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Lifestyle Interventions for Early Onset Alzheimer's Disease (LITES Trial)
N/A
Recruiting
Led By Dustin B Hammers, PhD
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 40-week post-intervention follow-up
Awards & highlights
Summary
This trial studies the effects of computer and Tai Chi-Qi Gong training on those with early-onset Alzheimer's. It is hoped that these activities can improve cognition, functioning, and mood.
Who is the study for?
This trial is for people aged 40-64 with Early-Onset Alzheimer's Disease, who are in good health without other neurological disorders. Participants must be fluent in English, have an informant, and be able to see, hear, understand and perform tasks well enough to engage in the study activities.
What is being tested?
The study is testing if brain games and Tai Chi-Qi Gong can improve cognition, functioning, and mood in those with Early-Onset Alzheimer's. It compares computerized cognitive training (experimental) against stretching exercises (control) to see which is more effective.
What are the potential side effects?
Since this trial involves non-invasive activities like brain games and Tai Chi-Qi Gong exercises, side effects may include muscle soreness or fatigue from physical activity. Cognitive training typically does not cause adverse side effects.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 40-week post-intervention follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~40-week post-intervention follow-up
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Interventional procedure
Performance on CANTAB Connect computerized Executive Composite immediately post-intervention, after controlling for baseline performance
Interventional procedure
+1 moreSecondary study objectives
Interventional procedure
Benefit from Cognitive Training using Cognitive Self-Report Questionnaire immediately post-intervention, after controlling for baseline performance
Interventional procedure
+7 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental Cognitive Training and Tai Chi- Qi Gong ArmExperimental Treatment2 Interventions
Participants receiving 14 weeks of Cognitive Training (BrainHQ) and Tai Chi- Qi Gong exercise training
Group II: Active Control ArmActive Control2 Interventions
Participants receiving 14 weeks of Brain Games (BrainHQ) and stretching
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive Training
2008
Completed Phase 3
~4100
Find a Location
Who is running the clinical trial?
National Institute on Aging (NIA)NIH
1,733 Previous Clinical Trials
28,054,943 Total Patients Enrolled
Alzheimer's Therapeutic Research InstituteOTHER
17 Previous Clinical Trials
58,165 Total Patients Enrolled
Tai Chi FoundationUNKNOWN
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am part of the LEADS study and have early-onset Alzheimer's confirmed by tests.I am between 40 and 64 years old.I am in good health and do not have any neurological disorders.I can see, hear, understand, and use my hands well enough to take part in tests and training.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental Cognitive Training and Tai Chi- Qi Gong Arm
- Group 2: Active Control Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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