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

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

Recruiting
40-75 years
All
Phase N/A

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Overview

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.

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

Study details
    Alzheimer Disease
    Early Onset

NCT05573490

Indiana University

1 November 2025

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