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

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.

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.

Interventions

• 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 20-30 minutes per session. This will total 14 hours over the course of 14 weeks.

Primary outcome measures

• Performance on CANTAB Connect computerized Memory Composite immediately post-intervention, after controlling for baseline performance [Time frame: 15-Week Post-Intervention Follow-up]
• Performance on CANTAB Connect computerized Executive Composite immediately post-intervention, after controlling for baseline performance [Time frame: 15-Week Post-Intervention Follow-up]
• Performance on CANTAB Connect computerized Memory Composite 26 weeks after intervention, after controlling for baseline performance [Time frame: 40-Week Post-Intervention Follow-up]
• Performance on CANTAB Connect computerized Executive Composite 26 weeks after intervention, after controlling for baseline performance [Time frame: 40-Week Post-Intervention Follow-up]

Secondary outcome measures (12)

• 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]
• 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]
• Performance on scales of functioning immediately post-intervention, after controlling for baseline performance [Time frame: 15-Week Post-Intervention Follow-up]
• Performance on scales of functioning 26 weeks after intervention, after controlling for baseline performance [Time frame: 40-Week Post-Intervention Follow-up]
• Self-reported depression immediately post-intervention, after controlling for baseline performance [Time frame: 15-Week Post-Intervention Follow-up]
• Self-reported depression 26 weeks after intervention, after controlling for baseline performance [Time frame: 40-Week Post-Intervention Follow-up]
• Self-reported quality of life immediately post-intervention, after controlling for baseline performance [Time frame: 15-Week Post-Intervention Follow-up]
• Self-reported quality of life 26 weeks after intervention, after controlling for baseline performance [Time frame: 40-Week Post-Intervention Follow-up]
• Self-reported stress immediately post-intervention, after controlling for baseline performance [Time frame: 15-Week Post-Intervention Follow-up]
• Self-reported stress 26 weeks after intervention, after controlling for baseline performance [Time frame: 40-Week Post-Intervention Follow-up]
• Self-reported perceived social support immediately post-intervention, after controlling for baseline performance [Time frame: 15-Week Post-Intervention Follow-up]
• Self-reported perceived social support 26 weeks after intervention, after controlling for baseline performance [Time frame: 40-Week Post-Intervention Follow-up]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Supportive care

Study locations

United States · 1 center

• Indiana University — Indianapolis

Identifiers

NCT: NCT05573490 · 14594 · AARG-22-926940 · 1K23AG080071-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗