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

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: Recruiting
• Conditions: Alzheimer Disease, Early Onset
• Intervention / Treatment: Device: Cognitive Training; Behavioral: Tai Chi- Qi Gong; Device: Brain Games; Behavioral: Stretching

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: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: 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: Dustin B Hammers, PhD; Phone Number: 317-963-8557; Email: hammersd@iu.edu
      • Principal Investigator: Dustin B Hammers, PhD

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 15 minutes per session. This will total of approximately 7 hours over the course of 14 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	40-Week Post-Intervention Follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	40-Week Post-Intervention Follow-up

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: National Institute on Aging (NIA); Alzheimer's Therapeutic Research Institute; Alzheimer's Association; Tai Chi Foundation
• Investigators: Principal Investigator: Dustin B Hammers, PhD, Indiana University

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2024
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: September 28, 2022
• First Submitted That Met QC Criteria: October 5, 2022
• First Posted (Actual): October 10, 2022

Study Record Updates

• Last Update Posted (Estimated): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 1, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: cognition; exercise training; cognitive training; lifestyle intervention
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID 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