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

NCT ID: NCT05573490

Last Updated: 2025-10-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-11
• Study Completion Date: 2028-06-30

Brief 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.

Conditions

Alzheimer Disease, Early Onset

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Experimental Cognitive Training and Tai Chi- Qi Gong Arm

Participants receiving 14 weeks of Cognitive Training (BrainHQ) and Tai Chi- Qi Gong exercise training

Group Type: EXPERIMENTAL

Cognitive Training

Intervention Type: DEVICE

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.

Tai Chi- Qi Gong

Intervention Type: BEHAVIORAL

Participants will be asked to complete 14 hours of training total (in 30-minute sessions, 2 days per week for 14 weeks).

Active Control Arm

Participants receiving 14 weeks of Brain Games (BrainHQ) and stretching

Group Type: ACTIVE_COMPARATOR

Brain Games

Intervention Type: DEVICE

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.

Stretching

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: DEVICE

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).

Intervention Type: BEHAVIORAL

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.

Intervention Type: DEVICE

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

BrainHQ; BrainHQ

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alzheimer's Association

OTHER

Sponsor Role: collaborator

Tai Chi Foundation

UNKNOWN

Sponsor Role: collaborator

Alzheimer's Therapeutic Research Institute

OTHER

Sponsor Role: collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Dustin Hammers

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dustin B Hammers, PhD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

Indiana University

Indianapolis, Indiana, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Dustin B Hammers, PhD

Role: CONTACT

hammersd@iu.edu

3179638557

Facility Contacts

Dustin B Hammers, PhD

Role: primary

hammersd@iu.edu

317-963-8557

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

AARG-22-926940

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

1K23AG080071-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

14594

Identifier Type: -

Identifier Source: org_study_id