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

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Indiana University
Study ID
NCT05573490
Status
Recruiting
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Conditions

  • Alzheimer Disease, Early Onset

Eligibility Criteria

Sex
ALL
Age
40 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Cognitive Training — 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 — BEHAVIORAL
    Participants will be asked to complete 14 hours of training total (in 30-minute sessions, 2 days per week for 14 weeks).
  • Brain Games — 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 — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Jan 11, 2024
Status verified
May 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Experimental Cognitive Training and Tai Chi- Qi Gong Arm
    Participants receiving 14 weeks of Cognitive Training (BrainHQ) and Tai Chi- Qi Gong exercise training
  • Active Comparator: Active Control Arm
    Participants receiving 14 weeks of Brain Games (BrainHQ) and stretching

Primary Outcome Measure

Performance on CANTAB Connect computerized Memory Composite immediately post-intervention, after controlling for baseline performance [ Time Frame: 15-Week Post-Intervention Follow-up ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Indiana UniversityIndianapolisIndiana46202
Dustin B Hammers, PhD
[email protected]
3179638557
Dustin B Hammers, PhD (PRINCIPAL_INVESTIGATOR)

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Indiana University· Indianapolis, IN

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