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

Alzheimer Disease, Early Onset Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05573490
• Other study ID #: 14594
• Secondary ID: AARG-22-9269401K
• Status: Recruiting
• Phase: N/A
• Start date: January 11, 2024
• Est. completion date: June 2028

Study information

• Verified date: March 2024
• Source: Indiana University
• Contact: Dustin B Hammers, PhD
• Phone: 3179638557
• Email: hammersd[@]iu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2028
• Est. primary completion date: June 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer Disease, Early Onset

Intervention

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 15 minutes per session. This will total of approximately 7 hours over the course of 14 weeks.

Locations

Country	Name	City	State
United States	Indiana University	Indianapolis	Indiana

Sponsors (5)

Lead Sponsor	Collaborator
Indiana University	Alzheimer's Association, Alzheimer's Therapeutic Research Institute, National Institute on Aging (NIA), Tai Chi Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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