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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

LITES Trial 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.Check my eligibility
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.See study design
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.

LITES Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~40-week post-intervention follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and 40-week post-intervention follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Interventional procedure
Performance on CANTAB Connect computerized Executive Composite immediately post-intervention, after controlling for baseline performance
Interventional procedure
+1 more
Secondary outcome measures
Interventional procedure
Benefit from Cognitive Training using Cognitive Self-Report Questionnaire immediately post-intervention, after controlling for baseline performance
Interventional procedure
+7 more

LITES Trial 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
1,675 Previous Clinical Trials
28,020,865 Total Patients Enrolled
Alzheimer's Therapeutic Research InstituteOTHER
16 Previous Clinical Trials
58,745 Total Patients Enrolled
Tai Chi FoundationUNKNOWN

Media Library

Stretching Clinical Trial Eligibility Overview. Trial Name: NCT05573490 — N/A
Alzheimer's Disease Research Study Groups: Experimental Cognitive Training and Tai Chi- Qi Gong Arm, Active Control Arm
Alzheimer's Disease Clinical Trial 2023: Stretching Highlights & Side Effects. Trial Name: NCT05573490 — N/A
Stretching 2023 Treatment Timeline for Medical Study. Trial Name: NCT05573490 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the primary purpose of this research endeavor?

"The primary aim of this study, which is being measured over a 15-week post-intervention follow-up period, is to assess performance on the CANTAB Connect computerized Executive Composite after baseline adaptation. Secondary objectives include self-reported depression (21-item Beck Depression Inventory - 2), scales of functioning (Alzheimer's disease Cooperative Study - Activities of Daily Living Inventory) and benefit from cognitive training using Cognitive Self Report Questionnaire immediately post intervention with subsequent control for baseline levels. These measures are each graded on an appropriate scale ranging between 0 and 63/78/125 respectively; higher scores in each case denote either greater symptoms"

Answered by AI

Are any openings available for prospective participants in this research?

"ClinicalTrials.gov data suggests that this research trial is currently not seeking participants, as the last update was on October 5th 2022—even though it was initially posted on January 1st 2023. Despite this, there are over 500 other trials which remain open to recruitment right now."

Answered by AI

Who qualifies to join this research program?

"This medical trial is recruiting seniors aged 40 to 75 with a diagnosis of Alzheimer's disease. Eligibility criteria include: Enrolled in the Longitudinal Early-Onset AD Study (LEADS) parent study, Diagnosed as amyloid-positive via LEADS consensus criteria for Early Onset Alzheimer's Disease, Fluency in English language and general good health free from neurological disorder, Knowledgeable informant available, Clinical Dementia Rating scale score 0.5 to 1.0 at time of enrollment into LEADS; Sufficient vision, hearing comprehension and manual dexterity necessary for testing/training program participation."

Answered by AI

Does this experimental research involve elderly participants?

"As outlined by the study's criteria, eligible participants must abide by an age range of 40 to 75 years old."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
Pennsylvania
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+
Recent research and studies
clinicaltrials.govStudy
Lifestyle Interventions for the Treatment of Early Onset Alzheimer's Disease Study
Dustin Hammers 2024. "Lifestyle Interventions for the Treatment of Early Onset Alzheimer's Disease Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05573490.
All > Alzheimers Disease Cincinnati
~40 spots leftby Jun 2028
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