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NCT Number: NCT05573490

Lifestyle Interventions for the Treatment of Early Onset Alzheimer's Disease 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.

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Key information

Conditions

Alzheimer Disease, Early Onset Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University

Indianapolis, Indiana, 46202, United States

Location status: Recruiting

Location contact

Dustin B Hammers, PhD

CONTACT

[email protected]

3179638557

Dustin B Hammers, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Training

Device

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

Tai Chi- Qi Gong

Behavioral

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

brain games

Device

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

Stretching

Behavioral

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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dustin B Hammers, PhD

CONTACT

[email protected]

3179638557

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Alzheimer's Association
  • Alzheimer's Therapeutic Research Institute
  • National Institute on Aging (NIA)
  • Tai Chi Foundation

Registry information

Acronym: LITES

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Oct 10, 2022
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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