RecruitingNot ApplicableNCT05573490

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


Sponsor

Indiana University

Enrollment

60 participants

Start Date

Jan 11, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 40 YearsMax Age: 75 Years

Inclusion Criteria7

  • 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 Criteria1

  • • Have access to the internet (e.g., home, family, public library, etc.) for less than 4 hours per week

Interventions

DEVICECognitive 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.

BEHAVIORALTai 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).

DEVICEBrain 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.

BEHAVIORALStretching

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.


Locations(1)

Indiana University

Indianapolis, Indiana, United States

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NCT05573490


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