RecruitingNot Applicable

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

United States60 participantsStarted 2024-01-11

Plain-language 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.

Who can participate

Age range

40 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Performance on CANTAB Connect computerized Memory Composite immediately post-intervention, after controlling for baseline performance

Timeframe: 15-Week Post-Intervention Follow-up

Performance on CANTAB Connect computerized Executive Composite immediately post-intervention, after controlling for baseline performance

Timeframe: 15-Week Post-Intervention Follow-up

Performance on CANTAB Connect computerized Memory Composite 26 weeks after intervention, after controlling for baseline performance

Timeframe: 40-Week Post-Intervention Follow-up

Performance on CANTAB Connect computerized Executive Composite 26 weeks after intervention, after controlling for baseline performance

Timeframe: 40-Week Post-Intervention Follow-up

Trial details

NCT IDNCT05573490

SponsorIndiana University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-06

Contact for this trial

Dustin B Hammers, PhD

3179638557 hammersd@iu.edu

View on ClinicalTrials.gov More Alzheimer Disease, Early Onset trials

Plain-language summary

Who can participate

Age range

40 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Performance on CANTAB Connect computerized Memory Composite immediately post-intervention, after controlling for baseline performance

Timeframe: 15-Week Post-Intervention Follow-up

Performance on CANTAB Connect computerized Executive Composite immediately post-intervention, after controlling for baseline performance

Timeframe: 15-Week Post-Intervention Follow-up

Performance on CANTAB Connect computerized Memory Composite 26 weeks after intervention, after controlling for baseline performance

Timeframe: 40-Week Post-Intervention Follow-up

Performance on CANTAB Connect computerized Executive Composite 26 weeks after intervention, after controlling for baseline performance

Timeframe: 40-Week Post-Intervention Follow-up