Back to Trials
NCT05573490NARecruiting

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

Indiana University

Start Date

1/11/2024

Completion Date

6/1/2028

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.

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.

Eligibility Criteria

Age Range: 40 years to 75 years

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

Interventions

DEVICE

Cognitive Training

BEHAVIORAL

Tai Chi- Qi Gong

DEVICE

Brain Games

BEHAVIORAL

Stretching

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Alzheimer Disease, Early Onset

Locations

Indiana University

Indianapolis, Indiana 46202

United States