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

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.

Conditions

• Alzheimer Disease, Early Onset

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.

Sponsors & Collaborators

• Alzheimer's Association

  collaborator OTHER

• Tai Chi Foundation

  collaborator UNKNOWN

• Alzheimer's Therapeutic Research Institute

  collaborator OTHER

• National Institute on Aging (NIA)

  collaborator NIH

• Indiana University

  lead OTHER

Principal Investigators

• Dustin B Hammers, PhD · Indiana University

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-01-11

Primary Completion

2028-06-30

Completion

2028-06-30

FDA Device

Yes

Countries

• United States

Study Locations