@iu.edu
Dustin B Hammers, PhD
About this study
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.
Read the 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.
- Conditions
- Alzheimer Disease, Early Onset
- Being tested
- Cognitive Training, Tai Chi- Qi Gong, Brain Games, Stretching
- Keywords
- lifestyle intervention, cognitive training, exercise training, cognition
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive TrainingDevice
Also called BrainHQ
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 GongBehavioural
Participants will be asked to complete 14 hours of training total (in 30-minute sessions, 2 days per week for 14 weeks).
Brain GamesDevice
Also called BrainHQ
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.
StretchingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Cognitive Training and Tai Chi- Qi Gong Arm | Experimental | Participants receiving 14 weeks of Cognitive Training (BrainHQ) and Tai Chi- Qi Gong exercise training Receives: Device: Cognitive Training; Behavioral: Tai Chi- Qi Gong |
| Active Control Arm | Active comparator | Participants receiving 14 weeks of Brain Games (BrainHQ) and stretching Receives: Device: Brain Games; Behavioral: Stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance on CANTAB Connect computerized Memory Composite immediately post-intervention, after controlling for baseline performance
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.
Measured: 15-Week Post-Intervention Follow-up
Performance on CANTAB Connect computerized Executive Composite immediately post-intervention, after controlling for baseline performance
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.
Measured: 15-Week Post-Intervention Follow-up
Performance on CANTAB Connect computerized Memory Composite 26 weeks after intervention, after controlling for baseline performance
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.
Measured: 40-Week Post-Intervention Follow-up
Performance on CANTAB Connect computerized Executive Composite 26 weeks after intervention, after controlling for baseline performance
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.
Measured: 40-Week Post-Intervention Follow-up
Secondary outcomes (12)
Benefit from Cognitive Training using Cognitive Self-Report Questionnaire immediately post-intervention, after controlling for baseline performance
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.
Measured: 15-Week Post-Intervention Follow-up
Benefit from Cognitive Training using Cognitive Self-Report Questionnaire 26 weeks after intervention, after controlling for baseline performance
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.
Measured: 40-Week Post-Intervention Follow-up
Performance on scales of functioning immediately post-intervention, after controlling for baseline performance
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.
Measured: 15-Week Post-Intervention Follow-up
Performance on scales of functioning 26 weeks after intervention, after controlling for baseline performance
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.
Measured: 40-Week Post-Intervention Follow-up
Self-reported depression immediately post-intervention, after controlling for baseline performance
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.
Measured: 15-Week Post-Intervention Follow-up
Self-reported depression 26 weeks after intervention, after controlling for baseline performance
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.
Measured: 40-Week Post-Intervention Follow-up
Self-reported quality of life immediately post-intervention, after controlling for baseline performance
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.
Measured: 15-Week Post-Intervention Follow-up
Self-reported quality of life 26 weeks after intervention, after controlling for baseline performance
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.
Measured: 40-Week Post-Intervention Follow-up
Self-reported stress immediately post-intervention, after controlling for baseline performance
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.
Measured: 15-Week Post-Intervention Follow-up
Self-reported stress 26 weeks after intervention, after controlling for baseline performance
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.
Measured: 40-Week Post-Intervention Follow-up
Self-reported perceived social support immediately post-intervention, after controlling for baseline performance
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.
Measured: 15-Week Post-Intervention Follow-up
Self-reported perceived social support 26 weeks after intervention, after controlling for baseline performance
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.
Measured: 40-Week Post-Intervention Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start11 Jan 2024
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer Disease, Early OnsetStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized into one of two conditions: (1) Computerized Cognitive Training + Tai Chi Exercise or (2) Active Control.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Alzheimer's Association, Tai Chi Foundation, Alzheimer's Therapeutic Research Institute, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Dustin Hammers, Indiana University
- Investigators
- Dustin B Hammers, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05573490
- Sponsor's protocol ID
- 14594
- Other IDs
- AARG-22-926940, 1K23AG080071-01
- Acronym
- LITES
- Status last verified
- May 2026
- First submitted
- 28 Sep 2022
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Other researchers can contact the PI to request copies of the study data.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle Interventions for the Treatment of Early Onset Alzheimer's Disease Study
- ClinicalTrials.gov ID
- NCT05573490
- Acronym / sponsor ID
- LITES / 14594
- Conditions
- Alzheimer Disease, Early Onset
- Keywords
- lifestyle intervention, cognitive training, exercise training, cognition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Alzheimer's Association, Tai Chi Foundation, Alzheimer's Therapeutic Research Institute, National Institute on Aging (NIA)
- Study start
- 11 Jan 2024 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 10 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized into one of two conditions: (1) Computerized Cognitive Training + Tai Chi Exercise or (2) Active Control.
| Arm | Type | Receives |
|---|---|---|
| Experimental Cognitive Training and Tai Chi- Qi Gong Arm | Experimental | Device: Cognitive Training, Behavioral: Tai Chi- Qi GongParticipants receiving 14 weeks of Cognitive Training (BrainHQ) and Tai Chi- Qi Gong exercise training |
| Active Control Arm | Active comparator | Device: Brain Games, Behavioral: StretchingParticipants receiving 14 weeks of Brain Games (BrainHQ) and stretching |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (1 listed)
- Have access to the internet (e.g., home, family, public library, etc.) for less than 4 hours per week
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive TrainingAlso: BrainHQParticipants 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. | Device | Experimental Cognitive Training and Tai Chi- Qi Gong Arm |
| Tai Chi- Qi GongParticipants will be asked to complete 14 hours of training total (in 30-minute sessions, 2 days per week for 14 weeks). | Behavioural | Experimental Cognitive Training and Tai Chi- Qi Gong Arm |
| Brain GamesAlso: BrainHQParticipants 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. | Device | Active Control Arm |
| StretchingParticipants 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. | Behavioural | Active Control Arm |
Primary outcome
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.
12 secondary outcomes
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
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
Performance on scales of functioning immediately post-intervention, after controlling for baseline performance
Time frame: 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
Self-reported depression immediately post-intervention, after controlling for baseline performance
Time frame: 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
Self-reported quality of life immediately post-intervention, after controlling for baseline performance
Time frame: 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
Self-reported stress immediately post-intervention, after controlling for baseline performance
Time frame: 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
Self-reported perceived social support immediately post-intervention, after controlling for baseline performance
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No. Other researchers can contact the PI to request copies of the study data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dustin B Hammers, PhD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Training, Tai Chi- Qi Gong and Brain Games in people with Alzheimer Disease, Early Onset, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dustin B Hammers, PhD (3179638557, hammersd@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.